(121 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 Mobility Scooter, Model: W3431, has a base with Steal frame, two front wheels, a seat, a tiller console, 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 control dial 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 document is a 510(k) Premarket Notification for a Mobility Scooter (Model W3431). This document assesses the substantial equivalence of the new device to a predicate device, primarily through non-clinical testing and comparison to established industry standards. Critically, it does not contain information related to a study involving acceptance criteria for an AI/ML device as it pertains to human-in-the-loop performance, algorithmic standalone performance, or the use of expert consensus for ground truth. The device in question is a physical mobility scooter, not an AI/ML-based medical device.
Therefore, I cannot fulfill your request for information on acceptance criteria and study details for an AI/ML device based on the provided text. The document specifically states:
- "No clinical study is included in this submission." (Page 6, Section G)
- The non-clinical tests were conducted to verify that the proposed device met design specifications and was "Substantially Equivalent (SE) to the predicate device." (Page 6, Section F)
The tables presented (Tables 1, 2, and 3) are comparisons between the proposed mobility scooter and its predicate device across various physical and performance characteristics, adhering to ISO 7176 series standards for wheelchairs. These standards cover aspects like static stability, dynamic stability, effectiveness of brakes, energy consumption, dimensions, maximum speed, obstacle-climbing ability, biocompatibility, and electromagnetic compatibility.
To answer your prompt, I would need a document related to the submission or evaluation of an AI/ML medical device.
§ 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).