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The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress with low air loss. The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.

The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air sacks 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 submitted to the FDA in 1996. It describes a "Powered Low Air Loss Mattress System" intended for the prevention and treatment of pressure ulcers.

Critically, this document describes a physical medical device, not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, the requested information regarding AI model performance, training sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this submission.

The 510(k) process for devices like this primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves comparing technological characteristics, intended use, and performance claims to the predicate. Clinical studies, when present for these types of devices, typically focus on safety and effectiveness in a broader sense (e.g., patient outcomes related to pressure ulcer prevention/treatment), rather than the specific AI-related metrics you've requested.

Therefore, I cannot fulfill your request as written because the provided input does not describe an AI/SaMD product.

If you can provide a 510(k) summary, clinical study report, or other documentation for an AI-powered medical device, I would be happy to attempt to extract the requested information.

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