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Synthes 2.0 mm Craniofacial Locking Plates are indicated for selective trauma of the midface and craniofacial skeleton; craniofacial surgery, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Synthes 2.0 mm Craniofacial Locking Plates provide a locking screw/plate interface. The plates contain threaded holes which allow the use of 2.0 mm Locking screws, 2.0 mm Cortex screws and 2.4 mm Emergency screws.

The provided text is a 510(k) summary for a medical device called "2.0 mm Craniofacial Locking Plates." It is not a study report demonstrating the device's performance against acceptance criteria. Instead, it's a submission to the FDA to demonstrate substantial equivalence to previously approved predicate devices, which is a regulatory pathway for clearance, not a performance study as typically understood in the context of AI/ML device evaluations.

Therefore, most of the requested information cannot be extracted directly from this document. The document describes the device, its intended use, and its predicate devices, and asserts substantial equivalence, but it does not detail specific acceptance criteria for performance, a study proving those criteria were met, or information regarding ground truth, expert involvement, or sample sizes for testing or training sets.

Here's an attempt to address the points based on what is available and what isn't:

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

Explanation: This document is a 510(k) summary for demonstrating substantial equivalence, not a performance study against specific acceptance criteria. While the device (2.0 mm Craniofacial Locking Plates) is intended for certain surgical uses, the document does not define quantitative performance metrics or acceptance thresholds for its mechanical or clinical performance nor does it report the results of any such tests against these criteria. Instead, it asserts substantial equivalence to predicate devices.

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

• Sample size for test set: Not applicable/Not specified.
• Data provenance: Not applicable/Not specified.

Explanation: This document is not a study report demonstrating performance on a test set. It describes a medical device and its intended use for FDA clearance based on substantial equivalence.

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

• Number of experts: Not applicable/Not specified.
• Qualifications of experts: Not applicable/Not specified.

Explanation: No 'ground truth' or expert consensus process for a test set is described in this regulatory submission.

4. Adjudication method for the test set

• Adjudication method: Not applicable/Not specified.

Explanation: Since no test set or expert evaluation is detailed, no adjudication method is mentioned.

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

• MRMC study: No.
• Effect size: Not applicable.

Explanation: This device is a passive surgical implant (locking plates), not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

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

• Standalone performance study: No.

Explanation: This device is not an algorithm, so a standalone performance study as typically defined for algorithms is not applicable.

7. The type of ground truth used

• Type of ground truth: Not applicable/Not specified.

Explanation: No 'ground truth' is described as this is not a study assessing diagnostic or predictive performance.

8. The sample size for the training set

• Sample size for training set: Not applicable/Not specified.

Explanation: As this is a traditional surgical device, it does not involve machine learning and therefore does not have a 'training set'.

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

• Method for establishing ground truth: Not applicable/Not specified.

Explanation: As this is a traditional surgical device, it does not involve machine learning and therefore does not have a 'training set' requiring ground truth establishment.

In summary, the provided text is a regulatory filing for a medical device, establishing substantial equivalence to predicate devices, rather than a study demonstrating performance against specific acceptance criteria for an AI/ML medical device. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth is not present in this document.

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