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The Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

The 2.0 Locking Plate System consists of five different types of plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and L-), and 1.5 mm and 2.0 mm Self-drilling Locking Screws. The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system.

I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for a medical device. The document is a 510(k) summary for a Synthes 2.0mm Locking Plate System, primarily focusing on its regulatory approval, classification, and intended use. It does not include a section describing clinical studies, performance metrics, or details about ground truth establishment.

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