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Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

The Lorenz Titanium Fracture / Rexastructive Devices are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for neassion of modition of marco on a varior of manum natures. The screws have both cross drive and canter dive head features, lag sames and as males will includes will includes straight, angle, double angle, and crescent, options with various lengths and thickness.

The Lorenz Titanium Fracture / Reconstructive Pre-Bent Plates are comprised of a specific range of existing plates. The plate is pre-shaped based on a CT Scan provided by the Surgeon specifically for a certain patient.

The Pro-batt plates may, in special cases, be attached to our Temporary Add-on Condyle (cleared under K002790). In these cases, the package inserts for both the Temporary Add-on Condyle will be included with the product. The poduct of the postkage insert for the Temporay Add-on Condyle is specific in identifying that on only indicated for temporary reconstruction and is not intended to a permanent implant

This document is a 510(k) summary for the Walter Lorenz Surgical Mandibular Fracture/Reconstruction Devices and Pre-bent Plates. It does not describe a study that uses acceptance criteria and reports on device performance in the way requested by the prompt for an AI/CADe device. Instead, it details the substantial equivalence of the new device to previously cleared predicate devices.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) because this document does not pertain to the validation of an AI/CADe system. It is a regulatory submission for a physical surgical device.

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