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OSTEON III 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 (ß-TCP). This product presents an interconnected porous structure, similar to that human cancellous bone. This product is available as irregular shape particle of size 0.2~2.0mm. It is sterilized by gamma-radiation.

The provided text is a 510(k) summary for a medical device called OSTEON III. It describes the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence, but it does not provide the details requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not contain any information about:

1. A table of acceptance criteria and reported device performance for clinical endpoints. It has a table comparing technological characteristics (composition, physical properties) to predicate devices, and lists biocompatibility and performance bench tests conducted, but not acceptance criteria for clinical outcomes.
2. Sample size used for a test set or data provenance for a clinical study. The document only references non-clinical testing.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance. (This device is a bone grafting material, not a software algorithm).
7. Type of ground truth used for a clinical study.
8. Sample size for a training set. (Again, this relates to an algorithm, which OSTEON III is not).
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

• Intended Use and Indications for Use: OSTEON III is for bone grafting to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, similar to its predicates.
• Technological Characteristics: Comparison of main materials (HA and β-TCP), device design (interconnected porous structure), composition, and physical properties (porosity, pore size, particle size, Ca/P ratio, crystallinity).
• Biocompatibility Testing: A list of ISO 10993 tests performed (Cytotoxicity, Sensitization, Pyrogenicity, Intracutaneous reactivity, Systemic toxicity, Subchronic toxicity, Genotoxicity-Ames, Genotoxicity-Micro nucleus, Implantation, Genotoxicity-Chromosomal aberration, Endotoxin (LAL)). The results are stated as showing the materials are non-toxic and non-sensitizing.
• Performance Bench Testing: A list of engineering tests like Visual Test, Size, Capacity, Density, Trace Elements, Ca/P ratio, Crystalline phase Composition, Crystallinity, Morphology & Surface Characteristics, Water Solubility, Elution Test (pH, Pb), Potassium permanganate consumed, Ultraviolet rays absorption spectrum, Resorption, Particle size distribution, Compressive strength, Shear and Elastic modulus. The document states "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON III met the established specifications necessary for consistent performance according to its intended use."

In summary, the provided document is a 510(k) summary for a bone grafting material, not a clinical study report for an AI/software device. Therefore, it does not contain the information requested in your prompt regarding clinical acceptance criteria, study design, or expert consensus details.

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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

Ask a specific question about this device