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OSTEON II 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

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 0.2~2.0 mm. It is supplied sterile by gamma irradiation.

The provided document describes the OSTEON II device, a synthetic bone grafting material. It outlines the device's characteristics, indications for use, and performance data for biocompatibility and bench testing. However, it does not include specific acceptance criteria or a study designed to demonstrate that the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (OSTEON) based on similar materials, indications for use, and design.

Here's an breakdown of the information that is available and what is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: The document does not provide numerical acceptance criteria for any of these tests (e.g., "Cytotoxicity score must be < X"). It states that the tests were "completed" and "results show that the materials... are non-toxic and non-sensitizing" and "All test results demonstrate that the materials... met the established specifications." It doesn't define what those "established specifications" are, nor does it provide quantitative performance data for OSTEON II.

2. Sample size used for the test set and the data provenance:

• Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of diagnostic device performance. The performance data presented are for laboratory-based biocompatibility and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. This document does not pertain to an AI/diagnostic device that would require expert-established ground truth.

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

• Not applicable/Not provided.

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/Not provided. This device is a bone grafting material, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

• Not applicable/Not provided.

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

• Not applicable/Not provided. For the biocompatibility and bench tests, the "ground truth" would be the established scientific methods and standards (e.g., ISO standards) that define what constitutes a passing result for cytotoxicity, pyrogenicity, material composition, etc.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not applicable/Not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document details two types of studies used to support the substantial equivalence of OSTEON II:

1. Biocompatibility Testing:

   • Purpose: To evaluate the biological safety of the proposed device's materials.
   • Methodology: Followed the Blue Book memorandum G95-1 and ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing."
   • Specific Tests Conducted: ISO Cytotoxicity, ISO Pyrogenicity, ISO Intracutaneous reactivity, ISO Ames, ISO Systemic toxicity, ISO Sensitization, ISO Implantation, ISO Micro-nucleus.
   • Results: "The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use." (No quantitative results or specific acceptance criteria are provided, only a statement of conformance).

2. Performance Bench Testing:

   • Purpose: To confirm the physical and chemical characteristics of the OSTEON II device.
   • Specific Tests Conducted: -Ca/P ratio, -Crystalline Phase Compositions, -Porosity, -Water Solubility Test, -Density, -Crystallinity Value.
   • Results: "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use." (Again, no quantitative results or specific acceptance criteria are provided, only a statement of conformance to "established specifications").

Conclusion from the document: Based on these tests, the manufacturer concludes that OSTEON II is substantially equivalent to the predicate device OSTEON. The FDA's letter concurs with this determination for the stated indications for use.

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