(11 days)
The intended use of the Pride Mobility Products Corporation Victory Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
The Victory Three Wheel Scooter is a mid-size battery-operated scooter having a programmable 70-amp Digital Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic reqenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Three Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers. The Victory Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is a narrow wheelbase (22"), which allows better maneuverability from a mid-sized product.
This document is a 510(k) premarket notification for a medical device, specifically a Victory Three Wheel Scooter. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a new, AI-driven diagnostic or therapeutic device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not applicable to this document as it is a submission for a durable medical equipment (DME) device, not a diagnostic or AI-enabled device requiring such detailed performance evaluation against clinical endpoints.
The document states:
- "Discussion of Clinical Testing Performed: N/A"
- "The nonclinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
This indicates that clinical testing, in the sense of a performance study with human subjects, was not performed or deemed necessary for this 510(k) submission. Instead, the submission relies on non-clinical testing against established industry standards and comparison to a legally marketed predicate device.
To directly address your request given the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC Vol. 1-1998 Requirements and Test Methods for Wheelchairs (Including Scooters) | Device has passed all testing requirements and is considered safe for user operation. |
| ANSI/RESNA WC Vol. 2-1998 Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems | Device has passed all testing requirements and is considered safe for user operation. |
| ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. | Device has passed all testing requirements and is considered safe for user operation. |
| IEC 60335-2-29 Safety of Electrical Appliances (Part 2 Battery Chargers) | Device has passed all testing requirements and is considered safe for user operation. |
| IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety | Device has passed all testing requirements and is considered safe for user operation. |
| CAL 117 - Flammability Testing | Device has passed all testing requirements and is considered safe for user operation. |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to non-clinical testing against standards for the device itself, not a test set of data like in an AI/diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of device is compliance with engineering and safety standards, as well as functional equivalence to a predicate device, rather than a clinical ground truth.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.
§ 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).