(37 days)
The intended use of the Medline Strider MINI 4 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 MINI 4 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.
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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Medline Strider MINI 4," which is a motorized three-wheeled vehicle (scooter). This document does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for AI/device performance evaluation.
This letter is a regulatory document confirming that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include details about device performance studies in the way you've requested for AI or diagnostic devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study data, and ground truth from the given text.
This document describes a regulatory clearance process, not a clinical or 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).