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ODONCER Bone Grafting Material is recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge.
• Filling of infrabony periodontal defects.
• Filling of defects after root resection, apicoectorny, and cystectomy.
• Filling of extraction sockets to enhance preservation of the alveolar ridge.
• Elevation of the maxillary sinus floor.
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration and Guided Bone Regeneration.
• Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration.

ODONCER is an osseo-conductive powder implant made of synthetic beta tricalcium phosphate (β-ΤCP (Cα3(PO4)2) indicated for bone grafting in dental applications.

This submission for ODONCER Bone Grafting Material (K062102) is a 510(k) premarket notification. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, based on the provided document, the following sections cannot be fully populated as they pertain to performance testing and studies which are not characteristic of this type of submission.

Here's the information that can be extracted and a clear indication of why other information is not present:

No Acceptance Criteria or Device Performance Table

The provided 510(k) summary (K062102) establishes substantial equivalence for the ODONCER Bone Grafting Material. This type of submission does not typically involve defining specific acceptance criteria for performance or reporting device performance in the manner of a clinical study. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The summary states: "ODONCER does not incorporate any new technological characteristics as compared to the predicate devices. ODONCER and the predicate devices are made from the same material (pure-phase P-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade B-TCP to be used in surgical implant applications. ODONCER is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility."

This indicates that the "acceptance criteria" are effectively the characteristics and safety/performance profile of the predicate devices and adherence to relevant material standards (ASTM F1088-04).

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

As explained above, this submission focuses on substantial equivalence rather than reporting specific performance metrics against defined acceptance criteria from a clinical study. The "performance" is considered equivalent to the predicate devices due to shared material and characteristics.

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

Not applicable. No separate "test set" for performance evaluation in a clinical study is described within this 510(k) summary. The submission relies on non-clinical data and comparison to predicate devices, not human or large-scale animal testing that would involve a "test set" in the context of device performance metrics.

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. No "ground truth" was established for a test set regarding device performance in the context of this 510(k) summary. The ground truth for safety and effectiveness is assumed to be established by the predicate devices.

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

Not applicable. No adjudication method for a test set is 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

Not applicable. This is a bone graft material, not an imaging device or an AI-assisted device. Therefore, MRMC studies and AI-related metrics are irrelevant.

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

Not applicable. This is a bone graft material, not an algorithm-based device.

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

For a 510(k) submission like this, the "ground truth" for demonstrating safety and effectiveness relies on:

• Established performance and safety of legally marketed predicate devices.
• Adherence to recognized standards: Specifically, ASTM F1088-04 for medical grade B-TCP.
• Nonclinical tests: The summary mentions "Summary Nonclinical Tests" addressing structure, porosity, form, packaging, sterility, and biocompatibility, implying these were evaluated to ensure similarity to predicates and compliance with standards.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a bone graft material.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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