(60 days)
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-666 is an indoor/outdoor three-wheeled scooter which is battery operated. It consists of a platform which connects the wheels, an adjustable steering column, and a seat for the rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.
The provided document is a 510(k) premarket notification for a medical device (CTM Mobility Scooter HS-666), not a study report. As such, it does not contain the detailed information typically found in a study or clinical trial report regarding acceptance criteria and performance against those criteria. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the subsequent questions related to study design, ground truth, or expert involvement.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. The relevant "acceptance criteria" here are the requirements 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." The device aims to demonstrate substantial equivalence to a predicate device.
- Reported Device Performance: The document describes the device's technical characteristics and how they compare to a predicate device. The performance details are descriptive rather than quantitative from a formal study.
| Performance Metric | Stated Performance (for C.T.M. Mobility Scooter HS-666) | Comparison to Predicate (Shoprider TE889) |
|---|---|---|
| Battery operated | Yes | Same |
| Motor horsepower | Less than 1 horsepower | Same |
| Automatic braking system | Yes | Same |
| Battery type | Two 12 volt SLA (sealed lead acid) or gel cell batteries | Similar |
| Battery charger | 24-volt constant current charger, 110V/220V compatible | Similar |
| Disassembly for transport | Into five parts, heaviest 57.5 lbs | Not explicitly compared but implied similar functionality |
| Rider capacity | One person | Same |
| Minimum turning radius | 100 cm | Not explicitly compared |
| Maximum forward speed (flat surface) | 5.5 mph | Very similar, varying only in minor parameters (e.g., curb climbability) |
| Maximum reverse speed | 2.2 mph | Not explicitly compared |
| Forward speed (turtle mode) | 2.2 mph | Not explicitly compared |
| Reverse speed (turtle mode) | 0 mph | Not explicitly compared |
| Braking time | Less than 1 second | Not explicitly compared |
| Braking distance | Less than 1 meter | Not explicitly compared |
| Braking system default | Brakes "on" if electrical system fails | Not explicitly compared |
| Free-wheeling mode | Yes (lever from "D" to "N") | Not explicitly compared |
| Self-diagnostic warnings (examples) | 1 flash: battery needs recharging | Not explicitly compared |
| 2 flashes: dead battery | ||
| 3 flashes: battery overcharge |
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. No performance or clinical test set was submitted or described. The testing conducted primarily refers to compliance with a "Guidance Document," implying engineering and design verification rather than a clinical study.
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. No ground truth was established for a test set in the context of a clinical or performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used requiring adjudication.
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 is not an AI-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but a physical mobility device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no clinical or performance study was conducted in the manner of diagnostic or treatment efficacy evaluation. The "ground truth" for this submission is substantial equivalence to the predicate device based on technical characteristics and intended use.
8. The sample size for the training set
- Not applicable. This is not a machine learning device; therefore, no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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).