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Mini and Micro Fragments Reconstruction System – NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System – NEOFACE is a fixation system for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. It consists of implant plates and implant screws. The plates of the subject system include mini and micro fragment reconstruction plates. Plates are made of commercially pure titanium and screws are made of titanium alloy.

The provided text describes a medical device, the "Mini and Micro Fragments Reconstruction System - NEOFACE," and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of an AI/algorithm-based system.

The document is a traditional 510(k) submission for a physical medical implant system (plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices through design principles, materials, technological characteristics, and mechanical testing.

Therefore, many of the requested bullet points, particularly those related to AI/algorithm performance (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance), cannot be extracted from this document as they are not applicable to the type of device described.

Here's what can be extracted based on the provided text, with explanations where information is missing or not applicable:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This document describes mechanical testing of physical implants, not a "test set" in the context of an AI/algorithm. Mechanical testing generally involves predefined samples of the manufactured devices. The provenance of the testing (e.g., where the tests were conducted) is not specified beyond "NEOORTHO PRODUTOS ORTOPÉDICOS S/A" being located in Brazil.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic algorithms. For mechanical testing, the "ground truth" is established by the standardized test methods (ASTM F382 and F543) and the physical properties of the materials and device design. The "experts" involved would be engineers or technicians performing the tests, but their specific number or qualifications are not detailed here, as it's typically understood to be standard practice for such testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessment. Mechanical testing relies on objective measurements according to standardized protocols, not adjudication.

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

• No. An MRMC study is not mentioned as this is a physical medical device, not an AI or imaging diagnostic tool.

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

• No. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device revolves around the physical and mechanical properties of the materials and the manufactured implants, as evaluated against established ASTM standards (F382 for plate bending, F543 for screw torsional strength, breaking angle, and axial pullout strength).

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/algorithm device.

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

• Not Applicable. There is no "training set" and therefore no ground truth to be established for it.

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