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For the prevention and treatment of pressure ulcers.

The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air cylinders as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.

This document is a 510(k) summary for a medical device (PressureGuard: Low Air Loss Mattress System) seeking clearance from the FDA in 1996. It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the provided text does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other specific details requested in your prompt (e.g., MRMC studies, standalone performance, training set details).

This document is a very high-level summary for regulatory submission, not a detailed scientific study report.

Therefore, I cannot fulfill your request with the given input. To provide the information you're looking for, I would need a different type of document, such as a clinical study report, a performance validation report, or a more detailed scientific publication associated with the device.

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