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The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher.

The DeRoyal Industries, Inc. Pediatic Limb Holder is a protective restraint device that is intended for medical purposes to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials UsedPhysical Properties: The DeRoyal Pediatric Limb Holder is designed similar to those marketed by other manufacturers. The Pediatic Limb Holder is primarily comprised of polyester straps with hook and loop fasteners.

I am sorry, but the provided text does not contain the information requested to describe acceptance criteria and associated studies for a medical device. The document is a 510(k) summary for the DeRoyal Industries, Inc. Pediatric Limb Holder, which is a submission to the FDA for market clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed study results with acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes for test sets, data provenance, or ground truth establishment.
• Information regarding expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance or training set details.

The summary primarily describes the device, its intended use, and a technological comparison to predicate devices, asserting that it is "substantially equivalent" based on materials, size, attachment vehicles, length of use, and level of patient activity. It does not provide any quantitative performance metrics against pre-defined acceptance thresholds.

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These products are intended to limit limb movement or finger movement in a hospital bed or crib.

The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin.

This document describes an application for a 510(k) premarket notification for "Protective Restraints" (Pediatric limb holders) by J.T. Posey Co. It is a safety and effectiveness summary. The core of the submission emphasizes that the devices are identical to existing, legally marketed products by the same company, which were previously exempt from 510(k) procedures.

Given the nature of the document, which pertains to a premarket notification for a device that is identical to already marketed devices, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as typically understood for new or significantly modified medical devices that rely on performance metrics.

Here's why and what information is present:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The devices used for comparative purposes are identical to the pediatric limb holders as described in this submission and produced or sold by the J.T. Posey Co." This means the submission is based on substantial equivalence to existing devices, not on a new performance study demonstrating specific acceptance criteria. The purpose of this 510(k) is a response to a regulatory change ("Revocation of Exemptions from 510(k) Premarket Notification Procedures") rather than a technological advance requiring new clinical evidence.
• "Predicate device" rationale: The document highlights that FDA indicated manufacturers could reference their current products as legally marketed devices for comparison. This is the entire basis of the submission.
• Device history: The limb holders have been manufactured and in commercial distribution for up to 20 years.

Therefore, I cannot fill in the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not about demonstrating new performance but rather establishing legal equivalence to existing, long-marketed products under new regulatory requirements.

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