FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Mighty Air", which is used to help prevent and treat pressure ulcers. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.

The letter only states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and that it can be marketed subject to general controls. It does not elaborate on the specific testing or data that supported this determination.

Therefore, I cannot provide the requested information based on the given text.

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K Number

K970743

Device Name

BCW POWER ADVANTAGE WHEELCHAIR

Manufacturer

WHEELCHAIRS OF KANSAS

Date Cleared

1997-04-30

(62 days)