(272 days)
The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
There are three models in the Quingo range for this subject 510(k): Quingo Flyte Power Scooter, S551 (transportable model), Quingo Classic Power Scooter, S1301 and Quingo Toura Power Scooter, S350 (pavement and higher speed models). They all have very similar characteristics which are detailed below, with the main differences being: length, widths, motor size, controller size, and wheel size. All the Quingo models scooter frames are a welded steel construction and they all include 2 rear wheels connected by a motor/ transaxle with an electromagnetic brake, batteries, and they all have 3 front wheels and a tiller to control its turning direction. When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooters are allowed to move forwards or backward. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The electromechanical brakes allow the user to stop by letting to of the throttle lever. All the Quingo Models have an emergency parking brake, the lever for this brake is on the tiller and the brake itself is a carbon disc brake on to the front middle wheel.
The provided document is a 510(k) summary for a medical device, specifically power scooters. It does not contain information about an AI/ML-driven medical device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance standards and comparisons of specifications.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves an AI/ML device meets acceptance criteria based on the provided text. The document discusses:
- Device Description: Power scooters (Quingo Classic, Flyte, Toura).
- Predicate Device: Merits Transformer, Model S941, K142162.
- Comparison Tables: Detailed comparisons of physical, electrical, and performance characteristics between the subject devices and the predicate device.
- Non-Clinical Tests: Adherence to various ISO, ANSI, BS EN, and IEC standards for wheelchairs and motorized three-wheeled vehicles (e.g., static stability, dynamic stability, brakes, energy consumption, dimensions, speed, strength, climatic tests, electromagnetic compatibility, ignition resistance).
- Clinical Tests: Stated as "Not applicable as there are no new indications for use which must be supported by a clinical data."
- Software Information: Mentions "Software validation was conducted in accordance with a major level of concern designation" but provides no details on the validation study itself.
None of this information pertains to the rigorous evaluation of an AI/ML device's performance against defined acceptance criteria, including aspects like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies for human-AI interaction.
§ 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).