(65 days)
The C.T.M. Mobility Scooter HS-360 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.
The C.T.M. Mobility Scooter HS-360 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.
1. Table of acceptance criteria and reported device performance:
The provided document, K012792, is for a C.T.M. Mobility Scooter HS-360. This type of device is a motorized three-wheeled vehicle, Class II, 21 CFR 890.3800. The 510(k) summary states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." The acceptance for this device was based on substantial equivalence to a legally marketed predicate device (Sunrunner TE-777-4, K923193) and adherence to tests listed in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995."
Therefore, there is no explicit table of acceptance criteria with corresponding device performance metrics in the provided text. The acceptance criterion was primarily demonstrating substantial equivalence to a predicate device and complying with general guidance documents rather than specific quantitative performance targets.
2. Sample size used for the test set and the data provenance:
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned because "Comparative performance testing and clinical evaluations were not submitted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No experts were used to establish ground truth for a test set, as no such testing was performed or submitted.
4. Adjudication method for the test set:
Not applicable, as no test set requiring ground truth adjudication was submitted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
Not applicable. This is a medical device (mobility scooter), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical, battery-operated mobility scooter, not an algorithm.
7. The type of ground truth used:
Not applicable. No ground truth was established through expert consensus, pathology, or outcomes data because "Comparative performance testing and clinical evaluations were not submitted." The "ground truth" for this submission was implicitly the established safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning 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).