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Osta Maxigro™ in both forms (powder & blocks) and Osta Regigro™ in both forms (powder & blocks) are Recommended for:
Filling of large oral and maxillofacial intra-osseous cavities.

1. Augmentation or reconstructive treatment of alveolar ridge
2. Filling of periodontal defects
3. Filling of defects after root resection, apicectomy, and cystectomy
4. Filling of extraction sockets to enhance preservation of the alveolar ridge
5. Elevation of maxillary sinus floor
6. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

Osta Maxigro™ and Osta Regigro™ are natural bone minerals which have been derived from a bovine extract. The material is essentially free from collagen and comprises of a highly purified mineral structure with micropores and trabecules which is comparable to that of human bone. The materials are prepared by extracting the fat and removal of the collagen, thereby resulting in a pure bone mineral that is sintered in block form and then crushed to form powder granules. This natural sponge like geometry comprising of Hydroxyapatite nano-crystalls results in a high internal surface area scaffold that typically exceeds 100m /g for Osta Maxigro™ and 80m /g for Osta Regigro™. The high surface area properties of these materials make them ideal for allowing blood flow to the wound site where bony contact is established during the bone remodeling process. Osta Maxigro™ and Osta Regigro™ have low crystallinities comparable to that of human bone which is completely resorbed and replaced by host bone during bone regeneration process. The materials support bone formation but do not induce bone formation. Osta Maxigro™ are available in powder or block form and both undergo final sterilization by y- radiation of Osta Maxigro™ blocks and granules can be utilized for the indications shown below depending on the defect size. Osta Maxigro™ Blocks is ideally recommended for filling of large bone cavities with limited bone height and or wall thickness.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Osta Maxigro™ and Osta Regigro™ devices:

The provided text describes a 510(k) premarket notification for Osta Maxigro™ and Osta Regigro™ (anorganic bovine bone grafting material), claiming substantial equivalence to the predicate device Bio Oss (K033815).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets. Instead, the submission relies on demonstrating similarity and no significant difference compared to the predicate device, Bio Oss (K033815). The "acceptance criteria" are implied to be achieving equivalence to the predicate in key characteristics.

2. Sample Size Used for the Test Set and Data Provenance

• Dissolution Study: The text mentions "no significant difference in the dissolution rates of the devices (in either form powder or block) to the predicate" at 99% confidence, but does not specify the sample size for this test.
• Biocompatibility Studies (in vitro/in vivo): The text mentions these tests were performed and conformed to ISO standards.
  • Cytotoxicity, Intracutaneous Injection, Sensitization, Genotoxicity: These are in vitro or local toxicity tests. The document does not specify the number of samples or batches tested.
  • Implantation Study (in vivo): An "in vivo implantation muscle pouch study" was conducted. The sample size is not specified. Given it's an animal study, the sample size would typically refer to the number of animals.
• Data Provenance: The document does not explicitly state the country of origin for the data (e.g., if the dissolution or implantation studies were performed in South Africa where Osta Technologies is based, or elsewhere). The studies are described in a retrospective manner within the 510(k) submission, confirming tests were completed before submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this submission. The "ground truth" here is the established safety and effectiveness profile of the predicate device (Bio Oss) and the performance standards defined by ISO for various biological and material characteristic tests. The studies are laboratory-based and animal-based, not involving human expert assessment of clinical cases for ground truth.

4. Adjudication Method for the Test Set

This is not applicable. The studies described are objective laboratory and animal tests, not clinical studies requiring human adjudication of results. "Adjudication method" primarily applies to clinical studies where human readers (e.g., radiologists) interpret images or clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices assisting human interpretation of medical images, which is not the nature of this bone grafting material device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as this is a medical device (bone grafting material), not an algorithm or AI software. All performance tests performed are inherently "standalone" in the sense that they assess the material itself without human interpretation as part of a diagnostic or therapeutic workflow.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established benchmarks and scientific principles:

• Predicate Device Performance: The primary ground truth for substantial equivalence is the known performance and safety profile of the legally marketed predicate device, Bio Oss (K033815).
• ISO Standards: International Organization for Standardization (ISO) standards (e.g., ISO 10993 series for biocompatibility, ISO 11137 for sterilization) serve as the ground truth for biological safety tests.
• Scientific Understanding: The understanding that in vitro dissolution rates are indicative of in vivo resorption rates serves as a scientific ground truth for the effectiveness claim.

8. The Sample Size for the Training Set

This is not applicable. This submission describes a physical medical device (bone grafting material), not an AI/ML algorithm that requires a training set. The term "training set" is generally used in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as #8.

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