(41 days)
The Cougar Wheelchair's intended function and use is to provide mobility to persons limited to a sitting position.
The wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front pivoting casters for steering and turning.
This looks like a 510(k) clearance letter from the FDA for a mechanical wheelchair, not a document describing an AI/ML medical device. Therefore, the questions about acceptance criteria, study details, ground truth, and training data are not applicable to this document.
The document states:
- Trade/Device Name: Cougar Wheelchair
- Regulation Number: 21 CFR 890.3850
- Regulation Name: Mechanical wheelchair
- Regulatory Class: I
- Product Code: IOR
This device is a mechanical wheelchair, which falls under Class I (general controls) and does not involve AI or algorithms. The FDA's determination is based on substantial equivalence to legally marketed predicate devices, not on a performance study against specific acceptance criteria in the manner you've described for AI/ML products.
§ 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).