(100 days)
The Freerider Model FR510-F is a motorized scooter which provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
The Freerider Model FR510-F is a motorized four-wheeled scooter which is battery operated. It consists of a platform which connects the four wheels, an adjustable tiller, and a seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be disassembled into five parts for transport in a car trunk. It is provided with a battery charger.
The provided document, K971387, describes the 510(k) submission for the Freerider™ FR510-F Electric scooter. However, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, the following information regarding acceptance criteria and performance evaluation against those criteria cannot be extracted from this document, as such studies were not performed or submitted.
Here's a breakdown of what can be said based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states "Comparative performance testing and clinical evaluations were not submitted." The manufacturer conducted "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," but the specific acceptance criteria and the quantitative results are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Cannot provide. No specific test set or clinical data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set requiring expert ground truth was submitted.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was submitted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- No. The document explicitly states "Comparative performance testing and clinical evaluations were not submitted."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a motorized scooter, not an AI/algorithm-based diagnostic or prognostic tool. The concept of "standalone performance" for an algorithm does not apply.
7. The type of ground truth used
- Not applicable. No performance studies requiring ground truth were submitted.
8. The sample size for the training set
- Not applicable. This device is a motorized scooter; it does not involve machine learning or a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was utilized for this type of device.
Summary based on the provided text:
The 510(k) submission for the Freerider™ FR510-F Electric scooter relied on demonstrating substantial equivalence to a predicate device (Shoprider 114 -TE889) based on technological characteristics and adherence to guidance document testing for mechanical and powered wheelchairs/motorized three-wheeled vehicles. Specific performance testing or clinical evaluations were not submitted with this 510(k). The FDA's clearance indicates that based on this information, the device was deemed substantially equivalent for its intended use as described.
§ 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).