Frying pan test at Cybathlon 2024 [has a “clinical trial” gone wrong? shouldn’t this type of research be registered properly?]

Implementation of absurdist Cybathlon frying pan / apple test

This.

I manage to grasp the handle fast and carry the pan filled with a random apple without any issue. Fast, easy. My prosthesis also works with a reliability of about 100% when I sweat, even profusely. I am not bragging – that is what well designed body powered arms do. I am allowed to test my own prostheses on myself, I also have a written declaration from our ethics committee that they see no legal reason from human research laws that prevent me from performing such tests or try outs myself (BASEC-Nr. Req-2017-00088). So I am totally allowed to perform self limited self authorized self tests with devices or parts of my choice or own design and also publish these scientifically. This may be an unusually high degree of individual compliance, admitted.

This activity, though! Who spends time that way.

Why explain things, like, at all? Why read things, like, at all?

It is obvious that things are the way they are. But, is it? Is it obvious?

People that believe they “see”, take in visually, what is the issue with arm amputees, tend to miss the far more complex reality [link]. From that, which constitutes a major epistemic error, they appear to predominantly conclude that any shitty contraption as “prosthetic arm” is already great [link], and on top, that more features on a prosthetic arm are necessarily better, which is also wrong [link]. With that, they tend to be so convinced in their own mind that they miss the unforgiving decisions we, as users of prosthetic arms, apply [link]. After they did that for a while, they by and large appear to succumb to any variation of the sunk cost fallacy, and hang on to their own “arguments” with tenacity, which may be detrimental when trying to stay in touch, via eye-to-eye communication with us, the arm amputees [link]. They will then, generally, spend extra efforts denigrating prosthetic hooks [link]. The result is a situation with stalling myoelectric performances [link][link] and negative user experiences [link][link].

Accessibility thus becomes a different subject altogether: non-disabled people seriously risk to be totally locked out from our realities, mostly based on their own mental limitations that preclude any sensible relevant contact and dialog with amputees [link]. They seem to believe that talking “to” us is equivalent to talking “with” us. But our own (arm amputee life based real and tangible, hard earned [link]) insights cannot be heard, taken in, processed properly and thus understood by such non-disabled people, particularly academic researchers that are at a greater risk due to their typical disposition [link]. On top, real physical problems aren’t recognized and sought out by researchers and engineers in order to build prosthetic parts [link]. Instead, they believe us to be “crazy” or “unfit to cognitively judge reality” [link], as mainly, we do not “appear” competent, and our rejection of their strange approach makes us reject them. Lack of visual credibility of arm amputees also can be seen as a direct effect of prosthetic industries consistently failing to provide us with proper attire towards that aspect of appearance [link], but that only as a side comment.

The bottom line is that any non-disabled person that cannot, does not, or will not hear or read our arguments, in order to develop a true understanding, risks to view us as crazy, incompetent, deranged – which bases on the logic that only after logical and consistent arguments are understood, the view can be acknowledged, not before [link].

In order for you to follow through here, you would have had to click each of the referenced links and read the whole material. You did not, and that is where that leaves you: thinking all this is “crazy”.

At least, you may have to realize that your epistemic lack of symmetry is known, and the problem bases on just this: your own stereotypes risk to lock you in, and that lack of knowledge can make you more vulnerable than one might have expected [link].

The Cybathlon test requires balancing of balls in a frying pan

So on October 25 and 26 2024, arm prosthesis candidates that signed up to the Cybathlon or, more likely, that were signed up by a research team or company, performed tasks related to academic performance tests (such as the “clothespin” test or “hot wire test”) and so they competed in a large sports arena with dozens of spectators watching.

These tasks are by and large weird, at least from my own experienced user view. This is relevant also because it clearly denotes them as “academic research” related task, which is distinct from device-compliant prosthetic use as encountered in daily life and as adequately managed by the amputee.

In the world of the ETH and there, in the eyes of the Cybathlon creators, however, a frying pan is “typically” used to balance spherical balls when demonstrating the amputee circus to the public, so, clearly, they are idiosyncratically living in their own world. As a test quirk for Cybathlon, the prosthetic arm must be used to grip and hold the frying pan handle, which thus is colored blue.

You read that right.

We do wonder, if one day, they come out with a recipe book or even a household book full of tips and tricks, that allow a further glimpse into their “thinking”. The ETH Cookbook for Arm Amputees! The ETH Wood Workbook for Arm Amputees!

As it is, they seem to believe that us arm amputees, by and large, use a frying pan handle with a circular cross section to balance plastic balls on a daily basis, as typical correlate for our daily lives. That this constitutes a relevant task given that they actually do not care about actual research/use issue such as slowly deteriorating myoelectric correct control percentages [link] and other questionable projects [link] [link].

