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The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.

The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial/craniofacial skeleton. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners.

This document is a 510(k) Summary of Safety and Effectiveness for the OsteoSymbionics Patient-Specific Cranial Implant. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided text.

Based on the provided text, here's what can be extracted and what is not available:

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

This information is not available in the provided text. The document is a 510(k) summary demonstrating substantial equivalence for a physical implant, not a study evaluating specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available. Since this is a 510(k) for a physical implant, there's no mention of a "test set" in the context of evaluating algorithm performance or diagnostic accuracy using patient data. The device is manufactured based on individual patient CT imaging data.

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)

This information is not available. There is no "test set" in the context of diagnostic performance that would require ground truth established by experts. The "ground truth" for the implant design is the patient's individual CT imaging data of their cranial defect.

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

This information is not available. There is no "test set" and thus 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

This information is not applicable and not available. This document is for a physical patient-specific cranial implant, not an AI/software device intended to assist human readers or provide diagnostic interpretations.

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

This information is not applicable and not available. The device described is a physical implant, not an algorithm.

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

For the design and manufacturing of the implant, the "ground truth" for the patient's anatomy and defect is the patient's CT imaging data.

8. The sample size for the training set

This information is not applicable and not available. The device is a physical implant custom-made for each patient; there is no "training set" in the context of an algorithm.

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

This information is not applicable and not available.

In summary, the provided text is a regulatory submission for a physical medical device (patient-specific cranial implant) under a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the kind of performance study details typically associated with the evaluation of AI/software medical devices, as it is not an AI/software device.

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