(23 days)
The intended use of the Medline Excel Recliner Wheelchair is to provide mobility to persons limited to a sitting position but unable to sit in an upright position for long periods of time.
Medline Excel Recliner Wheelchair
This document is a 510(k) clearance letter from the FDA for a mechanical wheelchair, not a device that would typically have acceptance criteria and performance studies in the way you've described for an AI/medical imaging product.
The provided text does not contain any information about:
- Acceptance criteria tables or reported device performance for an AI/imaging device.
- Sample sizes for test sets, data provenance, or the number of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how ground truth was established for training sets.
This document is solely focused on the FDA's determination of substantial equivalence for a physical product (a wheelchair) to pre-amendment devices, allowing it to be marketed. It refers to general controls and regulatory requirements for medical devices, but not specific performance criteria or studies in the context you've outlined.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).