Real life and household, cooking, eating, etc.: how it is done

In real life, I do these things to cover household work, tasks related to eating or other tasks:

  • I will buy a maximally convenient object, pot, pan, tool, device; so I will get a pepper mill that suits my need, or I may buy an iron to iron clothes that has a separate water tank and thus weighs a bit less [link].
  • I will modify objects, tools, things. So I may add tape to increase grip performance for a broom, I may enforce the stability of a vacuum cleaner hose by adding duct tape to critical parts that otherwise risk to come apart.
  • I will wear a terminal device that suits the particular task, and to allow that to happen easily, I do have the terminal devices I really use and need, and, I have a wrist connector and cable connector that is built for easy device swaps.
  • When I perform some repetitive task, I take my time, but, to do it properly with regard to posture and grip. There is no one chasing me when hanging laundry, so doing such in a hurried fashion with a stop watch makes no sense. Of course, after a while of doing these things, one becomes more proficient. But there is also no real meaning in training “pilots” of a Cybathlon to perform laundry hanging tasks such as placing a clothespin when that is not something they do routinely.
  • I ask for help: when I am faced with particularly inconvenient objects or tools, like, a restaurant with blunt knives, or a pepper mill that is stuck and does not work, the thing to do is to ask the waitress or waiter or someone else to help.
  • As a community of users, by and large, we all know that myoelectric arms are junk [link] [link] [link]

And of course all of that is lethally unspectacular. No one ever said that using a prosthetic arm (or not) is “spectacular” in any way. That is all and only thanks to the effort of the clinical trials put upon the amputee community by the makers of Cybathlon that we get tasks that are as spectacular as balancing red balls in a frying pan.

The Cybathlon tests may have to be considered to constitute a “clinical trial”

How is Cybathlon a research event, and how is it focused on medical device relevant metrics or performance? The aim/purpose is what gives the elements away that have to be considered in the question whether this all is in fact a clinical trial.

Aim/purpose: Cybathlon poses as “medical device” and its brand designation is an explicitly specified research focus

The 30.10.2024 Linkedin page of Cybathlon exhibits its denomination explicitly as “medical device”, as inscribed on that page underneath the logo and brand name.

 

The “Cybathlon” brand name is registered (Swissreg, 30.10.2024, all registered to “ETH Zürich, ETH transfer, Rämistrasse 101, 8092 Zürich”) for the following services and aims, goals and profits:

  • 3 Washing and bleaching preparations; cleaning, polishing, degreasing, and abrasive preparations; soaps; perfumery, essential oils, personal care and beauty products, hair lotions; dentifrices.
  • 5 Pharmaceutical and veterinary products; hygiene preparations for medical purposes; dietary foods and products for medical or veterinary purposes, baby food; dietary supplements for humans and animals; plasters, bandaging materials; dental filling materials and impression compounds; disinfectants.
  • 7 Engines (excluding engines for land vehicles); couplings and transmission devices (excluding those for land vehicles); vending machines; robots, their parts and accessories, as far as not included in other classes; robots and motors for powering prostheses, orthoses, and artificial exoskeletons, their parts and accessories, as far as not included in other classes; robotic suits and exoskeletons, their parts and accessories, as far as not included in other classes.
  • 9 Scientific, nautical, surveying, photographic, cinematographic, optical, weighing, measuring, signaling, checking, life-saving, and teaching apparatus and instruments; spectacles, sunglasses, sports glasses; apparatus and instruments for conducting, distributing, converting, storing, regulating, or controlling electric current; devices for recording, transmission, and reproduction of sound and images; recorded and unrecorded electronic, magnetic, optical, and magneto-optical data carriers; records; video cassettes and disks; audio cassettes and disks; CDs, DVDs, and other digital recording media; audio recordings; video recordings; audiovisual recordings; cinematographic films; animated films; downloadable electronic data and publications; mechanisms for coin-operated apparatus; cash registers, calculating machines, data processing hardware, computers; computer software; brain-computer interfaces; computer games; fire extinguishers.
  • 10 Surgical, medical, dental, and veterinary instruments and apparatus; medical robots; artificial exoskeletons for performing surgical treatments; artificial limbs, eyes, and teeth; orthopedic articles; surgical suture materials; prostheses, orthoses, and medical and orthopedic exoskeletons, their parts and accessories, as far as not included in other classes.
  • 12 Vehicles; apparatus for transportation by land, air, or water; vehicles for people with amputations, disabilities, or limited mobility; wheelchairs.
  • 14 Precious metals and their alloys, and goods made of or plated with these materials, as far as not included in other classes; jewelry, gemstones; timepieces and chronometric instruments.
  • 16 Paper, cardboard, and goods made from these materials, as far as not included in other classes; printed matter; bookbinding materials; photographs, stationery; adhesives for stationery or household purposes; artists’ materials; paintbrushes; typewriters and office requisites (except furniture); teaching and instructional materials (except apparatus); plastic packaging materials as far as not included in other classes; printing type; printing blocks.
  • 18 Leather and imitations of leather, and goods made from these materials, as far as not included in other classes; hides and skins; bags, folders, travel and handbags, sports bags; toiletry bags; wallets, purses; key cases; umbrellas and parasols; walking sticks; whips, harness, and saddlery.
  • 25 Clothing, footwear, headgear; gloves (clothing).
  • 28 Games, toys; gymnastic and sports articles, as far as not included in other classes; Christmas tree decorations; playing cards; sports gloves; gymnastic and sports articles for people with amputations, disabilities, or limited mobility.
  • 32 Beers; mineral and carbonated waters and other non-alcoholic beverages; fruit drinks and fruit juices; syrups and other preparations for making beverages.
  • 33 Alcoholic beverages (excluding beers).
  • 41 Education; training; entertainment; sports and cultural activities.
  • 41 Education; training; entertainment; sports and cultural activities; organizing and conducting sports events; providing non-downloadable data and publications; providing sports information.
  • 42 Scientific and technological services and research and designer services related thereto; industrial analysis and research services; design and development of computer hardware and software.
  • 42 Scientific and technological services and research and designer services related thereto; industrial analysis and research services; design and development of computer hardware and software; design and development of prostheses, orthoses, and exoskeletons; design and development of drives for prostheses, orthoses, and exoskeletons; providing information in the fields of bionics and prosthetics.1

    What is performed at that event is clearly one of these. So which one is it?

