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The Orthofix MIOT Plating System is intended for non-load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures and reconstruction.

The Orthofix MIOT plating system consists of bone plates made of stainless steel The Oftholix MIOT plaining cyclom small bone fragments. They are anatomically designed for the internamized fragment adapted approach. If necessary, they precontoured and allow a casternization in the sare available in different shapes Can be bent to doquire the doch on a left and a right configuration and come in (Straight, C =, 1 - and oblique - onaps), in a levening stainless steel FFS wires. Plates umerent sizes. They are attached to FFS wires, depending upon its shape and size. can accommodule throughts for the insertion and removal of the plates.

The provided 510(k) summary for the Orthofix MIOT Plating System (K051945) does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.

This document is a "Substantial Equivalence" determination, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, and intended use, rather than conducting a new performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence, not on a performance study with defined acceptance criteria.

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