(28 days)
The C.T.M. Mobility Scooter HS-265 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-265 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 which allow the rider to control the movement of the scooter. It can be disassembled for transport and is provided with an on-board battery charger.
Here's an analysis of the provided 510(k) summary regarding the C.T.M. Mobility Scooter HS-265, focusing on acceptance criteria and study details:
This document describes a mobility scooter, which is a physical device, not an AI/ML device. Therefore, the majority of the questions related to AI/ML device testing (e.g., sample size for test sets, ground truth, experts, MRMC studies, standalone performance, training set) are not applicable to this submission.
The 510(k) summary explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that the regulatory pathway relied on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-235 cleared under K032918) through technological characteristics and adherence to recognized guidance documents, rather than independent performance studies with acceptance criteria in the typical sense for AI/ML or efficacy studies.
However, I can extract the information that is present and indicate where information is missing or not applicable based on the nature of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Adherence to "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995" | "Tests listed in the Guidance Document... were conducted and the results included in the submission." | The specific performance metrics and their acceptance thresholds from the guidance document are not detailed in this summary. The summary only states that the tests were conducted and the results were submitted to the FDA. |
| Substantial Equivalence to Predicate Device (C.T.M. Mobility Scooter HS-235, K032918) | The device features of the HS-265 and HS-235 are "very similar." Both are battery operated, have one motor, automatic braking, and can be disassembled. Target population and use parameters are "identical and similar." | This is the primary "acceptance criterion" for a 510(k) pathway, demonstrating that the new device is as safe and effective as a legally marketed predicate. |
For the following questions, please note that they are largely not applicable to this type of device submission (a physical mobility scooter) and the regulatory pathway chosen (510(k) based on substantial equivalence to a predicate without new clinical or comparative performance studies beyond adherence to guidance documents).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A). No specific "test set" in the context of AI/ML or comparative clinical performance was described. The testing mentioned refers to engineering/performance tests as outlined in a guidance document, not data-driven evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable (N/A). Ground truth and expert consensus are irrelevant for device performance testing of a mobility scooter. The "ground truth" for a mobility scooter's safety/performance would be adherence to engineering specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A). Adjudication methods are used in clinical trials or expert label review for data, which is not described here.
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 (N/A). This is a mobility scooter, not a diagnostic AI/ML device. Therefore, MRMC studies and "human readers" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (N/A). No ground truth in the context of data labeling or clinical outcomes was used for this type of submission. The "ground truth" for device performance would be physical measurements against engineering specifications and safety standards.
8. The sample size for the training set
- Not Applicable (N/A). There is no "training set" as this is a physical product, not an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable (N/A). As there is no training set, this question is not relevant.
§ 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).