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The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

The subject of this 510(k) is the Synthes MatrixMANDIBLE Preformed Reconstruction Plates. These plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

This is a 510(k) summary for a medical device (Synthes MatrixMANDIBLE Preformed Reconstruction Plates), not a study evaluating software or AI performance. Therefore, most of the requested information regarding acceptance criteria for device performance, study design, expert involvement, and ground truth is not applicable.

This document describes the device, its intended use, and states that information supports substantial equivalence to a predicate device. Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device. In this context, "acceptance criteria" mainly refer to meeting the requirements for demonstrating substantial equivalence, which is assessed through a comparison of technological characteristics and safety/effectiveness information.

Here's a breakdown based on the provided text, noting where information is not available or relevant to a typical AI performance study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable: This document does not describe a clinical performance study with a test set of data points or images. It's a regulatory filing based on a comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: No clinical test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set

• Not Applicable: No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is not an AI/software device. No standalone algorithm performance was assessed.

7. The type of ground truth used

• Implied Ground Truth for Substantial Equivalence: The "ground truth" here is the established safety and effectiveness of the predicate device (Synthes MatrixMANDIBLE Plate and Screw System). The new device is deemed substantially equivalent if it can demonstrate it performs as safely and effectively as this predicate. This is a regulatory "ground truth" rather than a clinical outcome or expert consensus.

8. The sample size for the training set

• Not Applicable: This is not an AI/software device, so there is no training set in the AI sense.

9. How the ground truth for the training set was established

• Not Applicable: See point 8.

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