(70 days)
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor Mobility Scooter that is battery operated. It has a base with four wheels and a lightweight adjustable seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an off board battery charger.
The provided text is a 510(k) summary for the C.T.M. Mobility Scooter HS-118. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a study in the way a medical diagnostic AI device might.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, specific types of ground truth) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the provided text, tailored to the context of this device:
Acceptance Criteria and Study for C.T.M. Mobility Scooter HS-118
The C.T.M. Mobility Scooter HS-118 sought 510(k) clearance by demonstrating "substantial equivalence" to predicate devices, namely the Go-Go Ultra X (K063389) and VCS S3T (K051131). The primary "acceptance criteria" were met by showing that its technological characteristics, intended use, and performance data were comparable to these predicates, and that any differences did not raise new questions of safety or effectiveness.
1. Table of "Acceptance Criteria" and Reported Device Performance
| Acceptance Criteria Category (Implied by 510(k) Equivalence) | Reported Device Performance (HS-118) |
|---|---|
| Intended Use | Indoor/outdoor transportation for disabled or elderly persons. |
| Regulatory Classification | Class II, Product Code INI (Motorized three-wheeled vehicle, 21 CFR 890.3800) |
| Technological Characteristics | Battery operated, one motor, automatic braking system, off-board charger, disassembled for transport. |
| Key Components | Uses the same controller (STAR 70-Z controller) as the VCS S3T predicate. |
| Safety and Effectiveness | "Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness." |
| Performance Testing | 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. Results were included in the submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This was a submission for a physical device, not an AI/diagnostic algorithm tested on a dataset of patient samples. The "test set" in this context refers to bench testing of the scooter itself.
- Data Provenance: Not applicable in the traditional sense of clinical data. The "data" comes from bench testing of the physical scooter and comparison of its specifications to predicate devices. The country of origin for the data generation would be where C.T.M. Homecare Product, Inc. conducted its testing, likely in China or the US given the company's address and contact. The testing was prospective in the sense that it was performed on the device being submitted for clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for a mechanical device like a scooter is its physical performance against established engineering and safety standards. There isn't a concept of expert consensus for labeling a case as positive or negative.
- Qualifications of Experts: Not applicable. Testing would have been conducted by engineers or technicians familiar with relevant standards (e.g., ISO, ANSI, FDA guidance).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There's no "test set" of cases requiring adjudication by multiple readers or experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." MRMC studies are typically used for diagnostic devices to assess human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "bench testing," the ground truth corresponds to accepted engineering specifications and safety standards outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995." Compliance with these predetermined thresholds and successful completion of the specified tests served as the "ground truth" for the device's functional and safety performance.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no AI algorithm being "trained" in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: 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).