(96 days)
The intended use of the PF-2 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-2, Four Wheel Electric Scooter
I am sorry, but the provided text from the FDA 510(k) summary for the "Model PF-2, Four Wheel Electric Scooter" does not contain the detailed information about acceptance criteria and a study proving device performance as requested.
The document is a standard FDA 510(k) clearance letter, which primarily states that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device name, regulation number, regulatory class, and indications for use.
It does not provide:
- A table of acceptance criteria or reported device performance.
- Details about a study (sample size, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets, or how ground truth was established).
This type of information is typically found in a more detailed 510(k) summary document or clinical study reports, which are not included in the provided text.
§ 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).