(98 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
The device is mainly composed of painted frame, fireproof and breathable seat cushion, armrest, backrest, hand push tube, detachable leg, 8-inch front wheel, 24-inch rear wheel, brake group and anti-overturn device.
The provided document describes the safety and performance testing for a manual wheelchair and not an AI or imaging device. Therefore, many of the requested fields are not applicable to this submission.
Here's the information that can be extracted and a note for non-applicable fields:
1. A table of acceptance criteria and the reported device performance
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static stability | Meets ISO 7176-1:2014 | Meets ISO 7176-1:2014 |
| Effectiveness of brakes | Meets ISO 7176-3:2012 | Meets ISO 7176-3:2012 |
| Dimensions, mass and maneuvering space | Meets ISO 7176-5:2008 | Meets ISO 7176-5:2008 |
| Seating and wheel dimensions | Meets ISO 7176-7:1998 | Meets ISO 7176-7:1998 |
| Static, impact, and fatigue strengths | Meets ISO 7176-8:2014 | Meets ISO 7176-8:2014 |
| Information disclosure, documentation and Labeling | Meets ISO 7176-15:1996 | Meets ISO 7176-15:1996 |
| Resistance to ignition | Meets ISO 7176-16:2012 | Meets ISO 7176-16:2012 |
| General requirements for wheelchairs | Meets ISO 7176-11:2012 | Tests performed, met requirements |
| Determination of friction of test surface | Meets ISO 7176-13:1989 | Tests performed, met requirements |
| Set-up procedures for wheelchairs | Meets ISO 7176-22:2014 | Tests performed, met requirements |
| Biocompatibility (risk management, cytotoxicity, irritation/hypersensitivity) | Meets ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 | Tests performed, met requirements |
| Usability | User Manual understood and device operability | 15 participants understood the User Manual and operated the device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not explicitly stated for each specific ISO test, but a "Usability Study" was conducted with 15 participants.
- Data provenance: Not specified in the provided text. The manufacturing company is in China, which might suggest where the testing occurred, but it's not explicitly stated for the data provenance. It is a non-clinical/physical performance test, so "retrospective or prospective" is not directly applicable in the same way it would be for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes physical performance testing of a device against international standards, not expert-derived ground truth for an AI system. The "ground truth" here is the adherence to the published ISO standards and internal specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human assessors, not for determining mechanical compliance with ISO standards.
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
This is not applicable. The device is a manual wheelchair, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a manual wheelchair, not an algorithm. Performance tests were conducted on the physical device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests is adherence to international consensus standards (ISO 7176 series and ISO 10993 series) and the manufacturer's internal specifications.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" for a manual wheelchair.
9. How the ground truth for the training set was established
This is not applicable. There is no AI model or "training set" for a manual wheelchair.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).