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OSTEON is 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

OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of beta-Tricalcium Phosphate (B -TCP). Hydroxyapatite(HA) and OSTEON presents ત્વ interconnected porosity structure, similar to that of human cancellous bone. OSTEON is available as irregular shaped powders of size 0.3~2.0 mm. It is supplied sterile.

This 510(k) summary does not contain information typically found in a study demonstrating device performance against specific acceptance criteria. This document is a premarket notification for a bone grafting material (OSTEON) and focuses on establishing substantial equivalence to a predicate device (MBCP™).

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because these elements are not present.

The document primarily states:

• Device Description: OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of beta-Tricalcium Phosphate (β-TCP) and Hydroxyapatite (HA).
• Intended Use: As a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects (e.g., periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, cystic cavities).
• Comparison to Predicate Device: OSTEON has similar technological characteristics (main material, indication for use, and design) to MBCPTM.
• Safety and Performance: "OSTEON has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (However, the specific results or criteria are not detailed).
• Conclusion: "Based on the information provided in this premarket notification GENOSS Co., Ltd. concludes that OSTEON is safe and effective and substantially equivalent to predicate devices as described herein."

For medical device clearances based on substantial equivalence, the primary "acceptance criteria" is typically demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantitative performance metrics against a defined gold standard in a clinical study presented within the 510(k) summary itself. The burden of proof primarily lies in showing similar technological characteristics and indications for use, supported by general safety (e.g., biocompatibility) and performance data, not necessarily complex multi-reader studies or detailed performance metrics.

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