(261 days)
The Mobility Scooter (Model: JT10) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter, Model JT10 is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with steel frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-acid batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed knob and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
The provided FDA 510(k) clearance letter for the Mobility Scooter (JT10) does not contain information related to an AI/ML-driven device or diagnostic study. Instead, it discusses the substantial equivalence of a physical medical device (mobility scooter) to a predicate device, based on engineering aspects and performance standards.
Therefore, I cannot extract the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are specifically applicable to the evaluation of AI/ML or diagnostic devices. The document focuses on physical and functional comparisons and adherence to relevant ISO standards for wheelchairs and mobility aids.
Essentially, the device cleared here is a mobility scooter, not a software or AI-based diagnostic tool. As such, the performance evaluation relies on physical testing against established ISO standards for mobility devices, not on data analysis of images or other medical data.
§ 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).