(23 days)
The C.T.M. Mobility Scooter HS-250 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-250 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with a lightweight seat, armrests, and a front basket. 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 onboard battery charger.
The provided 510(k) summary for the C.T.M. Mobility Scooter HS-250 does not include a table of acceptance criteria, detailed device performance, or a study proving that the device meets specific acceptance criteria in the way described for typical AI/ML medical devices.
Instead, this submission is for a physical medical device (a mobility scooter) and relies on a demonstration of substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-360) rather than a performance study against predefined acceptance criteria.
Here's an analysis based on the information provided, highlighting why a direct answer to your request is not possible with this type of document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics in the context of an AI/ML device. For this physical device, the "acceptance criteria" are implied by showing the device's technological characteristics are "very similar" to the predicate device and that it meets the "Intended Use" (providing transportation for disabled/elderly persons). The testing conducted refers generally to "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," but specific performance targets or thresholds from that document are not detailed in this summary.
- Reported Device Performance:
- Braking distance at maximum speed: 4.67 feet
- Minimum turning radius: approximately 35.4 inches
- Forward speed range: 0-4.1 mph
- Reverse speed range: 0-1.5 mph
- Heaviest single component: 27.7 pounds
- Total weight with batteries: approximately 107 pounds
- Motor: 250 watt, 3800 rpm
- Batteries: two 12-volt 12Ah batteries
- Battery Charger: 24-volt constant current charger, plugs into 110V or 220V socket.
- Self-diagnostic signals: 9 distinct codes for problems like battery, motor, or brake malfunctions.
The document does not state how these performance metrics were tested or what thresholds they had to meet. They are presented as characteristics of the device.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a physical device, and the "testing" involved verifying its mechanical and electrical characteristics, likely in a laboratory or engineering testing environment, rather than a clinical study with a "test set" of patient data.
- Data Provenance: Not applicable for a typical AI/ML "test set." The testing was likely internal by the manufacturer following industry guidance for mobility devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of AI/ML, refers to validated data labels. For this physical device, "ground truth" would relate to engineering specifications and safety standards, which are typically established by engineers and regulatory bodies, not clinical experts for "ground truth labeling."
4. Adjudication method for the test set
- Not applicable. There is no mention of "adjudication" as would be performed in a clinical study for an AI/ML device.
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
- No background document in the input indicates a MRMC study. This is a physical mobility device and does not involve "human readers" or "AI assistance" in the sense of an AI/ML diagnostic or predictive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No background document in the input indicates standalone performance. This is not an AI/ML algorithm.
7. The type of ground truth used
- Not applicable in the AI/ML sense. For this device, "ground truth" implicitly relates to engineering specifications, safety standards, and functional requirements for mobility scooters. For example, the braking distance being 4.67 feet is a measured characteristic against an engineering design, not a clinical pathology or outcome.
8. The sample size for the training set
- Not applicable. There is no AI/ML model for which to describe a "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model for which to describe a "training set" or its ground truth establishment.
In summary: The provided 510(k) pertains to a physical medical device (mobility scooter) and therefore does not contain the information requested for an AI/ML device's acceptance criteria and study data. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device, supported by engineering tests rather than clinical performance studies with "test sets" or "training sets" in the context of AI/ML. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
§ 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).