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The Reusable Limb Holders, Disposable Limb Holders, and Quik Cuff Limb Holders are intended for patients who require limitations placed on their hand and leg movement.

Disposable Limb Holder (Synthetic Sheepskin-Double Tie): These limb holders have a 2 1/2-inch-wide by 12-inch-long synthetic cuff to which is sewn a 19-inch-long wrist strap. The wrist strap is 1 1/8-inch-wide polyester webbing. It is terminated with a 1 1/4-inch-wide metal buckle. Approximately 2 1/2 inches back from the buckle a 102inch-long strap (doubled to form two 51-inch-long sections) is sewn to the wrist band. Just beyond the point where this strap is attached, a one-inch-wide, seven-inch-long strip of Velcro loop material is sewn to the cuff. A 2 1/2-inch-long Velcro hook tab is stitched to the same end of the cuff as the buckle. The Velcro hook and loop position the cuff on the wrist or ankle, the wrist strap and buckle secure the device. Sold in pairs.

Disposable Limb Holders (Synthetic Sheepskin-Single Tie): Identical to the above except that they have a single 51-inch-long strap sewn to the wrist strap.

Disposable Limb Holders (Foam-Double Tie): Identical in construction to the Disposable Limb Holders (Synthetic Sheepskin-Double Tie) except that the cuff is made from 1/4-inch-thick polyurethane foam back with Velcro loop material.

Disposable Limb Holders (Foam-Single Tie): Identical to above except that they have a single 51-inch-long strap sewn to the wrist strap.

Reusable Synthetic Sheepskin Limb Holders: These limb holders have a 2 1/2-inchwide, 12-inch-long synthetic sheepskin cuff to which is sewn a 19-inch-long, 1 1/8inch-wide polyester wrist strap. The wrist strap is terminated with a metal buckle. A polyester strap of 1 1/8 inches in width is stitched to the wrist band approximately 2 1/2 inches beyond the buckle. This strap is 102-inches-long and is doubled to form two 51-inch-long sections.

Quik-Cuff Limb Holders: These have a 2 1/2-inch-wide, 12-inch-long synthetic sheepskin cuff to which is attached a 19-inch-long, one-inch-wide Velcro backstrap that includes a one-inch-wide Delrin d-ring through which the Velcro is secured. A single, 51-inch long strap is stitched to the cuff and the backstrap approximately at the center of the cuff.

This document is a 510(k) summary for limb holders, which are protective restraints. It describes the devices and their intended use. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in submissions for AI/ML-enabled medical devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove device performance. The provided text is a regulatory submission for a medical device that involves mechanical restraints, not an AI/ML-enabled device.

The information you are requesting (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in submissions for software as a medical device (SaMD) or AI/ML-enabled devices, which require extensive validation studies. This document predates the widespread use of such technologies in medical devices and focuses on the physical characteristics and regulatory status of the limb holders.

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