(19 days)
The intended use of the Pride Mobility Products Corporation Victory Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities.
The Victory Four 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 regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Victory Four Wheel Scooter is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Victory Four 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.
The provided text describes the regulatory submission for the "Victory Four Wheel Scooter" and primarily focuses on its substantial equivalence to a predicate device, the Pride Mobility SC340 (K930952). The content does not describe a study that involves acceptance criteria, device performance, sample sizes, ground truth from experts, or comparative effectiveness studies in the context of AI/algorithm performance.
Instead, the document details non-clinical testing for compliance with established standards for wheelchairs and scooters. Since the request specifically asks for information related to AI/algorithm performance studies, and this document pertains to a physical medical device (a scooter) and its regulatory approval based on non-clinical testing and predicate device comparison, most of the requested information is not applicable.
Here's a breakdown based on the provided text, highlighting where information is N/A (Not Applicable) or not provided.
Acceptance Criteria and Device Performance (Not Applicable for AI/Algorithm Study)
The document lists compliance with various testing standards for the physical scooter. These are "acceptance criteria" in the sense of regulatory compliance for a physical device, but not in the context of an AI/algorithm performance study.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance / Compliance Status |
|---|---|---|
| Non-Clinical Testing | ANSI/RESNA WC Vol. 1-1998 | Compliant |
| ANSI/RESNA WC Vol. 2-1998 | Compliant | |
| ANSI/RESNA WC Vol. 2-1998 Section 21 (Electromagnetic Compatibility) | Compliant | |
| IEC 60335-2-29 (Battery Chargers) | Compliant | |
| IEC 601-1-1 (Electrical Medical Equipment Safety) | Compliant | |
| CAL 117 (Flammability Testing) | Compliant | |
| Substantial Equivalence | Comparison to Predicate Device (Pride Mobility SC340, K930952) | Considered substantially equivalent based on similar intended use, technological characteristics, components, performance, maneuverability, stability, and structure. Differences (wheelbase, frame construction, control mechanisms) do not raise new safety/effectiveness questions. |
Study Details (Not Applicable for AI/Algorithm Study)
This section is largely N/A as the document explicitly states "N/A" for "Discussion of Clinical Testing Performed" and focuses on non-clinical engineering and design compliance.
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Sample size used for the test set and the data provenance:
- N/A. This device is a physical scooter, not an AI/algorithm. Test sets, in the context of AI, are not relevant here. The "testing" involved physical product performance against engineering standards.
- Data provenance: N/A.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth, in the context of expert review for AI, is not applicable. Regulatory compliance is assessed by adherence to established engineering standards, presumably by qualified engineers/testers.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods for expert consensus on ground truth are not applicable to non-clinical engineering tests.
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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:
- N/A. This is a physical device, not an AI solution designed to "assist human readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (in the AI sense). For this device, "ground truth" would be compliance with objective engineering specifications and safety standards (e.g., a specific torque, speed, stability angle, or flammability resistance measured during testing).
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The sample size for the training set:
- N/A. No AI training set is involved.
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How the ground truth for the training set was established:
- N/A. No AI training set is involved.
§ 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).