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The Cable Screw with Integral Crimp is indicated where a fracture may not be securely held by either a screw or a cerclage cable alone. The device can be used in conjunction with plating:

• humeral fractures
• medial malleolus fractures
• butterfly fractures requiring interfragmentary fixation with cerclage cabling
• femur fractures
• pelvic fractures
• forearm shaft fractures
• patellar fractures
• olecranon fractures
• proximal tibial and tibial shaft fractures

Pioneer Laboratories Cable Screw with Integral Crimp

I'm sorry, I cannot fulfill this request. The provided text is a 510(k) summary and approval letter for a bone fixation device, specifically a "Cable Screw with Integral Crimp." This document describes the administrative information, device identification, classification, and FDA approval of the device.

However, the provided text does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information to populate the table or answer the specific questions about device performance and study methodology. The document is solely focused on the regulatory approval process and not on the technical performance testing details.

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