(53 days)
The intended use of the eLexus(MP3C-1) is to provide mobility to persons limited to a seated position t are capable of operating a powered wheelchair.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Primechair" (later referred to as eLexus(MP3C-1)), a powered wheelchair. It is a regulatory approval document and not a scientific study report. Therefore, it does not contain information about acceptance criteria for an AI/device's performance or a study proving that the device meets such criteria in the way you've outlined.
The information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in clinical study reports or scientific publications for AI/medical device performance evaluation, not in 510(k) clearance letters for powered wheelchairs.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance characteristics evaluated in the context you're asking about for AI systems.
Therefore, I cannot extract the requested information from the provided text.
§ 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).