(265 days)
The power wheelchair is used as a mobility device for individuals who have limited The power which is assult is assult in the wheelchair is designed especially for larger individuals and can be used for outside mobility or in clinical applications.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair, the Overlander PEV 2000. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics.
The letter focuses on the substantial equivalence determination for regulatory purposes, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and good manufacturing practices.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the 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).