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VITOMATRIX is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

• 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).

VITOMATRIX is a resorbable bone grafting material composed of β-Tricalcium Phosphate intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile and available in .2 1mm and 1-2mm morsel sizes.
VITOMATRIX guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When VITOMATRIX is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

This is a 510(k) summary for VITOMATRIX, a resorbable bone grafting material. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, it does not fit the typical format for describing acceptance criteria and study results for an AI/ML powered device. The information provided pertains to a traditional medical device (bone graft material), not a software or AI-powered system that would have performance metrics like sensitivity, specificity, accuracy, or AUC.

Therefore, many of the requested fields are not applicable to the provided input. I will extract the information that is present and note when specific requested information is not available in the document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format typically used for AI/ML devices (e.g., target sensitivity, specificity). Instead, it mentions that the device "satisfies the requirements of ASTM F 1088-04a, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation" and that "Data supplied demonstrates that VITOMATRIX is substantially equivalent to the predicate devices and any differences do not raise new questions of safety and effectiveness."

The "performance" described is in terms of physical, chemical, and biological properties, as well as resorption rates and bone healing, rather than diagnostic accuracy.

Since this is not an AI/ML device, the following points regarding AI/ML device studies are largely Not Applicable (N/A) based on the provided text.

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

• Sample Size:
  • Animal Performance Testing: Adult mongrel dogs (number of animals not specified). Bilateral rabbit tibial defect model (number of rabbits not specified).
  • Data Provenance: N/A (animal studies, not human patient data with country of origin). The studies appear to be prospective animal 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)

• N/A. Ground truth for animal studies would typically be based on histological analysis, imaging, and gross observations by veterinary pathologists and researchers, rather than human expert interpretation of diagnostic images in the context of an AI/ML device. The document does not specify the number or qualifications of such experts.

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

• N/A. This concept is relevant for reconciling discrepancies in human expert labeling for AI/ML ground truth. For animal studies evaluating material performance, evaluation methods would follow standard veterinary and pathology protocols. The document does not describe an adjudication method for ground truth in this context.

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

• N/A. This is a material science and biocompatibility study, not an AI-assisted diagnostic study involving human readers.

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

• N/A. This question refers to an AI algorithm's standalone performance. VITOMATRIX is a physical device, not an algorithm.

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

• Pathology/Histology/In-vivo observation: For the animal studies, the "ground truth" would be established through histological examination of the tissue, bone growth, and material resorption, alongside macroscopic observation and potentially imaging (e.g., radiography) to assess bone healing and material integration.

8. The sample size for the training set

• N/A. This device does not involve a "training set" in the context of AI/ML.

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

• N/A. This device does not involve a "training set" in the context of AI/ML.

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