(302 days)
The Cathay Consolidated Super Air 9000 is indicated for the prevention and treatment of pressure ulcers ( bed sores).
Super Air 9000 Alternating Air Flotation Mattress System
The provided text is a 510(k) premarket notification approval letter for the "Super Air 9000 Alternating Air Flotation Mattress System." This document grants permission to market the device based on its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI-powered device or its performance metrics.
The letter focuses on regulatory approval, classification, and general controls applicable to the device. It states the indications for use (prevention and treatment of pressure ulcers) but does not provide performance data or study results.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document.
§ 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.