(123 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Not Found
This document is a marketing clearance letter from the FDA for a device called "Wu's Three-Wheeled Neo Scooter, WT-M4" (though the Indications for Use refers to it as "Wu's 4-Wheeled Neo Scooter, WT-M4"). This is a physical medical device, specifically a motorized three-wheeled vehicle intended to provide mobility to persons restricted to a seated position.
The request asks for information relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device. This document does not contain any information about acceptance criteria or studies related to AI or algorithms. Instead, it is a statement of substantial equivalence to predicate devices for a physical product based on the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
Therefore, I cannot provide the requested information from the given text as it is not applicable to the type of device described in the prompt.
§ 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).