(9 days)
The intended use of the Pride Mobility Products Corporation V Series Scooters is to provide mobility to disabled persons having limited walking capabilities.
The V Series Scooters are three and four wheeled battery-operated scooters. Features include a programmable controller, removable seat, a foldable tiller, two piece frame, and an off board charger; specific models include a Power Seat actuator. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Scooters can be disassembled into four parts: the rear section, the front section, batteries, and the seat; this allows for ease of use when traveling or storing the unit.
The V Series Scooters are designed with ultimate safety, stability, and performance in mind and are designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
This document describes a 510(k) premarket notification for Pride Mobility Products Corporation's V Series Scooters. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available within this document. This submission relies on non-clinical testing and comparison to predicate devices to establish safety and effectiveness.
Here's a breakdown of what can be extracted from the provided text, and where your requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable for this type of submission. A 510(k) generally does not present a table of specific acceptance criteria with corresponding performance statistics in the way a clinical trial might. The "performance" is implicitly demonstrated through compliance with standards and comparison to a predicate device.
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not describe a clinical "test set" with human or AI performance data. The "testing" mentioned is non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" with expert-established ground truth described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No such adjudication method is mentioned for this type of non-clinical testing.
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:
- No, an MRMC study was not done. This device is a mobility scooter, not a diagnostic AI system, therefore such a study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mobility scooter, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. There is no "ground truth" established in the context of clinical data for performance evaluation in this submission. Safety and effectiveness are demonstrated through compliance with engineering standards and substantial equivalence to existing devices.
8. The sample size for the training set:
- Not applicable. This is a hardware device (scooter), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
What is available regarding testing and performance:
The document states:
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Non-Clinical Testing: Compliance to applicable Testing Standards is as follows:
- RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
- RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
- ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
- IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety
- CAL 117 - Flammability Testing
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Discussion of Clinical Testing Performed: N/A (Not Applicable)
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Comparison to Predicate Devices: "The V Series Scooters are substantially equivalent to the Pride Mobility, Victory Three Wheel Scooter (K072165) and the Victory Four Wheel Scooter (K071949) when comparing, performance, maneuverability, stability, and structure."
Conclusion:
The V Series Scooters demonstrated substantial equivalence to predicate devices (Pride Mobility, Victory Three Wheel Scooter K072165 and Victory Four Wheel Scooter K071949) based on non-clinical testing and comparison of performance, maneuverability, stability, and structure. The non-clinical testing indicated compliance with several RESNA, ANSI/RESNA, IEC, and CAL flammability standards. No clinical testing or AI-specific performance evaluation with acceptance criteria, ground truth, or expert review was performed or reported in this 510(k) submission.
§ 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).