(176 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Solax Electric Scooter (Model: S202261B)
This document is a 510(k) clearance letter from the FDA for a medical device called the "Solax Electric Scooter." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a notification that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements that the manufacturer must comply with, such as registration, labeling, and good manufacturing practices.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from this document. This letter pertains to a regulatory clearance, not a technical performance study report.
§ 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).