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Synthes Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.

Resorbable Cranial Clamps consist of two disks connected by a ratcheting shaft with an available optional spacer.

This document is a 510(k) summary for the Synthes Resorbable Cranial Clamps, submitted to the FDA in 2002. It primarily establishes substantial equivalence to predicate devices and describes the device's technical specifications and intended use.

Crucially, this document does not contain information about the acceptance criteria or a study that directly proves the device meets specific performance criteria using a quantitative approach commonly seen for AI/software-based medical devices. It's a regulatory clearance document for a physical medical device (resorbable cranial clamps), not an algorithm or diagnostic software.

Therefore, many of the requested categories related to algorithmic performance and clinical study design for such a device (like sample size for test sets, expert consensus, MRMC studies, standalone performance, training sets) are not applicable or not present in this type of document.

Here's an attempt to address the request based only on the provided text, recognizing its limitations for the specific questions posed:

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

This document does not present specific acceptance criteria or quantitative performance data in the way one would for an AI/software device (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating substantial equivalence to existing legally marketed predicate devices, which implies that the new device performs similarly in terms of safety and effectiveness for its intended use.

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

• Sample Size: Not specified in this document. Substantial equivalence for a physical device like this is typically supported by engineering testing, biocompatibility data, and comparison of design features, not specifically a "test set" in the context of diagnostic accuracy.
• Data Provenance: Not specified. This would typically involve bench testing results or potentially pre-clinical animal studies, but the document does not detail these.

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. The concept of "ground truth" established by experts for a test set is not directly relevant to this type of device clearance. Instead, safety and effectiveness are evaluated based on material science, mechanical testing, and clinical rationale.

4. Adjudication method for the test set:

• Adjudication method: Not applicable/not specified.

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, this is not an AI-assisted diagnostic device. This is a physical medical implant. Therefore, MRMC studies are not relevant here.

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

• Standalone Performance: Not applicable. This is not an algorithm.

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

• Type of Ground Truth: Not applicable in the context of diagnostic accuracy. For a physical device, the "ground truth" relates to its physical and biological performance characteristics (e.g., mechanical strength, biocompatibility, degradation profile, ability to achieve its intended mechanical function) as assessed through engineering studies and comparison to established predicate devices.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Ground Truth for Training Set: Not applicable.

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