(66 days)
The Mighty*Air is used to help prevent and treat pressure ulcers.
Not Found
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.
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.