    While clearly, the Cybathlon competition event is not any of the registered classes of services or products 3, 5, 7, 9, 10, 12, 14, 16, 18, 25, 28, 32, 33, or even 41 (whereas you cannot possibly have amputees provide public demonstration of device failures and declare that “culture” as it rather amounts to barbarism, or even declare that type of freak show circus “entertainment” as this then would be offensive, nor is there any actual “sport” that can be recognised in the activities to be performed there by arm amputees).

    So also by exclusion, it has to be seen as their explicit aim and declared intent to conduct the Cybathlon competitive event specifically in order to carry out some type of scientific performance demonstration. The scientific studies written about Cybathlon prosthetic arm race participants exhibit this awareness and insight. As an element, this constitutes aim and purpose to be regarded as activity that constitutes research.

    Participation in Cybathlon in the prosthetic arm race is not possible without a prosthetic arm, so has to be regarded as declared, accepted and recognized as academic medical device related research.

    The Cybathlon event page itself, on LinkedIn, is tagged “medical device“, so we are not far from the mark by pointing out relevant jurisdiction.

    Aim/purpose: academic articles describing Cybathlon participation mostly declare some ethics law conformance, indicating their awareness for the need for compliance with that regard

    Studies about subjects using prosthetic arms for Cybathlon participation clearly document an awareness and acknowledgement for a required research law and ethics compliance, without however any of these providing proper reference to Swiss Clinical Trials legislation, which I believe would have to been seriously considered, given the involvement of unlicensed medical device use for performance testing under what declaredly and admittedly is given as a research setting:

    • Caserta G, Boccardo N, Freddolini M, Barresi G, Marinelli A, Canepa M, Stedman S, Lombardi L, Laffranchi M, Gruppioni E, De Michieli L. Benefits of the Cybathlon 2020 experience for a prosthetic hand user: a case study on the Hannes system. Journal of neuroengineering and rehabilitation. 2022 Jul 4;19(1):68[1]: Ethics approval and consent to participate: Written informed consent was obtained from all the subjects for publication of this study and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal. Consent for publication: All subjects gave permission for photographs and videotapes recorded during data collection to be used in publications and presentations.
    • Godfrey SB, Rossi M, Piazza C, Catalano MG, Bianchi M, Grioli G, Zhao KD, Bicchi A. SoftHand at the CYBATHLON: a user’s experience. Journal of neuroengineering and rehabilitation. 2017 Dec;14:1-2[2]: Ethics approval and consent to participate –  In-lab training was approved by the Ligurian regional ethics committee, and the SoftHand Pro team Pilot gave his consent to participate in the training and CYBATHLON competition. Consent for publication: The CYBATHLON Pilot has given his consent to the publication of the data and photos present in this manuscript.
    • Moodley K, Fourie J, Imran Z, Hands C, Rall W, Stopforth R. Touch Hand 4.5: low-cost additive manufacturing prosthetic hand participated in Cybathlon 2020 ARM discipline. Journal of NeuroEngineering and Rehabilitation. 2022 Nov 30;19(1):130[3]: Ethics declarations: Ethics approval and consent to participate: Include a statement on ethics approval and consent (even where the need for approval was waived). Include the name of the ethics committee that approved the study and the committee’s reference number if appropriate. Ethical clearance certificate HCC/0161/011. Consent for publication: All authors have given consent for publication.

    This following study is interesting, in that the research subject’s approval was neither obtained nor was ethics approval sought, or any clinical trial registration listed:

    • Mick S, Marchand C, de Montalivet É, Richer F, Legrand M, Peudpièce A, Fabre L, Huchet C, Jarrassé N. Smart ArM: a customizable and versatile robotic arm prosthesis platform for Cybathlon and research. Journal of NeuroEngineering and Rehabilitation[4]. 2024 Aug 5;21(1):136: Ethics approval and consent to participate: Not applicable. Consent for publication: All authors reviewed the paper and gave their consent for its publication.Incidentally, it is this same individual and similarly named prosthesis, where the subject suffered what appeared to be an accidental if not negligent wrist detachment (see below). So it appears that there is at least this research group where a few serious compliance questions and investigation may be in order.

