(32 days)
The intended use of the Medline Strider MAXI 3 scooter is to provide mobility to persons that have difficulty walking for prolonged periods of time. They are intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.
The Medline Strider MAXI 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and arcas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a motorized three-wheeled vehicle (scooter). It does not contain information about the acceptance criteria, study details, or performance of a device in the context of an AI/medical imaging study.
Therefore, I cannot extract the requested information about acceptance criteria, study design, expert ground truth, or AI performance. The document pertains to the regulatory clearance of a physical medical device (a scooter), not a diagnostic algorithm or image analysis software.
§ 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).