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The DeRoyal Industries, Inc. Sleeveless 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 patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

The DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoval Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeved/ Sleeved/ Sleeved/ of cool knit, cotton, or with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.

This document does not describe acceptance criteria for a medical device and a study to prove the device meets said criteria.

Instead, this is a 510(k) premarket notification summary for a Sleeved/Sleeveless Vest Restraint. The purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to establish novel performance criteria through a new study.

Therefore, I cannot provide the requested information based on the text provided. The document focuses on:

• Device identification and categorization.
• Description of the device's design, materials, and intended use.
• Comparison of the device's technological characteristics with predicate devices to show it is "substantially equivalent." This comparison, as shown in the table, highlights that characteristics like materials, size, vehicles for attachment, length of use, and level of patient activity are "Same" as the predicate devices.

There is no mention of:

1. Acceptance criteria or reported device performance.
2. Sample sizes, data provenance, or test sets.
3. Experts establishing ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Types of ground truth.
8. Sample size for the training set (as this is not an AI/ML device).
9. How ground truth for a training set was established.

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