    Aim/purpose: since its inception, Cybathlon has always documented and rated the performance, not qualitative aspects of any prosthetic arm device

    • The discussion what to use for performance testing may have been and still be long and difficult [link] – which may occlude the view on the simple fact that they did, do, in fact, rate, performances, and nothing else.
    • The Cybathlon website clearly states: “Cybathlon, a non-profit project of ETH Zurich, acts as a platform that challenges teams from all over the world to develop assistive technologies suitable for everyday use with and for people with disabilities. The driving force behind Cybathlon is international competitions and events, in which teams consisting of technology developers from universities, companies or NGOs and a person with disabilities tackle various everyday tasks with their latest assistive technologies. The participants with physical disabilities show how to tie shoelaces with a robotic arm prosthesis [..]. Through Cybathlon, ETH Zurich demonstrates what research and development mean for society. Since the idea was born in 2013, more than 100 teams from over 30 countries have taken part in Cybathlon competitions. “

    Very clearly, the Cybathlon measures and rates performance for the benefit of research and development, and it does so in a systematic manner.

    Risk/exposure: amputees are a vulnerable group

    Medical product and medical device legislation in Switzerland (as in the EU) is not geared towards protecting the manufacturers or prescribing clinical specialists. It is decidedly meant to protect the patients and prosthetic arm users, the amputees, in particular, in the context here.

    With that, we can ask, whether applying medical device regulation – that also covers clinical trials performed with unlicensed or off label use of prosthetic arm devices – is of particular help in this context.

    Risk/exposure 1: device failure and injury

    One risk that a user faces when a prosthetic arm fails is injury. In the case described here (below), no injury occurred but the pan and the hand could have fallen on the foot of the prosthetic arm user. Otherwise, the risk of injury does not seem high.

    Risk/exposure 2: device failure and unallowed/unauthorized use

    When demonstrating the world that prosthetic arms are routinely used to perform things no normal person would do with a prosthesis (e.g., screwing in a lightbulb while electricity is powering the socket constitutes a no-go in my personal experience; using a hammer to hammer in a nail is not something most myoelectric devices are built to do, and, with good reason), the ETH sets a difficult precedence. Also, it causes a difficult dilemma for participants that then have to decide between failure or risk. Proper application of medical device regulation should prevent the user from such avoidable embarrassment in public and from any risk that is not supported by clear device design and build.

    Clinical trials in Switzerland and Cybathlon

    In Switzerland, a clinical trial with a medical device is defined as a research investigation involving human participants to assess the device’s safety, efficacy, or performance. That is how the Cybathlon will have to be considered as likely just performing public clinical trials.

    The details of their own “TekCheck” basis – who are the specialists, what experience do they have, what actual tests do they perform – aren’t open to public review, so that seems to be a problem [see Cybathlon organizers competence check here]. Also their check protocol is not public and available for review.

    Swiss Research

    According to the Swiss Human Research Act and Ordinance on Clinical Trials with Medical Devices, a clinical trial must follow regulatory and ethical guidelines, requiring approvals from both Swissmedic and a cantonal ethics committee for categories that are not CE-marked or are used off-label​.

    A device that is used off-label can only be used as that, if it is already allowed on Swiss markets. That is, these device manufacturers will have to provide proper documentation. There, it is relevant to note that often, documentation will be deficient or incomplete, which also may make proper processing of such cases or situation quite difficult. It will be easiest to just reject applications of devices that lack complete and proper technical documentation.

    A clinical trial involves a structured, regulated setting where participants’ use related performance of what constitutes a medical device directly relates to the use of the device under investigation. Clinical trials for potential market approval typically require data collection, monitoring, and also, adherence to ethical standards to ensure participant safety and reliable data.

    Approvals from Swissmedic and the cantonal ethics committee are essential, with Swissmedic conducting a particularly rigorous review to ensure participant safety. Additionally, specific restrictions or additional requirements may apply based on the device’s prohibited status​.  In all cases, approvals require simultaneous submissions to both Swissmedic and the ethics committee, following specific guidelines and submission processes.

    In Switzerland, clinical investigations with medical devices under categories C1, C2, and C3 require specific regulatory approvals due to their off-label or unlicensed status.

    Already the use of a CE-approved myoelectric prosthetic arm for an activity such as “hammering a nail” possibly violates the statutory electric wrist connector’s product use limitation and thereby is an “off label” use, which requires approval in the setting of such a systematic performance assessment such as the Cybathlon.

    Here’s a breakdown of the approvals required for each category:

    • Category C1 (Off-Label Use of CE-Marked Devices): This category involves devices that already hold a CE mark but are used outside their intended, approved labeling. Approval is required from both Swissmedic and the cantonal ethics committee. Swissmedic assesses the safety and quality of the device in its proposed off-label use, while the ethics committee evaluates participant safety and ethical concerns​
    • Category C2 (Non-CE Marked Devices): Devices that are not CE-marked must undergo full scrutiny since they have not been previously certified for any usage within the EU or Switzerland. Both Swissmedic and the cantonal ethics committee must approve the study. This review includes an evaluation of the device’s risk profile, potential benefits, and regulatory compliance​.
    • Category C3 (Devices Restricted from Market Use): This category covers devices that may be prohibited from sale or usage in Switzerland, often due to safety concerns.

    Prosthetic arm parts and failure – general experience and perspective

    The wrist units typically used for myoelectric hands are not built to sustain physical mechanical force exposure such as blows, jerky motion under load, hammering, power tool use or pull of weights other than those encountered in light (not moderate or heavy) “office work”.

