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Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

• Intrabony periodontal osseous and furcation defects
• Augmentation of bony defects of the alveolar ridge ●
• Filling tooth extraction sites ●
• Sinus elevation grafting .

Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.
BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

This document is an FDA 510(k) summary for the Straumann® BoneCeramic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, many of the requested elements are not applicable in the context of this 510(k) summary.

However, based on the provided text, here’s an analysis:

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

The document does not present specific acceptance criteria in a quantitative table format with corresponding device performance metrics for a clinical study. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (K040646 Straumann Granules) by showing similar technological characteristics and relying on the predicate's established safety and effectiveness.

The "reported device performance" is primarily qualitative and inferred from the long-term use of the predicate device and the new device sharing similar characteristics.

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

This information is not provided. The document refers to "review of the relevant clinical literature included 18 clinical publications," but does not detail the sample sizes, study designs (retrospective/prospective), or data provenance of these publications. For the internal device performance checks (biocompatibility, packaging, sterilization, pyrogenicity), the "sample size" would refer to the number of units tested, but this detail is not given.

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. The document does not describe a test set with a ground truth established by experts in the context of an AI/image analysis device. The "ground truth" for the device's performance is inferred from compliance with standards and clinical literature demonstrating real-world efficacy.

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

Not applicable. There is no mention of an adjudication method as would be used in a study evaluating diagnostic accuracy with expert consensus.

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 bone grafting material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

For the "clinical performance," the ground truth is indirectly based on outcomes data from the "device marketing and complaint history" and the "relevant clinical literature" (which would detail clinical outcomes in patients). For the technical characteristics (biocompatibility, sterilization, pyrogenicity, packaging), the ground truth is established by adherence to international standards (e.g., ISO, ASTM) and in vitro or in vivo test results demonstrating compliance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable. As above, this is not an AI/machine learning device.

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