(65 days)
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.
The provided 510(k) summary for the C.T.M. Mobility Scooter HS-320 does not contain acceptance criteria or a detailed study proving the device meets such criteria in the way typically expected for medical devices involving diagnostic performance or clinical outcomes. Instead, it focuses on substantial equivalence to a predicate device based on technological characteristics and general safety testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As stated, no explicit acceptance criteria with quantitative thresholds are provided in the document. The submission relies on demonstrating similarity to a legally marketed predicate device (Sunrunner TE-777-3). The "performance" mentioned refers to general device features and safety tests rather than diagnostic accuracy or clinical effectiveness.
Therefore, a table cannot be constructed as requested.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size: Not applicable. The submission states, "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that no specific test set of users or data for comparative performance was used.
- Data Provenance: Not applicable for comparative performance testing. The "Testing conducted" refers to general safety and design verification tests listed in a guidance document, but details on sample size or provenance for these tests are not provided and are not related to clinical or diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical or comparative performance test set was used, and thus no ground truth establishment by experts for such a set was performed or reported.
4. Adjudication Method for the Test Set
Not applicable. No clinical or comparative performance test set was used, and thus no adjudication method was employed.
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 device is a mobility scooter, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC study or assessment of AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical mobility scooter, not an algorithm or software-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic or clinical performance. The "ground truth" for this device's safety and functionality would implicitly be established by engineering standards and internal testing to ensure the scooter operates as intended and meets safety specifications (e.g., braking performance, stability, battery life). The document mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," which implies that the ground truth for these tests is defined by the standards and methodologies within that guidance document.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML or a diagnostic device that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set was used.
Summary of the Device's "Acceptance" Basis from the Provided Text:
The C.T.M. Mobility Scooter HS-320 received 510(k) clearance based on substantial equivalence to a previously marketed predicate device (Sunrunner TE-777-3). The primary arguments for substantial equivalence are:
- Similar Intended Use: Both are indoor/outdoor scooters for disabled or elderly persons.
- Similar Technological Characteristics: Both are battery-operated electric scooters with three wheels, adjustable seating, hand controls, and automatic braking systems.
- Performance Differences: The document acknowledges "varying only slightly with selected parameters, such as with the maximum distance that each scooter can be driven," implying these slight variations were not deemed significant enough to warrant a finding of non-equivalence.
- Conformance to Guidance Document: Tests outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995" were conducted. While the specific results or acceptance criteria for these tests are not detailed in the summary, their completion contributes to the overall demonstration of safety and effectiveness consistent with the predicate.
Crucially, the submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This reinforces that the clearance was not based on demonstrating superior or even equivalent performance in a clinical study sense, but rather on the similarity of design, function, and intended use as well as compliance with recognized safety standards for this class of device.
§ 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).