    That said, it is important to always read the tech specs of every component to understand what can be done with the prosthesis, when operating under legally correct limits also from a proper medical device legislation and safety view.

    Thereby, the limiting decimal, the limiting parameter, or technical property, of any prosthetic arm, that always is assembled using a variety of components, is that of its weakest component.

    It then clearly constitutes a cunning trick in advertising that I encountered in my own prosthetic arm parts, whereby one part (typically the gripper) is advertised to be “very robust” and that is promoted as one that “can be used for work”, when the company also places a restriction on what they believe to be “compatible” components which, in fact, are not advertised, but have a restriction on their maximum load that is far lower, such as the wrist connector, which also by statutory requirement, must be combined with such a gripper. The combined setup, the prosthetic arm, then must not undergo any loading of any kind so as not to exceed the weak part’s tender limitations. This then relieves the company from having to build their robust gripper (as advertised) to really be very robust, as the wrist will give up far earlier into physically demanding use.

    Example of manufacturer imposed weak link component combination

    So once upon a time, I was using Otto Bock’s MovoHook2Grip every day, and that was said to be combined best with the Otto Bock quick lock wrist unit. After a short while, like, a few months, the wrist started to die due to weak design/constitution, so we disassembled it to see what was wrong [link]. It failed to fix some of the manufacturer issued adapter bolts, while others spun freely, clearly indicating a range of engineering issues. Its design made it die early though, as all that kept the terminal device bolt in place was a soft spring that somehow got dilated due to me using the prosthesis for what it was prescribed for: work. That was not helped by the fact that the brand issued bolts had varying diameters as we identified. Now, I work in a field where we occasionally lift heavy items, so doing that is part of the medically prescribed purpose of my prosthesis. So, after that ominous Otto Bock wrist had died, we replaced it with a simple own design that was crude – but extremely robust: a wrist to “even tow a car”, if need be [link]. Then that happened, which the manufacturers had tried to exclude by way of component combination requirement: I managed to go further in the load and use of the hook, than I would have been able to, with the fragile wrist of Otto Bock. And then, at that level of use and exposure, that hook, the MovoHook, started to exhibit two defects, none of which Otto Bock or me had ever expected to appear: one was that the joint started to wiggle, which was a result from their truly cheap design with non-parallel joint surfaces and absence of ball joint replaced by cheap PVC discs, the other one was that the spring/metal combination was ill designed so the metal body suffered indents from the lever, which in conjunction with minimally excessive spring length would cause thin objects to now slip [link]. This means that the combination of the parts, and their limited load capabilities are worth a very close and sharp look as the user. On top, Otto Bock usually seems to suggest that the “work hook” for physically demanding work is tied to a perlon cable [link].

    Bottom line for inspectors

    Bottom line for any inspector that needs to stay on the safe side is: look for the weakest component / part, and clearly limit use cases, use situations, tasks, et cetera, to any forces and exposure well below the limits of that weakest component / part.

    Bottom line for engineers

    Bottom line for engineers that have no time for excessive testing: just overengineer the parts. Make them so robust and stable that they will survive no matter what. Then you can forgo testing. My wrist unit never was tested in a pre-market or pre-use product testing sense – but it is built as a miniaturized tram wagon coupling made from hardened Ramax steel, so what could happen. Yes, what could happen? That [link] ; )

    Device failure incident at Cybathlon 2024

    Here (see video, “Smart Arm”, user is Christophe Huchet), we have a situation, where the user performs a wrist disconnect/connect manipulation after having carried heavy bottles, which clearly already then must have placed a possibly excessive strain on the wrist, potentially causing it afterwards to fail.

    According to the Race Rules, there should have been a person identified and trained by the organizers termed “spotter”, but no “spotter” seemed to have intervened or come to help there, possibly indicating a lack of practical training before the Cybathlon, or a lack of reaction at the accident moment 2. A technical check should have been performed by the organisers as well 3. We have to assume that the Race Rules were only written as recommendation, but not to always be followed by the letter.

    Technically, a proficient user of these types of quick connect wrist for myoelectric terminal devices such as me will immediately see, in this video, and thus know, that the rotational angle where the device disconnects is around 340 to 380 degrees, so more or less a full rotation. So once I connect it and rotate it a bit, it will come off after I complete a full turn. That then also means clearly, that, if I want the hand palm up – as intended here – to have a stable mechanical (and electrical) connection, best to insert it palm down and rotate it some 180 degrees – then the hand rotation is maximally distant, away, from any rotational angle where it will mechanically disconnect. So it also seems that we may have a relatively unexperienced user, or, a very nervous user, either of which makes it necessary to identify this source of problem first, and have measures in place to have this performance test not fail in that way.

    Whether therefore this is purely accidental, or, whether there is a degree of negligence (engineering, oversight, formal approval), would be a question to definitely investigate [link] [pdf]; the related academic study (see above) is one that does not indicate any ethics or compliance conformance with regard to this individual and the prosthesis, which is unusual but seemingly was accepted by Springer publisher.

