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Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The Frontier Devices Mandible Reconstructive System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Mesh System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Maxillofacial System: implantable bone screws and plates for oral and maxillofacial procedures including fractures, orthognathic, reconstructive procedures and revisions procedures when other treatments of devices have failed. Plates are made from medical grade unalloyed titanium (commercially pure Titanium grade 4, ASTM F-67). Screws are made from alloyed titanium (Titanium 6Al 4V, ASTM F-136).

Frontier Devices Orthognathic System: titanium bone plates and screws of various shapes and sizes. Plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-tapping screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

Frontier Devices Mandible Reconstruction System: titanium bone plates and screws of various shapes and sizes intended for use for maxillofacial, orbital reconstruction and specialized orthognathic surgery. Plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-tapping screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

Frontier Devices Mesh System: titanium meshes and screws of various shapes and sizes. Meshes are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-drilling screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

The provided text focuses on the 510(k) premarket notification for several Frontier Devices systems, emphasizing their substantial equivalence to predicate devices. It describes the devices, their intended use, and technology characteristics, concluding that performance tests on representative screws showed similar results to predicate screws.

However, the document does not contain the detailed information requested regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's an analysis based on the information available in the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document mentions "Performance tests on representative screws," but does not specify the number of screws tested nor the origin/nature of the test data (e.g., patient data, in-vitro testing). Given the device type (bone plates and screws), it is highly likely these were bench tests (mechanical, material, etc.) rather than clinical data.

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

• Not applicable/Not provided. For devices like bone plates and screws which are assessed through engineering/material performance tests, "ground truth" established by clinical experts (like radiologists) would not be the primary evaluation method for the performance tests mentioned. If any expert review was part of the design or substantial equivalence argument, it is not detailed.

4. Adjudication method for the test set

• Not applicable/Not provided. Since the nature of the "performance tests" is not detailed, and no ground truth establishment via consensus is mentioned, an adjudication method for test set ground truth is not 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 document describes medical devices (bone plates and screws), not an AI-based diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant or performed.

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

• Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

• Implicitly: Engineering standards and predicate device performance. The primary "ground truth" for these types of mechanical/material-based devices is adherence to recognized standards (like ASTM F-67, F-136) for material properties and demonstrating comparable or equivalent performance to already marketed (predicate) devices through appropriate engineering tests. Explicit "expert consensus," "pathology," or "outcomes data" are not mentioned as being used to establish ground truth for the performance tests cited.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" as this is not a machine learning or AI device.

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

• Not applicable. As above, no training set or AI development is described.

In summary, the provided document is a 510(k) summary for conventional medical devices (bone plates and screws). The acceptance criteria are broadly defined by substantial equivalence to predicate devices in material, dimensions, intended use, and general performance. The "study" proving this largely relies on "performance tests on representative screws" and comparisons of technical characteristics and indications for use to predicate devices, without detailed quantitative data for specific acceptance criteria or an evaluation methodology that would involve clinical experts or AI/software validation methods.

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