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The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others.

The DeRoyal Industries, Inc. Strait Jacket is a protective restraint device that is intended for medical purposes to restrict patient upper body movements thereby enabling protection of the patient or others.
Design Design/Materials Used/Physical Procerties: The DeRoyal Strait Jacket is designed similar to those marketed by other manufacturers. The Strait Jacket is primarily comprised of white armyduck cotton and steel nickel plated fasteners.

The provided document is a 510(k) summary for a medical device called "DeRoyal Industries, Inc. Strait Jacket." It is a protective restraint device submitted in 1996.

This document does not contain any information regarding acceptance criteria, device performance metrics, or study details that are typically associated with evaluating AI/ML-driven medical devices. The document describes the device, its intended use, and a technological comparison with predicate devices, focusing on materials, size, and use characteristics.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size," "ground truth," "expert adjudication," "MRMC studies," or "standalone performance" do not apply to this type of device submission from 1996, which predates the widespread use of AI/ML in medical devices and the associated regulatory scrutiny for their performance.

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