    If an unexperienced or extremely nervous user fails in a large public arena, this very much raises the question of regulatory failure, in that the whole premise of the Cybathlon is one of a clinical trial where, would the frying pan fall on the user’s or someone else’s foot, injury may result. Also, arm amputees in general are not ever to be coerced or nudged to perform fringe technology, untested beta tests, test pilot maneuvers, in an additionally adrenaline generating setting such as a public arena, as long as any academic research oversight have their fingers in the setup or process – as law should prevent, protect, the amputee from all of that.

    The fact that the wrist is used that way, and that it breaks / disconnects that way, given its propensity to disconnect at the ~360 degree rotation point, also indicates insufficient strength / robustness in construction in the first place, so we also need to ask what brand of wrist was used and how that wrist connector was clinically tested. If anything, previous testing should have allowed the constructors to add a securing mechanism.

    Video: ETH Zurich, CYBATHLON, non commercial use

    While the next attempt (video below) clearly shows an obviously very stressful attempt of the prosthetic arm user to lift the frying pan, I do not believe this contributes in any way to better research or development in prosthetic arm technology, much as the last Cybathlons clearly were not able to prevent any of these problematic situations in this very public and in this very publicized setting.

    In my personal view, this is NOT the way any, also Swiss, Technical University or we, as a society, treat arm amputees. We should not have to provide public exhibitionism with the embarrassing deficiencies of academic and industrial developments.

    There really should be laws and regulations that prevent just that.

    Video: ETH Zurich, CYBATHLON, non commercial use

    Summary

    When a Federal University of Technology (ETH) appears to fail to to properly register what clearly is set up as a clinical trial, we cannot but stare in disbelief at the surprising device failures only such a wild trip into the application of poorly developed medical devices can offer to the public.

    That our daily experience with commercial prostheses is not a bit better does not help here – but the first use of a prosthetic arm is not governed by clinical trial regulations. There, failure and device damage has to be accepted. Not here though.

    And yet, there is a sick fascination: at the moment when one is watching these trials, it is a bit like watching a Wild West Movie: you are happy you are not there but you cannot stop but watching in disbelief. Or, like watching ice skating pre-trials where every fourth contestant suffers some type of fall. In my personal opinion, the ETH under the guidance of Prof. Dr. Dr. h.c. Robert Riener effectively performs an amputee freak show circus that seems to lack professionalism, raises serious questions regarding legal underpinning and in some 10 years never resulted in even a single component that was developed as consequence or because of Cybathlon, that made life easier or prostheses better that are used for real / hard / physically demanding work. Even their own study with a review of Cybathlons past cannot cite or mention any Cybathlon-inspired innovation [5].

    Keywords: Swiss Medic. Prosthetic Arm. Armprothese. Schweiz. Aufsicht. Medizinproduktegesetz. ETH Zürich.

    [1] G. Caserta, N. Boccardo, M. Freddolini, G. Barresi, A. Marinelli, M. Canepa, S. Stedman, L. Lombardi, M. Laffranchi, E. Gruppioni, and others, “Benefits of the Cybathlon 2020 experience for a prosthetic hand user: a case study on the Hannes system,” Journal of Neuroengineering and Rehabilitation, vol. 19, iss. 1, p. 68, 2022.
    [Bibtex]
    @article{caserta2022benefits,
      title={Benefits of the Cybathlon 2020 experience for a prosthetic hand user: a case study on the Hannes system},
      author={Caserta, Giulia and Boccardo, Nicol{\`o} and Freddolini, Marco and Barresi, Giacinto and Marinelli, Andrea and Canepa, Michele and Stedman, Samuel and Lombardi, Lorenzo and Laffranchi, Matteo and Gruppioni, Emanuele and others},
      journal={Journal of Neuroengineering and Rehabilitation},
      volume={19},
      number={1},
      pages={68},
      year={2022},
      publisher={Springer}
    }
    [2] S. B. Godfrey, M. Bianchi, K. Zhao, M. Catalano, R. Breighner, A. Theuer, K. Andrews, G. Grioli, M. Santello, and A. Bicchi, “The softhand pro: Translation from robotic hand to prosthetic prototype,” in Converging Clinical and Engineering Research on Neurorehabilitation II, Springer, 2017, pp. 469-473.
    [Bibtex]
    @incollection{godfrey2017softhand,
      title={The softhand pro: Translation from robotic hand to prosthetic prototype},
      author={Godfrey, Sasha B and Bianchi, Matteo and Zhao, Kristin and Catalano, Manuel and Breighner, Ryan and Theuer, Amanda and Andrews, Karen and Grioli, Giorgio and Santello, Marco and Bicchi, Antonio},
      booktitle={Converging Clinical and Engineering Research on Neurorehabilitation II},
      pages={469--473},
      year={2017},
      publisher={Springer}
    }
    [3] K. Moodley, J. Fourie, Z. Imran, C. Hands, W. Rall, and R. Stopforth, “Touch Hand 4.5: low-cost additive manufacturing prosthetic hand participated in Cybathlon 2020 ARM discipline,” Journal of NeuroEngineering and Rehabilitation, vol. 19, iss. 1, p. 130, 2022.
    [Bibtex]
    @article{moodley2022touch,
      title={Touch Hand 4.5: low-cost additive manufacturing prosthetic hand participated in Cybathlon 2020 ARM discipline},
      author={Moodley, Kashreya and Fourie, Jode and Imran, Zaahid and Hands, Clive and Rall, William and Stopforth, Riaan},
      journal={Journal of NeuroEngineering and Rehabilitation},
      volume={19},
      number={1},
      pages={130},
      year={2022},
      publisher={Springer}
    }
    [4] S. Mick, C. Marchand, É. de Montalivet, F. Richer, M. Legrand, A. Peudpièce, L. Fabre, C. Huchet, and N. Jarrassé, “Smart ArM: a customizable and versatile robotic arm prosthesis platform for Cybathlon and research,” Journal of NeuroEngineering and Rehabilitation, vol. 21, iss. 1, p. 136, 2024.
    [Bibtex]
    @article{mick2024smart,
      title={Smart ArM: a customizable and versatile robotic arm prosthesis platform for Cybathlon and research},
      author={Mick, S{\'e}bastien and Marchand, Charlotte and de Montalivet, {\'E}tienne and Richer, Florian and Legrand, Mathilde and Peudpi{\`e}ce, Alexandre and Fabre, Laurent and Huchet, Christophe and Jarrass{\'e}, Nathana{\"e}l},
      journal={Journal of NeuroEngineering and Rehabilitation},
      volume={21},
      number={1},
      pages={136},
      year={2024},
      publisher={Springer}
    }
    [5] L. Jaeger, R. S. de Baptista, C. Basla, P. Capsi-Morales, Y. K. Kim, S. Nakajima, C. Piazza, M. Sommerhalder, L. Tonin, G. Valle, and others, “How the CYBATHLON competition has advanced assistive technologies,” Annual Review of Control, Robotics, and Autonomous Systems, vol. 6, iss. 1, pp. 447-476, 2023.
    [Bibtex]
    @article{jaeger2023cybathlon,
      title={How the CYBATHLON competition has advanced assistive technologies},
      author={Jaeger, Lukas and Baptista, Roberto de Souza and Basla, Chiara and Capsi-Morales, Patricia and Kim, Yong Kuk and Nakajima, Shuro and Piazza, Cristina and Sommerhalder, Michael and Tonin, Luca and Valle, Giacomo and others},
      journal={Annual Review of Control, Robotics, and Autonomous Systems},
      volume={6},
      number={1},
      pages={447--476},
      year={2023},
      publisher={Annual Reviews}
    }

