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THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:

• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of maxillary sinus floor

THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA). THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency. THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.

The provided document is a 510(k) summary for "THE Graft Bone Substitute". It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results for standalone performance.

Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific effect sizes, training set size, and detailed ground truth establishment for the training set, is not available within this document. This document is a summary of regulatory submission, not a scientific publication detailing performance studies.

However, based on the information available, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document states, "All of the acceptance criteria were met" for the performance data. While the specific numerical acceptance criteria for each test are not explicitly detailed, the studies conducted and their purpose are mentioned. The general acceptance criterion is compliance with the referenced standards and guidance documents.

Study Details

1. Sample sizes used for the test set and data provenance:

• Not explicitly stated in the provided document. The document mentions "in-vivo dog model" and "Clinical data" were provided but does not specify the number of animals or human subjects, nor their geographical origin.

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

• Not applicable / Not explicitly stated. For mechanical, physical, biocompatibility, and sterilization tests, the "ground truth" is typically defined by adherence to established international standards (e.g., ASTM F1581, ISO 10993, ISO 11137). For the in-vivo and clinical evaluations, the ground truth would be determined by the study's endpoints (e.g., bone formation, material resorption) assessed by qualified personnel, but the number and qualifications of experts involved in this assessment are not provided.

3. Adjudication method for the test set:

• Not applicable / Not explicitly stated. This type of adjudication (e.g., 2+1) is typically relevant for studies involving subjective human interpretation of data (e.g., imaging reads). The performance data cited are primarily objective laboratory and animal/clinical study results.

4. 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:

• Not applicable. This device is a bone substitute material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

• Not applicable. This is a medical device (bone substitute), not an algorithm or software. Its "standalone performance" refers to its inherent physical, chemical, and biological properties, which were assessed through the listed performance tests (mechanical, physical, biocompatibility, sterilization, viral inactivation) and in-vivo/clinical evaluations.

6. The type of ground truth used:

• For Mechanical and Physical testing: Compliance with ASTM F1581 Standard Specification.
• For Biocompatibility testing: Compliance with ISO 10993 series of standards.
• For Sterilization: Compliance with ISO 11137-1 and ISO 11137-2.
• For Viral Inactivation: Successful inactivation of viruses, which would be measured against specific validated viral assays.
• For In-vivo dog model and Clinical data: Likely pathology (histological assessment of bone formation and material resorption) and potentially outcomes data (e.g., successful integration, absence of adverse events). The specific endpoints are not detailed.

7. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical medical device and not a machine learning model.

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

• Not applicable. As above, no training set for this type of device.

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EQUIMATRIX™ 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, apicoectomy, 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).

EquiMatrix™ is a sterile, natural, non-antigenic, porous bone mineral matrix produced by the removal of organic compounds from equine bone. Due to its natural structure EquiMatrix™ is physically and chemically comparable to the mineralized matrix of human bone. The anorganic bone matrix of EquiMatrix™ has a macro and microporous structure similar to human bone. The formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by v-irradiation.

The provided document is a 510(k) summary for the EquiMatrix™ Natural Bone Mineral Matrix. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, Bio-Oss®.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The document does not describe an AI/ML device. It is a regulatory submission for a medical device (bone grafting material) that is a physical product, not a software algorithm. Therefore, many of your specific questions related to AI/ML device performance (like sample sizes for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training sets) are not applicable to this document.

However, I can extract information related to the device's "performance" and "acceptance criteria" as understood in the context of this biological material.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically demonstrating equivalence to a recognized standard or predicate device in terms of material properties, biocompatibility, and intended biological function (e.g., bone formation). The document argues for substantial equivalence to Bio-Oss®.

Since this is a non-AI/ML device, the following points are not applicable or cannot be extracted from the document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as this is not an AI/ML device. The document mentions "several animal studies" and a "clinical case series" but does not provide sample sizes or data provenance details for these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is not an AI/ML device. Ground truth, in a clinical sense for this device, would be histological analysis of bone growth, clinical outcomes (implant placement success), and assessment of defect healing, typically done by attending clinicians or pathologists, but not "experts establishing ground truth for a test set" in the AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the biological performance of the device (bone formation), the document implies:
  • Histological assessment: Implied by "formation and in-growth of new bone," likely from the animal studies.
  • Clinical outcomes data: Mention of "defect healing and formation of new bone of sufficient quality to obtain dental implant placement" from the "clinical case series" suggests clinical assessment of surgical sites and successful subsequent treatment.
  • Physico-chemical characterization: Ground truth for material properties (composition, morphology) is established through analytical techniques like XRD, FT-IR, ICP analysis.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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