(78 days)
The intended use of the PF-3 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
Model PF-3, Four Wheel Electric Scooter
This document is a 510(k) premarket notification letter from the FDA regarding a motorized four-wheel power scooter (PF-3). It confirms substantial equivalence to a legally marketed predicate device.
The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It is a regulatory approval letter, not a scientific study report.
Therefore, I cannot fulfill your request for the specific information about acceptance criteria and the study proving the device meets them based on the given input.
§ 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).