(52 days)
The Electric wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The subject Electric wheelchair(C001) is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling. The subject device is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and outdoor road like flat stone road and so on. The subject device consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable Carbon fiber frame, two armrests, a backrest, a seat cushion, a safety belt, two rear driving wheels(8" / PU solid tire) and two front wheels(6"/ PU solid tire). The electrical part is composed of two motors, two brakes, a lithium battery, a controller and an off-board charger. The device is powered by a Li-ion battery with 14.8km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake. The device can convered between electric driving and manual push.
This is not an AI/ML device, so elements of the request regarding AI/ML tests are not applicable.
The device in question, the Electric Wheelchair (C001), is a powered medical device. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical performance testing against a series of ISO 7176 standards relevant to wheelchairs and IEC 60601-1-2 for electromagnetic compatibility.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" versus "reported device performance" in a quantitative manner for each specific parameter. Instead, it states that the device "complied with the requirements" of various ISO and IEC standards. The comparison table in Section VI outlines differences between the subject device and the predicate but doesn't explicitly state quantitative performance acceptance criteria for the subject device beyond the general statement of compliance with standards.
However, based on the non-clinical testing performed, the acceptance criteria are implicitly the successful adherence to the requirements outlined in the cited ISO and IEC standards. The "reported device performance" is the statement of this compliance. For certain parameters where the subject device differs from the predicate, the document asserts that these differences do not impact safety or effectiveness.
Below is a table summarizing the implicit acceptance criteria (compliance with standards) and the reported performance (compliance achieved).
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7176-1:2014 (Static stability) | Complied with requirements |
| ISO 7176-2:2017 (Dynamic stability of electric wheelchairs) | Complied with requirements |
| ISO 7176-3:2012 (Effectiveness of brakes) | Complied with requirements |
| ISO 7176-4:2008 (Energy consumption & theoretical distance range) | Complied with requirements |
| ISO 7176-5:2008 (Dimensions, mass, and maneuvering space) | Complied with requirements |
| ISO 7176-6:2018 (Max speed, acceleration, and deceleration) | Complied with requirements |
| ISO 7176-7:1998 (Measurement of seating and wheel dimensions) | Complied with requirements |
| ISO 7176-8:2014 (Static, impact, and fatigue strength) | Complied with requirements |
| ISO 7176-9:2009 (Climatic tests) | Complied with requirements |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Complied with requirements |
| ISO 7176-11:2012 (Test dummies) | Complied with requirements (implies use of standard dummies) |
| ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Complied with requirements (implies testing on standard surfaces) |
| ISO 7176-14:2008 (Power and control systems) | Complied with requirements |
| ISO 7176-15:1996 (Information disclosure, documentation, and labeling) | Complied with requirements |
| ISO 16840-10: 2021 (Resistance to ignition of postural support devices) | Complied with requirements |
| ISO 7176-21:2009 (Electromagnetic compatibility) | Complied with requirements |
| ISO 7176-22: 2014 (Set-up procedures) | Complied with requirements (implies proper setup for testing) |
| ISO 7176-25:2013 (Batteries and chargers for powered wheelchairs) | Complied with requirements |
| IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances) | Complied with requirements |
| Software validation | Carried out successfully |
| Biocompatibility of patient-contacting material (ISO 10993-1 equivalence) | Declared identical to predicate's materials |
2. Sample size used for the test set and the data provenance
The document describes bench performance testing according to international standards (ISO and IEC). For such tests, the "sample size" is typically not described in terms of patients or data records, but rather in terms of the number of devices or components tested. The document does not specify the exact number of electric wheelchairs (C001) or their components that underwent each of these tests.
The data provenance is laboratory testing data, presumably collected at the manufacturer's facility or a certified testing laboratory, as implied by the phrase "performance data were provided to verify that the subject device met all design specifications." The country of origin of the device is China (Zhejiang Hfizer Medical Equipment CO.,LTD.). Since these are bench tests, they are inherently prospective in relation to the current device's design and manufacturing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical medical device, not an AI/ML system requiring expert-established ground truth for its performance evaluation. The "ground truth" for this device is the established technical specifications and safety requirements set forth in the international standards (ISO and IEC) to which it was tested for compliance.
4. Adjudication method for the test set
Not applicable for a physical device undergoing bench testing. The evaluation is based on objective measurements and compliance with predefined standard requirements, not on human interpretation or adjudication of outputs.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The "ground truth" for the performance evaluation of this electric wheelchair is compliance with the technical specifications and safety criteria defined by the cited international standards (ISO 7176 series and IEC 60601-1-2). These standards provide objective, measurable criteria for various aspects of wheelchair safety and performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system and does not have a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML system and does not have a training set with associated ground truth.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).