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The Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the Distal Humerus.

The Synthes 3.5 mm Broad LCP & 4.5 mm Broad LCP Distal Humerus Plates are contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate has dynamic compression holes combined with locking holes which accept 3.5 & 4.5 mm cortex, 3.5 & 4.5 mm self-tapping cortex, 3.5 mm shaft, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm cancellous screws. The plates are available in various lenghts.

The provided document is a 510(k) summary for a medical device (Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plate) seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software device through a standalone study.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not applicable (N/A) to this specific document.

The document primarily relies on the concept of substantial equivalence to a predicate device (Synthes 3.5 mm LCP Reconstruction Plate) rather than a performance study with defined acceptance criteria and statistical analysis.

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