(60 days)
The C.T.M. Mobility Scooter HS-686 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-686 is an indoor/outdoor four-wheeled scooter which is battery operated. It consists of a platform which connects the four wheels, an adjustable steering column, and a seat for the rider. The rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.
The provided 510(k) summary for the C.T.M. Mobility Scooter HS-686 does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document states: "Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This explicitly indicates that the type of study you're asking for was not conducted or submitted for this specific device clearance.
Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).
The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Shoprider The TE889) based on intended use, technological characteristics, and conformance to general guidance documents rather than specific performance metrics and extensive clinical or performance studies. The "Testing conducted" section vaguely refers to "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," but does not provide the results or specific acceptance criteria for these tests within 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).