(394 days)
- Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio
- any individual to take part in sports activities requiring an upright position
The ParaMotion is an all-terrain electric wheelchair with an integrated standing function. All functions are controlled via the joystick control panel. Strong electric motors on the front wheels with wide terrain tires ensure safe handling, and obstacles are overcome easily. The ParaMotion is steered by targeted control of the drive wheels with appropriate operation of the joystick. The dual rear wheel is freely mounted on a steering shaft and thus has a 360° turning radius. This ensures excellent manoeuvrability of the ParaMotion. The joystick control panel also manages the standing function to the driving functions. An electric motor ensures adjustment of the seat from the horizontal position to the upright position. At the same time, the angle of the backrest and the hinges of the leg support are adjusted so that the operator assumes an upright position in the end position. Thanks to the infinitely variable linear motor, any position between the seated position and the standing position can be assumed. All control functions are carried out by means of an R-Net wheelchair control. Thanks to the easy programmability of the R-Net system, the driving functions can be adapted to suit the user's needs.
The ParaMotion device is a stand-up wheelchair. Since this is not an AI/ML device, the typical acceptance criteria related to accuracy metrics are not applicable. Instead, the device's performance is demonstrated through its compliance with various recognized standards for wheelchairs.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Relevant Standards) | Reported Device Performance |
|---|---|
| EN ISO 14971:2012 (Risk Management) | Conforms |
| ISO 7176-1:2014-10 (Static Stability) | Conforms |
| ISO 7176-2:2017-10 (Dynamic Stability) | Conforms |
| ISO 7176-3:2012-12 (Brakes Effectiveness) | Conforms |
| ISO 7176-4:2008-10 (Energy Consumption) | Conforms |
| ISO 7176-5:2008-06 (Dimensions, Mass, Maneuvering Space) | Conforms |
| ISO 7176-6:2018-06 (Max Speed, Acceleration, Deceleration) | Conforms |
| ISO 7176-7:1998-05 (Seating & Wheel Dimensions) | Conforms |
| ISO 7176-8:2014-12 (Static, Impact, Fatigue Strengths) | Conforms |
| ISO 7176-9:2009-11 (Climatic Tests) | Conforms |
| ISO 7176-10:2008-11 (Obstacle-Climbing Ability) | Conforms |
| ISO 7176-11:2012-12 (Test Dummies) | Conforms |
| ISO 7176-13:1989-08-01 (Coefficient of Friction) | Conforms |
| ISO 7176-14:2008-02 (Power & Control Systems) | Conforms |
| ISO 7176-15:1996-11 (Information Disclosure, Documentation, Labeling) | Conforms |
| ISO 7176-16:2012-12 (Resistance to Ignition) | Conforms |
| ISO 7176-21:2009-04 (Electromagnetic Compatibility) | Conforms |
| ISO 7176-22:2014-09 (Set-up Procedures) | Conforms |
| ISO 7176-25:2013-07-15 (Batteries and Chargers) | Conforms |
| ISO 7176-30:2018-12 (Changing Occupant Posture) | Conforms |
| EN 12184:2014 (Non-FDA Recognized Battery Charger Standard) | Conforms |
| DIN EN 61429/A11:2000-01 (Non-FDA Recognized Battery Marking Standard) | Conforms |
| DIN EN 60529:2014-09 (Non-FDA Recognized IP Code Standard) | Conforms |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." Therefore, there is no mention of a "test set" in the context of clinical or performance data from human subjects. The device's performance is assessed against recognized engineering and safety standards using nonclinical (laboratory and bench) testing. The document does not specify the sample sizes (e.g., number of wheelchairs tested) for each specific nonclinical test conducted to ensure compliance with the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set using human data was required, and the evaluation was based on compliance with established technical and safety standards.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was used.
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, as this device is a physical medical device (stand-up wheelchair), not an AI/ML diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device.
7. The type of ground truth used:
For this device, the "ground truth" refers to the established requirements and specifications outlined in the FDA-recognized and non-FDA-recognized international and national standards for wheelchairs. Compliance with these standards (e.g., for stability, braking, speed, safety, risk management, and electromagnetic compatibility) serves as the basis for demonstrating the device's safety and effectiveness.
8. The sample size for the training set:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).