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OCS-B Collagen® is recommended for:

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

OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B") and 10% collagen in a block form in a blister and cylinderic form in a syringe and blister. It is sterilized by yirradiation.

The provided text describes the OCS-B Collagen® device, a bone grafting material, and its substantial equivalence to predicate devices, primarily Bio-Oss Collagen®. The information requested falls under the category of performance testing for medical devices, which typically includes detailed studies to prove efficacy and safety. However, this document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to existing legally marketed devices rather than performing extensive novel clinical trials as would be required for a novel device or a PMA.

Therefore, the study described here is primarily a comparative study against predicate devices, supported by biocompatibility testing and animal studies, rather than a standalone clinical efficacy study with specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of quantitative performance metrics (e.g., specific percentages for success rates, bone growth, etc.). Instead, the acceptance criteria are implicitly that the OCS-B Collagen® device is "substantially equivalent" to its predicate devices (Bio-Oss® Collagen and OCS-B®) in terms of:

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

• Animal Studies: "several animal studies" are mentioned, but no specific sample sizes or species are provided in this summary document.
• Clinical Case Series: "a clinical case series" is mentioned, but no specific number of patients (sample size) is provided.
• Data Provenance: Not explicitly stated for animal studies or the clinical case series (e.g., country of origin, retrospective/prospective). However, the sponsor is NIBEC Co., Ltd. from Korea. Given the K-number, the submission is to the U.S. FDA, so the data would have been submitted to the U.S. regulatory body. The document does not specify if these studies are retrospective or prospective.

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

This type of information is generally not applicable to the studies described for this device. The "ground truth" here is the biological and clinical outcome (bone formation, resorption, defect healing, suitability for implant placement), which would be assessed by standard histological, imaging, and clinical follow-up methods by trained professionals (e.g., veterinarians for animal studies, dentists/oral surgeons for clinical case series). The document does not specify an "expert panel" for establishing ground truth in the context of, for example, image interpretation.

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) summary. Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret data (e.g., images) and consensus is needed, often in AI comparative effectiveness studies. The studies mentioned here focus on biological outcomes rather than interpretive tasks.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted as described in this summary. The comparison is between the device and predicate devices based on physical/chemical properties, biocompatibility, and general performance in animal studies and a clinical case series, not a comparative study of human reader performance with and without AI assistance.

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

This refers to an AI algorithm's performance, which is not relevant for this bone graft material. The device itself is a physical implant, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth used in the animal studies and clinical case series would be based on:

• Histology: Direct examination of tissue to confirm new bone formation and resorption.
• Imaging: X-rays, CT scans, or other imaging modalities to assess defect healing and bone density/volume.
• Clinical Outcomes: Assessment of defect healing, absence of adverse events, and functional outcomes, such as successful dental implant placement.

8. The Sample Size for the Training Set

Not applicable. This device is a physical bone graft, not a machine learning algorithm requiring a training set.

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

Not applicable, as there is no training set for a machine learning algorithm.

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OCS-BTM cancellous and cortical granules are recommended for:

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

OCS-B™ is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria is a compilation of data supporting substantial equivalence to the predicate device, Bio-Oss®. Specifically, the submission highlights:

• Chemical and Physical Characterization: OCS-B™ and Bio-Oss® were found to be comparable in their physical and chemical characteristics.
• Animal Studies: Multiple animal studies showed both products promoted new bone growth and were resorbed at similar rates.
• Clinical Case Series: A summary of seven individual case studies demonstrated defect healing and new bone formation sufficient for dental implant placement using OCS-B™.
• Biocompatibility Testing: OCS-B™ underwent a full range of biocompatibility tests according to FDA's "Class II Special Controls Guidance Document: Dental Bone Grafting Devices" and ISO 10993.
• Risk Control Measures: Validation of TSE inactivation, virus clearance, analysis of residual solvent, risk analysis, and cleaning validation were conducted.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Clinical Case Studies: 7 individual case studies for OCS-B™.
  • Animal Studies: "Several animal studies" were conducted. The exact number of animals or studies is not specified.
  • Biocompatibility Testing: Not specified, but a full range of tests indicates multiple samples/groups would have been used for each test.
• Data Provenance:
  • The document implies data was generated directly by the sponsor or their contracted labs for OCS-B™.
  • The origin (e.g., country) of the animal studies and biocompatibility testing is not specified.
  • The clinical case studies are presented. While the country isn't explicitly stated, the sponsor is based in Korea.
  • The data is retrospective for the clinical case series, as they are presented as a summary of existing cases rather than from a prospective clinical trial. The animal studies and biocompatibility testing would have been specifically conducted for the submission, making them prospective in nature.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Clinical Case Studies:
  • Experts: Not explicitly stated how many experts established the ground truth. However, the report mentions "histological evaluation" and "radiographs," implying examination by qualified dental/medical professionals.
  • Qualifications: Implied to be dental/medical professionals capable of interpreting radiographs and performing histological evaluations for assessing bone growth and defect healing. Specific qualifications (e.g., years of experience, specific certifications) are not detailed in the summary.
• Animal Studies: The experts involved in assessing bone growth and resorption in animal studies are not specified.

4. Adjudication Method (Test Set)

• Adjudication Method: Not specified for any of the studies mentioned. The clinical case series provides "histological and radiographic images demonstrate new bone growth," suggesting perhaps a single expert's assessment per case or an internal review without explicit mention of formal adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through physical/chemical comparison, animal studies, and a clinical case series, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• No, a standalone (algorithm only) performance study was not done. The device (OCS-B™) is a physical bone grafting material, not an AI algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• Clinical Case Studies:
  • Expert Consensus/Pathology/Imaging Data: Ground truth was established through a combination of histological evaluation (pathology) from core biopsies and interpretation of radiographs (imaging data), confirming new bone growth and defect healing.
• Animal Studies: Ground truth for bone growth and resorption would have been based on similar methodologies, including histological analysis and potentially imaging or quantitative analysis of bone volume.
• Biocompatibility Studies: Ground truth is based on established biological endpoints and validated assays (e.g., cell viability, immune response, genotoxicity, systemic toxicity, implantation site reaction).

8. Sample Size for the Training Set

• Not Applicable. OCS-B™ is a physical bone grafting material, not a software algorithm that requires a "training set" in the context of machine learning. The studies described are for validation and characterization of the material itself.

9. How Ground Truth for the Training Set was Established

• Not Applicable. As mentioned above, this is a physical medical device, not an AI/ML algorithm requiring a training set.

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