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Facial restoration and augmentation.

PermaMesh is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

This document is a 510(k) summary for a medical device called "PermaMesh Hydroxylapatite Matrix," submitted in 1996. It describes the device, its intended use, and compares it to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document focuses on the physical characteristics and composition of the device, its classification, and comparison to existing products. It does not mention any performance metrics, clinical trials, or validation studies in the context of effectiveness or safety in a patient population.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and study design based on the input text. The information required for those points (performance data, sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance, training set details) is entirely absent from this 510(k) summary excerpt.

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