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The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable. It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.

The Acumed Wire Crimp Sleeve is a block with two holes to be used with commonly used cerclage wire. The cerclage wire is passed around the bone, passed through the crimp block, and crimped in a manner identical to the Osteo-Clage Cable System and similar to the Howmedica Dall-Miles Cable System. The only difference being the use of wire instead of cable.

This document is a 510(k) summary for a medical device (Acumed Wire Crimp Sleeve) and does not contain the information requested about acceptance criteria and a study proving device performance.

The provided text focuses on:

• Device Description: What the Acumed Wire Crimp Sleeve is and how it's used.
• Intended Use: General orthopedic repairs where cerclage wire is indicated.
• Material: Titanium.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to previously cleared devices (Acumed Cerclage Wire Crimp, Osteo-Clage Cable System, Howmedica Dall-Miles Cable System). This claim is based on similarity in design, materials (with specified differences), and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert details, as this type of information is not present in the provided 510(k) summary.

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