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The Synthes Cranial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive surgery of the midface and cranium; and orthognathic surgery of the maxilla and chin.

The Synthes Cranial Plates are titanium plates in a variety of shapes and sizes for various cranio-facial procedures.

This looks like a 510(k) premarket notification for a medical device rather than a study report for an AI/ML medical device. Therefore, the requested information about acceptance criteria, study design elements, and performance metrics for an AI device is not available in these documents.

Here's why and what can be extracted:

Why the requested AI/ML specific information is not available:

• Device Type: The device described is "Synthes Cranial Plates," which are physical titanium plates used in craniofacial surgery. This is a traditional medical device, not an AI/ML software device.
• 510(k) Context: A 510(k) submission is primarily to demonstrate substantial equivalence to a legally marketed predicate device. For traditional devices like these plates, this typically involves material testing, mechanical strength, biocompatibility, and clinical experience with equivalent devices, rather than performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML diagnostic or prognostic tool.
• Date: The approval date is February 20, 2002. AI/ML medical devices were not a prevalent category in medical device regulation at that time.

What can be extracted from the provided documents:

The documents are a "Summary of Safety and Effectiveness Information" and the FDA's clearance letter for the Synthes Cranial Plates.

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

   • Not applicable in the AI/ML context. For these cranial plates, the "acceptance criteria" were likely related to material properties (titanium), mechanical strength, biocompatibility, and sterilization, demonstrating equivalence to already marketed devices. These specific criteria and their performance results are not detailed in the publicly available summary provided. The summary states: "Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices." This implies that the device met the necessary performance and safety standards by being substantially equivalent to existing devices.

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. There is no "test set" in the context of an AI/ML study for this physical device. Testing would involve engineering and biocompatibility studies, not data-driven performance.

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. No expert ground truth establishment for a "test set" in the AI/ML sense.

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

   • Not applicable.

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 device is a physical implant, not an AI assistance tool for human readers.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

Summary of available information (re-contextualized for a traditional device):

• Device Name: Synthes Cranial Plates
• Manufacturer: Synthes (USA)
• Classification: Class II, per §872.4760 (Plate, Fixation, Bone) and §882.5250 (Burr Hole Cover).
• Indications for Use: Selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive surgery; orthognathic surgery of the maxilla and chin.
• Material: Titanium
• Basis for Clearance: Substantial equivalence to other legally marketed devices. The detailed evidence for this (e.g., specific tensile strength tests, fatigue tests, biocompatibility reports) would be in the full 510(k) submission, not typically in the public summary. The summary simply states "Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices," indicating that all necessary performance criteria for equivalence were met.

To reiterate, this document describes a conventional medical device (cranial plates) cleared in 2002, not an AI/ML medical device. Therefore, the questions specifically tailored to AI/ML device performance studies cannot be answered from this input.

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