(244 days)
Motorized three-wheeled and four-wheeled battery powered scooters are intended for medical purposes by disabled persons and other non-medical purposes.
Not Found
This is a 510(k) clearance letter for the PaceSaver Espree Scooter, dated July 17, 1997. The document primarily focuses on the regulatory approval of the scooter and explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This type of submission (510(k)) for devices like the PaceSaver Espree Scooter does not typically require the detailed performance studies, acceptance criteria, and ground truth analysis that would be associated with AI/ML-based medical devices or novel technologies. The basis for clearance is demonstrating substantial equivalence to a predicate device, not proving novel clinical effectiveness through extensive studies with acceptance criteria, expert ground truth, or MRMC studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not provided within this document because it is not relevant to a 510(k) clearance for this type of 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).