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The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

The DeRoyal Industries, Inc. Tuxedo Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Designition Undering: The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic.

This 510(k) premarket notification describes a medical device, the DeRoyal Industries, Inc. Tuxedo Vest Restraint. However, it does not contain the information required to answer your request regarding acceptance criteria and a study proving device performance.

Here's why:

• Type of Device: This is a physical restraint device, not a diagnostic or AI-based device. The criteria you've asked for (such as sensitivity, specificity, sample sizes for test/training sets, ground truth establishment, expert review, MRMC studies, standalone performance) are typically applied to diagnostic algorithms or AI systems that analyze data (e.g., medical images, lab results) to provide an output.
• 510(k) Premarket Notification vs. Clinical Study Report: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on design, materials, intended use, and technological comparison with existing devices. It does not routinely include detailed clinical study performance metrics or AI algorithm validation data like what you are requesting.
• "Study" in this context: The "study" mentioned informally in the prompt's request refers to a clinical study or a technical validation study for performance metrics of an algorithm. For a physical restraint, proof of safety and effectiveness relies on demonstrating substantial equivalence to a predicate device, which usually involves a comparison of design, materials, and intended use, potentially supported by internal testing (e.g., tensile strength of materials) or literature review, rather than a clinical trial measuring diagnostic accuracy.

Therefore, I cannot provide the requested information because it is not present in the provided 510(k) document for this type of device.

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