(195 days)
Provides mobility for the disabled.
Not Found
The provided documents are a 510(k) clearance letter from the FDA for a device named "Safari," described as a scooter providing mobility for the disabled. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the documents do not contain any information regarding:
- Acceptance criteria
- Reported device performance
- Specific studies conducted
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established
The letter is a regulatory approval document and not a clinical study report or a technical performance specification. Therefore, I cannot fulfill your request with the input provided.
§ 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).