(51 days)
To provide an optional means of mobility for physically challenged people.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Little Coach," which is a motorized three-wheeled vehicle. This type of document does not contain the information requested regarding acceptance criteria studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the FDA has cleared the device based on its substantial equivalence to a predicate device, not necessarily on a detailed study demonstrating its performance against specific acceptance criteria in the manner one might find for a novel or high-risk device requiring comprehensive clinical trials.
Therefore, I cannot extract the requested information from 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).