Footnotes

  1. German original Cybathlon brand registration text:
  2. 3
    Wasch- und Bleichmittel; Putz-, Polier-, Fettentfernungs- und Schleifmittel; Seifen; Parfümeriewaren; ätherische Öle, Mittel zur Körper- und Schönheitspflege, Haarwässer; Zahnputzmittel.

    5
    Pharmazeutische und veterinärmedizinische Erzeugnisse; Hygienepräparate für medizinische Zwecke; diätetische Lebensmittel und Erzeugnisse für medizinische oder veterinärmedizinische Zwecke, Babykost; Nahrungsergänzungsmittel für Menschen und Tiere; Pflaster, Verbandmaterial; Zahnfüllmittel und Abdruckmassen für zahnärztliche Zwecke; Desinfektionsmittel.

    7
    Motoren (ausgenommen Motoren für Landfahrzeuge); Kupplungen und Vorrichtungen zur Kraftübertragung (ausgenommen solche für Landfahrzeuge); Verkaufsautomaten; Roboter, deren Bestandteile und Zubehör, soweit nicht in anderen Klassen enthalten; Roboter und Motoren für den Antrieb von Prothesen, Orthesen und künstlichen Exoskeletten, deren Bestandteile und Zubehör, soweit nicht in anderen Klassen enthalten; Roboteranzüge und robotische Exoskelette, deren Bestandteile und Zubehör, soweit nicht in anderen Klassen enthalten.

    9
    Wissenschaftliche, Schifffahrts-, Vermessungs-, fotografische, Film-, optische, Wäge-, Mess-, Signal-, Kontroll-, Rettungs- und Unterrichtsapparate und -instrumente; Brillen, Sonnenbrillen, Sportbrillen; Apparate und Instrumente für die Leitung, die Verteilung, die Umwandlung, die Speicherung, die Regulierung oder die Steuerung von elektrischem Strom; Geräte zur Aufzeichnung, Übertragung und Wiedergabe von Ton und Bild; bespielte und unbespielte elektronische, magnetische, optische und magnetooptische Datenträger; Schallplatten; Videokassetten und -disketten; Audiokassetten und -disketten; CDs, DVDs und andere digitale Aufzeichnungsträger; Audioaufzeichnungen; Videoaufzeichnungen; audiovisuelle Aufzeichnungen; kinematographische Filme; Zeichentrickfilme; herunterladbare elektronische Daten und Publikationen; Mechaniken für geldbetätigte Apparate; Registrierkassen, Rechenmaschinen, Hardware für die Datenverarbeitung, Computer; Computersoftware; Gehirn-Computer-Schnittstellen; Computerspiele; Feuerlöschgeräte.

    10
    Chirurgische, ärztliche, zahn- und tierärztliche Instrumente und Apparate; Medizinroboter; künstliche Exoskelette für die Durchführung von operativen Behandlungen; künstliche Gliedmassen, Augen und Zähne; orthopädische Artikel; chirurgisches Nahtmaterial; Prothesen, Orthesen sowie medizinische und orthopädische Exoskelette, deren Bestandteile und Zubehör, soweit nicht in anderen Klassen enthalten.

