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Portable powered low air loss flotation therapy mattress.
This document, K963674, is a 510(k) summary for the LUMEXAIR portable powered low air loss flotation therapy mattress. It is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
There is no information in this document regarding a clinical study to prove the device meets acceptance criteria.
The document primarily focuses on establishing "substantial equivalence" of the LUMEXAIR mattress to other legally marketed predicate devices, such as the Orthoderm HC System®, Akrotech 4000®, and Plexus 3000®. This means the submission argues that the new device is as safe and effective as these existing devices, often by demonstrating similar design, materials, and intended use.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because these details are not present in the provided 510(k) summary. The 510(k) process for devices like this typically relies on performance data and comparisons to predicate devices, rather than robust clinical trials with specific acceptance criteria as you might see for novel, high-risk devices or pharmaceuticals.
§ 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.