(60 days)
The mobility scooter 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.
This mobility scooter 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 N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. 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 text is a 510(k) Summary for a Mobility Scooter (N3473), a medical device. It does not contain information about an AI/ML-driven medical device.
Therefore, I cannot provide information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, number of experts, adjudication methods for training or test sets in the context of AI/ML.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used for AI/ML.
- How ground truth for training sets was established for AI/ML.
The document discusses the non-clinical testing performed for a physical device (mobility scooter) to demonstrate its substantial equivalence to a predicate device. This testing primarily involves adherence to ISO 7176 series standards related to wheelchairs and scooters, covering aspects like stability, brakes, speed, dimensions, strength, climatic tests, obstacle climbing, power/control systems, and electromagnetic compatibility.
Here's what can be extracted from the document regarding the mobility scooter's acceptance criteria and study:
1. Acceptance Criteria and Reported Device Performance (Non-AI Device)
The general acceptance criteria are that the subject device's performance meets the relevant ISO standards and exhibits no deleterious effect on safety and effectiveness compared to the predicate device, despite minor differences. The document asserts that "All test results meet the requirements" of the specified ISO standards for the subject device.
Here's a table based on the explicit comparisons provided, specifically focusing on measurable performance attributes mentioned in the "Comparison with the predicate device" section. While a direct "acceptance criterion" value isn't always given, the "Result" column implies acceptance if "Same" or if the difference is deemed non-deleterious after testing.
| Acceptance Criterion (implicitly met by matching predicate or standard) | Reported Subject Device Performance | Predicate Device Performance | Result (from document) | Notes |
|---|---|---|---|---|
| Time to brake |
§ 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).