(41 days)
This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named "Gizmo," which is a mechanical wheelchair. This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it is not an AI/ML medical device submission.
The document explicitly states: "This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users." This indicates that the "Gizmo" device is a simple mechanical device, not a sophisticated diagnostic or AI-powered tool.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML device, as this document is not relevant to such a request.
§ 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).