(10 days)
The intended use is to provide mobility to persons limited to a seated position.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a power wheelchair. It does NOT contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or any of the other AI/algorithm-related questions you've asked. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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).