(97 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Not Found
This document is a marketing authorization for a power wheelchair, not a study evaluating an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and performance metrics related to AI/ML device evaluation cannot be extracted from this text.
The document discusses regulatory compliance for a power wheelchair, including:
- Trade/Device Name: Power wheelchair
- Regulation Number/Name: 21 CFR 890.3860, Powered Wheelchair
- Regulatory Class: Class II
- Product Code: ITI
- Indications for Use: "It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."
- Type of Use: Over-The-Counter Use
It does not contain any information about:
- Acceptance criteria or reported device performance in the context of AI/ML.
- Sample sizes, data provenance, or details about a test set.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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).