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The Synthes Low Profile Neuro Contourable Mesh Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The Synthes Low Profile Neuro Contourable Mesh Plates are manufactured from Titanium and consists of a variety of shapes and sizes designed for various cranio-facial procedures. These plates are now available to the user sterile.

The provided text is a 510(k) summary for the Synthes (USA) Low Profile Neuro Contourable Mesh Plates. It is primarily a regulatory document for a medical device and therefore does not contain the detailed study information typically found in a clinical trial report or a performance study for an AI/ML medical device.

This document is for a physical medical device (bone plates) that falls under Class II regulation and is cleared based on substantial equivalence to a previously marketed predicate device, not on specific performance criteria derived from a study like those for AI/ML devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device. The categories you've asked for (sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth, training set size, etc.) are all relevant to the validation of AI/ML algorithms, which is not what this document describes.

The key takeaway from this document regarding the "study" is:

• Substantial Equivalence: The device's clearance is based on demonstrating substantial equivalence to a legally marketed predicate device (Synthes Low Profile Neuro System). This means it has the same intended use, technological characteristics, and safety and effectiveness as the predicate.
• "Study" Type: The "study" mentioned is likely the documentation and comparisons provided to the FDA to demonstrate substantial equivalence, focusing on material, design, manufacturing, and intended use, rather than a clinical performance study with specific metrics.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML device validation.

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