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The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

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The provided text is a 510(k) summary for a medical device (Titanium Hip Tool™ Locking Plate), indicating its administrative information, intended use, and substantial equivalence to a predicate device. It is a regulatory document and does not contain details about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in a scientific study or clinical report.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for test sets
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study details (effect size)
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document is focused on demonstrating regulatory compliance based on substantial equivalence rather than presenting detailed performance study data.

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