    12
    Fahrzeuge; Apparate zur Beförderung auf dem Lande, in der Luft oder auf dem Wasser; Fahrzeuge für Personen mit Amputationen, Behinderungen oder eingeschränkter Mobilität; Rollstühle.

    14
    Edelmetalle und deren Legierungen sowie daraus hergestellte oder damit plattierte Waren, soweit sie nicht in anderen Klassen enthalten sind; Juwelierwaren, Schmuckwaren, Edelsteine; Uhren und Zeitmessinstrumente.

    16
    Papier, Pappe (Karton) und Waren aus diesen Materialien, soweit sie nicht in anderen Klassen enthalten sind; Druckereierzeugnisse; Buchbinderartikel; Fotografien, Schreibwaren; Klebstoffe für Papier- und Schreibwaren oder für Haushaltszwecke; Künstlerbedarfsartikel; Pinsel; Schreibmaschinen und Büroartikel (ausgenommen Möbel); Lehr- und Unterrichtsmittel (ausgenommen Apparate); Verpackungsmaterial aus Kunststoff, soweit es nicht in anderen Klassen enthalten ist; Drucklettern; Druckstöcke.

    18
    Leder und Lederimitationen sowie Waren daraus, soweit sie nicht in anderen Klassen enthalten sind; Häute und Felle; Taschen, Mappen, Reise- und Handkoffer, Sportbeutel; Kulturbeutel; Geldbeutel, Portemonnaies; Schlüsseletuis; Regenschirme und Sonnenschirme; Spazierstöcke; Peitschen, Pferdegeschirre und Sattlerwaren.

    25
    Bekleidungsstücke, Schuhwaren, Kopfbedeckungen; Handschuhe (Bekleidung).

    28
    Spiele, Spielzeug; Turn- und Sportartikel, soweit sie nicht in anderen Klassen enthalten sind; Christbaumschmuck; Spielkarten; Sporthandschuhe; Turn- und Sportartikel für Personen mit Amputationen, Behinderungen oder eingeschränkter Mobilität.

    32
    Biere; Mineralwässer und kohlensäurehaltige Wässer und andere alkoholfreie Getränke; Fruchtgetränke und Fruchtsäfte; Sirupe und andere Präparate für die Zubereitung von Getränken.

    33
    Alkoholische Getränke (ausgenommen Biere).

    41
    Erziehung; Ausbildung; Unterhaltung; sportliche und kulturelle Aktivitäten.

    41
    Erziehung; Ausbildung; Unterhaltung; sportliche und kulturelle Aktivitäten; Veranstalten und Durchführen von Sportanlässen; Bereitstellen von nicht herunterladbaren Daten und Publikationen; Bereitstellen von Sportinformationen.

    42
    Wissenschaftliche und technologische Dienstleistungen und Forschungsarbeiten und diesbezügliche Designerdienstleistungen; industrielle Analyse- und Forschungsdienstleistungen; Entwurf und Entwicklung von Computerhardware und -software

    42
    Wissenschaftliche und technologische Dienstleistungen und Forschungsarbeiten und diesbezügliche Designerdienstleistungen; industrielle Analyse- und Forschungsdienstleistungen; Entwurf und Entwicklung von Computerhardware und -software; Entwurf und Entwicklung von Prothesen, Orthesen und Exoskeletten; Entwurf und Entwicklung von Antrieben für Prothesen, Orthesen und Exoskeletten; Bereitstellen von Informationen im Bereich Bionik und Prothetik.

  3. See PDF : Spotter: A team official to prevent the pilot from falling, to help them to move or leave the track during the race in certain disciplines. A spotter is trained to only intervene in case of an imminent risk to the pilots or their environment.
  4. Tec Check: A predefined process designed to systematically verify that an assistive device fulfils the general and discipline specific eligibility criteria, and to examine the risks for the pilots and their environment related to the use of the assistive device. The TecCheck is conducted by neutral technical examiners appointed by the CYBATHLON organising committee who will keep the provided information confidential.

Cite this article:
Wolf Schweitzer: swisswuff.ch - Frying pan test at Cybathlon 2024 [has a “clinical trial” gone wrong? shouldn’t this type of research be registered properly?]; published 29/10/2024, 22:52; URL: https://www.swisswuff.ch/tech/?p=13665.

BibTeX 1: @MISC{schweitzer_wolf_1738962628, author = {Wolf Schweitzer}, title = {{swisswuff.ch - Frying pan test at Cybathlon 2024 [has a “clinical trial” gone wrong? shouldn’t this type of research be registered properly?]}}, month = {October}, year = {2024}, url = {https://www.swisswuff.ch/tech/?p=13665}

BibTeX 2: @MISC{schweitzer_wolf_1738962628, author = {Wolf Schweitzer}, title = {{Frying pan test at Cybathlon 2024 [has a “clinical trial” gone wrong? shouldn’t this type of research be registered properly?]}}, howpublished = {Technical Below Elbow Amputee Issues}, month = {October}, year = {2024}, url = {https://www.swisswuff.ch/tech/?p=13665} }