(25 days)
The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.
Not Found
This is a medical device marketing authorization from the FDA for a powered wheelchair, the "Scout Boss." It is not a study describing a device that uses AI/ML or an algorithm-based diagnostic. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document.
This document is a 510(k) clearance letter, which means the device (a powered wheelchair) was found to be "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often through engineering tests and comparisons rather than clinical studies in the context of diagnostic accuracy.
Therefore, I cannot provide the requested information as it is not present in 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).