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The Synthes Mandibular Modular Fixation System is intended for use in oral, maxillofacial surgery, such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic surgery; and craniofacial surgery.

Synthes 2.0 mm Sagittal Split Plates have a curved design with six or eight static holes, are 1.25 mm thick, 24 mm - 29 mm in length, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm self-tapping screws.

The provided document is a 510(k) summary for the Synthes 2.0 mm Sagittal Split Plates. It is a premarket notification for a medical device and therefore describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria, device performance studies, or clinical trial data.

Specifically, the document focuses on regulatory approval based on equivalence rather than detailed performance evaluations against specific criteria. It confirms that the FDA reviewed the information and found the device substantially equivalent to a previously marketed device (Synthes Mandibular Modular Fixation System, K954385).

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from this document.

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