(82 days)
The subject device and the predicate device intended use The subject device and the produced individuals.
Not Found
The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called "Amigo Model 680000 Excite F350".
This document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation. It is a regulatory approval for a physical mobility device (presumably a powered wheelchair or scooter). Therefore, I cannot fulfill your request for information related to AI/ML device studies based on this document.
The information sought in your prompt (e.g., sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typical for the evaluation of AI/ML-driven medical devices. However, this specific document predates the widespread use and regulatory frameworks for such devices and is for a different type of product entirely.
§ 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).