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InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge

Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), 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. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.

The product is available in the following shapes and sizes:

The provided document is a 510(k) premarket notification for the InterOss® Collagen bone grafting material. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning device. The "acceptance criteria" and "device performance" in the tables are for the physical and chemical properties and biocompatibility of the bone grafting material itself, not for an AI-powered system evaluating its efficacy or providing diagnostic information.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a traditional medical device (bone grafting material), not an AI/ML medical device, and thus the requested AI-specific information is not present.

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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

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

• Animal study (in-vivo performance): 4 treatment groups of beagle dogs. Three groups of nine dogs, and one group of six dogs. This refers to the study conducted on the device itself, not an AI test set.
• Data Provenance: The animal study was conducted by SigmaGraft, Inc. (the manufacturer) or on their behalf, in the USA (presumably, as the FDA submission is from a US company). It is a prospective animal study as described (surgical procedures, observations, termination points).

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

• Animal study (histology/pathology): Histological analysis was performed by Alizée Pathology, LLC. The specific number and qualifications of experts (e.g., veterinary pathologists with X years of experience) are not detailed in this summary.

4. Adjudication method for the test set:

• The document does not describe an adjudication method for human reader interpretations. The evaluation methods for the animal study (micro-CT, semi-quantitative histology scoring, histomorphometry) are objective measurements.

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:

• No. This document describes a medical device (bone grafting material), not an AI/ML software device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.

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

• No. This document is not about an AI/ML algorithm.

7. The type of ground truth used:

• Animal study (in-vivo performance): A combination of imaging (micro-CT) for mineralized volume/density and histopathology (undecalcified histology with semi-quantitative scoring and histomorphometry) for biocompatibility, tissue response, residual implant, and bone formation. This serves as the "ground truth" for the device's biological performance.

8. The sample size for the training set:

• N/A. This is not an AI/ML device where a "training set" would be applicable. The closest analogy would be prior knowledge and predicate device data used in the design and development of InterOss®.

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

• N/A. As above, this is not an AI/ML device. The "ground truth" for the predicate devices and general scientific understanding of bone grafting materials is based on decades of medical research, clinical experience, and regulatory standards.

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