(123 days)
It 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 subject device, Model HS186B Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller, a control panel, an electric motor, an electromagnetic brake, a rechargeable Lithium-lon Battery with a charger. The movement of the scooter is controlled by the rider who operates the throttle Control Lever, speed knob and hand grips. 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 is suitable for use indoors and on flat roads near buildings.
The provided text is a 510(k) summary for a medical device (HS186B Scooter) and an FDA clearance letter. It details a comparison between the proposed device and a predicate device, focusing on non-clinical testing and safety features to demonstrate substantial equivalence. However, it does not describe acceptance criteria for an AI device or a study involving AI performance metrics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI device.
- Sample size used for the test set and data provenance for an AI device.
- Number of experts and their qualifications for establishing ground truth for an AI test set.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study results (AI improvement vs. without AI assistance).
- Standalone AI performance.
- Type of ground truth used for AI.
- Sample size for AI training set.
- How ground truth for AI training set was established.
This document pertains to a physical medical device (a motorized scooter) and its performance is evaluated against ISO standards and through comparison with a predicate device, not through AI-specific metrics. The "Non-Clinical Testing" section describes adherence to various ISO standards relevant to wheelchairs and scooters, and a "Biocompatibility" assessment. The document explicitly states "No clinical study implemented for the scooter." It does not mention any AI components or related studies.
§ 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).