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Endobon® Xenograft Granules are used in the following dental and/or surgical procedures:

• Alveolar ridge augmentation/reconstruction. .
• . Filling of defects after root resection, apicoectomy, and cystectomy.
• . Filling alveoli after tooth extraction.
• . Sinus elevation.

This product should not be used in non-peridontal mandibular applications.

Endobon Xenograft Granules consist of bovine derived hydroxyapatite ceramic granules. Endobon - hydroxyapatite xenograft granules are derived from cancellous bovine bone that are used as an implantable material to function as a non-resorbable osteoconductive scaffold for dental applications. A two-step, high-temperature manufacturing process (pyrolysis at a temperature above 900 ℃ and sintering at a temperature above 1200ºC) allows complete deproteinization as well as destruction of potential residual bacteria, virus and prions. The slow resorption rate attributed to Endobon and other similar materials processed in the same manner relates to the crystalline-like structure of 95% of the hydroxyapatite (HA) in Endobon. The resorption rate of hydroxyapatite (HA) increases as crystallinity decreases, and the crystallinity is highly dependent on the sintering temperature. High sintering increase in crystallinity. The precise chemical name of the hydroxyapatite is pentacalcium hydroxide (tris) phosphate [Ca5 (PO4)3 OH].

The provided document is a 510(k) Pre-Market Notification for a medical device called "Endobon Xenograft Granules". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as might be seen for novel devices or PMAs.

Therefore, the document does not contain all the information requested about acceptance criteria and a study proving device performance in the typical sense of a clinical trial. Instead, it focuses on demonstrating equivalence through comparison to an existing device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for a 510(k) submission focused on substantial equivalence. The "acceptance criteria" here relate to demonstrating that the new device (Endobon Xenograft Granules) is as safe and effective as the predicate device (BioOss).

The document states:

• "Endobon Xenograft Granules has the same intended use and, physiochemical properties as BioOss."
• "Any differences in material, chemical composition, or physical structure, do not raise any new questions of safety or effectiveness."
• "Extensive equivalency assessments demonstrates that Endobon Xenograft Granules is as safe and effective as BioOss."

Therefore, the "acceptance criteria" implicitly are that the new device's properties and performance are comparable to the predicate device to the extent that no new questions of safety or effectiveness are raised. The "reported device performance" is that it meets this equivalency.

A table of chemical composition is provided comparing Endobon and Bio-Oss, which serves as part of the "reported device performance" for demonstrating physicochemical similarity:

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

The document explicitly states "Nonclinical Performance Data: N/A" and "Clinical Data: N/A". This indicates that no specific new test set or clinical study was conducted for this 510(k) submission. The assessment relies on comparison to the predicate device and potentially prior literature, as mentioned in the conclusion "literature review and equivalency assessment".

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. As no new test set or clinical data was generated, there was no need for experts to establish ground truth in the context of this submission. The chemical comparison data is from a published study (Jensen et al. 1996).

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

Not applicable. No new test set requiring adjudication was used.

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 software. No MRMC study was conducted.

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

Not applicable. This device is a bone grafting material, not an algorithm or AI.

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

The "ground truth" for this submission is based on the established safety and effectiveness of the predicate device (BioOss), which is legally marketed. The submission aims to demonstrate that Endobon Xenograft Granules are sufficiently similar to BioOss to infer the same safety and effectiveness. The chemical composition data from Jensen et al. 1996 provides empirical evidence for this similarity.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/machine learning device.

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

Not applicable. No training set was used.

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Endobon is used in the following dental and/or oral surgical procedures :

• alveolar ridge augmentation/reconstruction
• filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall
• filling of periodontal bone pockets in the jaw (granules I)
• filling bone defects after apicetomy
• filling alveoli after tooth extraction
  This product should not be used in non-periodontal mandibular applications.

Endobon is available in pre-formed shapes (i.e. blocks or cylinders) and granules sizes. This material is intended to fill voids or defects in bone and should not be used in nonperiodontal mandibular applications. Endobon is a porous hydroxyapatite ceramic made from bovine cancellous bone. Hydroxyapatite (pentacalcium hydroxide [tris] phosphate) is both the main constituent of this ceramic bone substitute and a major constituent of the inorganic phase of human and animal bone. Endobon is considered nonresorbable and is used to permanently fill or reconstruct bony defects.

The provided text is a 510(k) summary for the Endobon device, a porous hydroxyapatite ceramic used as a bone substitute. It describes the device, its intended uses, and asserts its biocompatibility and effectiveness based on preclinical and clinical studies. However, it does not contain the specific details required to complete your request for acceptance criteria and a detailed study description.

Here's a breakdown of why and what information is missing:

• Acceptance Criteria and Reported Performance Table: The document states "The efficacy of Endobon® is based on biomechanical testing and clinical documentation. Clinical, radiologic, and histologic findings from clinical trials demonstrate the biocompatibility of Endobon® and confirmed its suitability for the desired indications." This is a high-level statement but does not provide specific quantitative acceptance criteria (e.g., bone density increase by X%, fusion rate of Y%) or the numerical performance results against those criteria.
• Sample Size and Data Provenance for Test Set: The document mentions "over five years of clinical experience" and "clinical trials" but does not specify the sample size of these trials for a test set, nor the country of origin, or if they were retrospective or prospective.
• Number of Experts and Qualifications for Ground Truth: There is no mention of independent experts used to establish ground truth in any clinical study, their number, or their qualifications.
• Adjudication Method: The document does not describe any adjudication methods used for a test set.
• MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to human readers improving with or without AI assistance. This is likely because the device is a bone substitute, not an AI diagnostic tool.
• Standalone Performance Study: The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here as Endobon is a physical implant, not a software device or AI.
• Type of Ground Truth Used: While it mentions "clinical, radiologic, and histologic findings," it doesn't specify how these were integrated or prioritized to form a definitive "ground truth" for evaluating the device's efficacy. For example, was a specific histology finding paramount, or a composite score?
• Sample Size for Training Set: The document does not discuss a training set, as it pertains to AI/machine learning models, which is not applicable to this medical device.
• How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided 510(k) only offers a general affirmation of safety and effectiveness based on existing studies and clinical experience, but it lacks the granular detail about specific study designs, acceptance criteria, and performance metrics that your request asks for. This level of detail is typically found in the full clinical trial reports or FDA review memoranda, which are not part of the publicly available 510(k) summary.

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