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

The DeRoyal Industries, Inc. Pediatric Vest Restraint device that is intended for medical purposes to limit pediatric patient movements thereby enabling examination or protection of the patient or others. The Pediatic Vest Restraint is also available as an immobilization shirt which prevents the pediatric patient's arms from bending at the elbows with the use wooden staves (tongue depressors).

Device Design/Materials Used/Physical Properties: The DeRoyal Pediatric Vest Restraint is designed similar to those marketed by other manufacturers. The Pediatic Vest Restraint is primarily comprised of flannel or cool knit with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.

The provided text describes a medical device, the DeRoyal Industries, Inc. Pediatric Vest Restraint, and its similarity to predicate devices. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

This 510(k) summary focuses on demonstrating substantial equivalence to previously marketed devices based on design, materials, size, intended use, and other characteristics. It does not include data from a clinical or performance study that would typically be required to prove a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy.

Therefore, I cannot populate the table or answer the specific questions about studying a device's performance against acceptance criteria using the provided text. The document is essentially a comparative analysis of device features, not a performance study report.

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