(245 days)
The intended use is to provide mobility to persons limited to a seated position
Not Found
This document is a 510(k) clearance letter from the FDA for a powered wheelchair, the Hoveround Teknique XHD MK-V. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the clearance is based on substantial equivalence to a predicate device, not on a new study demonstrating performance against specific acceptance criteria. The FDA determined that the new device is as safe and effective as a previously cleared device. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, etc.) is not present in this document.
§ 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).