(112 days)
"Provides mobility for the disabled".
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Solo" (and "Safari scooters"). It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
The letter is a regulatory approval, not a scientific study report. It simply states the device's intended use: "Provides mobility for the disabled."
Therefore, based only on the provided input, I cannot answer the questions about acceptance criteria, study details, or performance.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).