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The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surqical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variety of plate configurations for different anatomical applications. Unalloyed commercial pure Grade 1, 2 and 4 titanium, titanium alloy plates as well as titanium alloy screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial tissues.

The provided document does not contain information about acceptance criteria or a study proving the device meets them. It's a 510(k) premarket notification for a medical device (bone fixation plates for craniomaxillofacial surgery), and the FDA letter indicates that the device has been found substantially equivalent to predicate devices.

Therefore, I cannot provide the requested table and study details.

Here's why the information isn't present in this document:

• 510(k) Substantial Equivalence: This regulatory pathway (510(k)) primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use, not necessarily providing new performance studies against specific acceptance criteria.
• Lack of Clinical Study Details: The document focuses on regulatory classification, intended use, and comparison to predicate devices, not on detailed clinical trial results or performance against quantitative acceptance criteria for a novel technology like an AI device would require.
• Device Type: The device described is a physical medical implant (bone fixation plates), not an AI/software as a medical device (SaMD). Performance for such physical devices is often evaluated through bench testing, material properties, and sometimes animal studies, rather than the types of clinical or reader studies described in your prompt for AI.

If you are looking for information regarding acceptance criteria and performance studies for an AI/SaMD, you would typically find that in a much more detailed clinical study report or a different section of a regulatory submission.

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The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. The bone plates will be manufactured of commercially pure titanium.

This is a 510(k) premarket notification for a medical device (Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, explicit "acceptance criteria" for device performance in the context of an AI study, and a "study that proves the device meets the acceptance criteria" as typically described for AI/algorithm performance, are not present in the provided text.

The document primarily relies on comparison with predicate devices to establish substantial equivalence regarding technological characteristics and intended use.

However, I can extract information related to the device and its intended purpose, which could hypothetically form the basis of acceptance criteria if this were an AI device.

Here's a breakdown of the requested information based on the provided document, noting that many items are not applicable (N/A) because this is not an AI device or an AI study:

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)

• N/A. This is a 510(k) submission for a physical medical device, not an AI device or an AI study. There is no "test set" in the context of an algorithm's performance. The submission relies on a comparison of technical characteristics to predicate devices.

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)

• N/A. Since this is not an AI device or an AI study, there is no ground truth, test set, or experts establishing ground truth in this context. The FDA's review process itself involves experts within the agency, but this is for regulatory clearance based on substantial equivalence, not for evaluating an algorithm's performance against a ground truth.

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

• N/A. As there is no test set for an algorithm, there is no adjudication method 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

• N/A. No MRMC study was done, as this is not an AI device.

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

• N/A. This is a physical medical device, not an algorithm.

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

• N/A. There is no ground truth described as this is not an AI study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices and the physical properties of the materials and design.

8. The sample size for the training set

• N/A. This is a physical medical device, not an AI algorithm, so there is no training set.

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

• N/A. As there is no training set, there is no ground truth for it.

In summary, the provided document is a 510(k) summary for a physical medical device (bone plates and screws). The regulatory pathway for such devices primarily involves demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific statistical acceptance criteria as would be the case for a novel AI/software as a medical device (SaMD).

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