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InterOss® small granules are recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge .
• . Filling of infrabony periodontal defects
• . Filling of defects after root resection, apicocectomy, and cystectomy
• . Filling of extraction sockets to enhance preservation of the alveolar ridge
• . Elevation of the 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)

InterOss® large granules are recommended for:

• . Augmentation or reconstructive treatment of the alveolar ridge
• . Elevation of the maxillary sinus floor
• . Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process.

InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.

InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).

InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).

The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.

During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.

All InterOss® products are supplied sterile and are intended for single use only.

The provided text describes the regulatory clearance of a bone grafting material called InterOss® and does not contain information about a medical device that relies on AI or offers performance metrics that would typically be described with acceptance criteria like sensitivity, specificity, or AUC, as commonly seen in AI/ML device descriptions.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" here are implied by the standards for bone grafting materials and the equivalence to the predicate devices.

Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" as the properties and test outcomes required for substantial equivalence in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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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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