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The DeRoval Industries. Inc. Pediatric Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others. The Pediatric Mittens can be attached to a bed or used alone.

The DeRoyal Industries, Inc. Pediatric Mittens are a protective restraint device that are intended for medical purposes to limit pediatric patient finger and hand movements thereby enabling examination or protection of the patient or others. Limb restraint straps that attach to the Pediatric Mittens are optional, if needed.

Device Design/Materials Used/Physical Properties: The DeRoyal Pediatic Mittens are designed similar to those marketed by other manufacturers. The Pediatric Mittens are primarily comprised of 100% polyester and cotton with hook and loop fasteners.

This document is a 510(k) summary for a medical device called "DeRoyal Industries, Inc. Pediatric Mittens." It describes the device, its intended use, and compares it to predicate devices. It does not contain information about acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters you've requested (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.).

The document focuses on demonstrating substantial equivalence to existing legally marketed devices based on shared characteristics like materials, size, attachment options, length of use, and patient activity level. It does not present performance data or clinical study results in the way required by your prompt.

Therefore, I cannot provide the requested table and study details.

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