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OSTEON, OSTEON Sinus, OSTEON Lifting are intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

• Periodontal/Infrabony defects
• Ridge augmentation
• Extraction sites (implant preparation/placement)
• Sinus lifts
• Cystic cavities

This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.3~2.0 mm. It is supplied sterile by gamma irradiation.

The provided text is a 510(k) summary for a medical device (OSTEON, OSTEON Sinus, OSTEON Lifting - bone grafting material). It describes the device, its intended use, and states that it has been subjected to safety, performance, and product validations, ensuring compliance with regulations. The document then concludes that the device is substantially equivalent to a predicate device.

However, the 510(k) summary does not contain specific acceptance criteria, details of a study proving those criteria were met, or any information related to AI/algorithm performance or ground truth establishment.

Therefore, I cannot provide the requested information from the given text.

Based on the provided document, the following information is not available:

1. A table of acceptance criteria and the reported device performance: The document only states that "OSTEON, OSTEON Sinus, OSTEON Lifting have been subjected to extensive safety, performance and product validations prior to release." It doesn't list specific acceptance criteria or performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. This type of device (bone grafting material) would typically not involve expert consensus for ground truth in the way AI algorithms for diagnostic imaging would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This document is for a bone grafting material, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is not relevant and not discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a bone graft, "ground truth" would likely relate to biocompatibility, osteoconductivity, and mechanical properties, not diagnostic accuracy.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided text describes a traditional medical device (bone grafting material) 510(k) submission, which does not involve AI or the types of performance studies and ground truth methodologies typically associated with AI/ML-driven diagnostic devices.

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