(29 days)
The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and has an on-board battery charger.
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary for the C.T.M. Mobility Scooter HS-310 explicitly states:
"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
This indicates that the submission did not include a study designed to evaluate the device's performance against specific acceptance criteria. The clearance was based on substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-320) due to similar technological characteristics and intended use, rather than a direct performance study of the HS-310 itself.
Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, ground truth, experts, adjudication, MRMC studies, or standalone performance.
§ 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).