(53 days)
The C.T.M. Mobility Scooter HS-515 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-515 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It can be disassembled for transport and is provided with an off-board battery charger.
The provided document is a 510(k) summary for the C.T.M. Mobility Scooter HS-515. This type of submission is for medical devices that are mechanical or physical in nature, not AI/software-driven diagnostics or imaging systems. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable to this device and its 510(k) submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in the format typically seen for AI/software performance studies. Instead, the "acceptance criteria" are implied by compliance with established performance tests for mechanical scooters, as outlined in FDA guidance documents.
| Acceptance Criteria Category (Implied by FDA Guidance for Mechanical Scooters) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (demonstrated via comparison to predicate) | "Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness." The device was found "substantially equivalent" to the predicate device (Victory Three Wheel Scooter, Model SC610, K072165) based on regulatory classification, intended use, and similar technological characteristics. |
| Compliance with Performance Standards/Tests | "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission." (The specific results or acceptance thresholds for these tests are not detailed in this 510(k) summary, but their successful completion implies meeting the FDA's expectations for mechanical scooters). |
| Technological Characteristics (similarity to predicate) | Very similar to the predicate: battery-operated, one motor, automatic braking systems, off-board battery chargers, can be disassembled for transport. Target population and use parameters are identical/similar. (Difference noted: controllers are different, but this was not deemed to raise new safety/effectiveness questions). |
Study Information (as applicable to this device type)
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Sample size used for the test set and the data provenance:
- N/A. This is a mechanical device. Performance testing involved physical tests on the scooter itself, not a "test set" in the data-driven sense. The document does not specify the number of units tested.
- Data provenance: The tests were "conducted and the results included in the submission." The country of origin for the testing is not specified, but the applicant is C.T.M. Homecare Product, Inc. in Chino, CA, and the contact is in Eugene, OR.
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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 for a mechanical scooter primarily involves meeting engineering and safety specifications, which are assessed through direct physical testing and measurement, not expert review of data/images. The "ground truth" is adherence to established mechanical and electrical safety standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert readings in diagnostic AI/software studies. This is not relevant for a mechanical scooter.
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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 mechanical mobility scooter, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm" in the context of AI/software performance. It is a physical product.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a mechanical device like a scooter, the "ground truth" for performance is based on objective measurements from engineering tests and compliance with established performance standards and safety regulations (e.g., stability, braking effectiveness, speed, battery life, weight capacity). The summary states that "Tests listed in the Guidance Document... were conducted."
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The sample size for the training set:
- N/A. This is a mechanical device, not an AI/software. There is no "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
§ 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).