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The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.

The Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable to match the anatomy, have a limited contact design, and are tapered at the plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination dynamic compression / locking screws holes (combi-holes). The plates in this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for preliminary fixation with k-wires.

The provided document is a 510(k) premarket notification for a medical device (bone plate) and does not contain any information about an AI/ML device or its associated studies and acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for an AI/ML device.

The document describes a conventional bone fixation plate and its substantial equivalence to predicate devices, focusing on materials, design, and intended use as per medical device regulations. It is not an AI/ML submission.

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