(83 days)
The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Electric wheelchair (W3902)
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric wheelchair (W3902)". This document does not contain information about the acceptance criteria and study details for an AI/ML device. It focuses on regulatory approval based on substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
§ 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).