(14 days)
The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor electric scooter that is battery operated. It has a base with three 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 submitted text describes a 510(k) premarket notification for a medical device, the C.T.M. Mobility Scooter HS-235. However, it explicitly states that "Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device" and "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML medical device. This 510(k) relies on demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-120), rather than proving independent performance against acceptance criteria through specific studies.
For the purpose of your request, which implies a study proving performance against acceptance criteria, the provided document does not contain the information requested in points 1-9 because such a study was not conducted or submitted for this 510(k) clearance.
To directly address your points:
- A table of acceptance criteria and the reported device performance: Not applicable. No specific acceptance criteria for performance metrics are defined in the document, nor are performance results reported beyond the general statement of "Tests listed in the Guidance Document... were conducted."
- 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 clinical test set described.
- 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 establishment for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication detailed.
- 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/ML device, and no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth established or used for performance evaluation.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so no training set is described.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device, so no training set or ground truth for it.
Summary based on the provided document:
The C.T.M. Mobility Scooter HS-235 gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-120). This process primarily involved comparing technological characteristics and intended use, and confirming that non-clinical tests specified in relevant guidance documents were conducted. There was no clinical study or performance evaluation against specific acceptance criteria submitted or required for this clearance.
§ 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).