(96 days)
The Electric wheelchair 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.
Electric Wheelchair (MODEL H)
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that an "Electric Wheelchair (MODEL H)" meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device, which indicates that the device is substantially equivalent to a legally marketed predicate device.
The letter outlines:
- The device name and classification.
- The FDA's determination of substantial equivalence.
- General controls and other regulations the device is subject to (e.g., Quality System regulation, UDI rule).
- Contact information for various FDA departments.
- The "Indications for Use" statement for the Electric Wheelchair (MODEL H).
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or study design for testing.
- Information on expert involvement, ground truth establishment, or adjudication methods for any test set.
- Any mention of an MRMC comparative effectiveness study or standalone algorithm performance.
- Details about training sets or how ground truth for training data was established.
Therefore, I cannot fulfill your request for this specific information based on the provided text.
§ 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).