(78 days)
The C.T.M. Power Chair HS-2800 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person.
The C.T.M. Power Chair HS-2800 is an indoor/outdoor powered wheelchair that is battery operated. It has a base with six wheels, an adjustable padded seat with armrests, and a controller attached to one armrest which allows the rider to control the movement of the chair. It can be disassembled for transport and is provided with an on-board battery charger.
The provided text is a 510(k) summary for a powered wheelchair, the C.T.M. Power Chair HS-2800. This document focuses on demonstrating substantial equivalence to a predicate device (Jazzy Power Chair) under regulatory guidelines. It does not contain information about the development or evaluation of an AI/ML device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, as the document does not describe such a device or study. The sections below will indicate "Not Applicable" or explain why the information is not present in the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Explanation: The document does not specify acceptance criteria or performance metrics in the context of an AI/ML device study. It mentions that "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs" were conducted, but does not detail specific acceptance criteria or performance results from these tests. These tests are likely related to mechanical and electrical safety and functionality of the physical wheelchair, not AI performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not Applicable
- Data Provenance: Not Applicable
Explanation: No test set for an AI/ML device is mentioned. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This suggests the submission relied on the inherent equivalence through design and specified guidance document tests, rather than a clinical performance study involving human subjects or data.
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)
- Number of Experts: Not Applicable
- Qualifications of Experts: Not Applicable
Explanation: Ground truth establishment with experts is not relevant to this device as it is a physical powered wheelchair, not an AI diagnostic or predictive tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable
Explanation: No test set requiring expert adjudication for AI performance is described.
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
- MRMC Study: No
- Effect Size: Not Applicable
Explanation: No MRMC study or AI assistance scenario is described for this powered wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No
Explanation: This document pertains to a physical powered wheelchair, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not Applicable
Explanation: Ground truth for an AI model is not relevant to the described device. The "ground truth" for the wheelchair's performance would be its adherence to mechanical and electrical specifications and safety standards, likely assessed through engineering tests.
8. The sample size for the training set
- Sample Size (Training Set): Not Applicable
Explanation: No training set for an AI/ML device is mentioned.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not Applicable
Explanation: No ground truth for an AI/ML training set is relevant to this device.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).