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Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.

Porcine Mineral Collagen Composite is indicated for:

• Augmentation or reconstructive treatment of 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).

Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.

The product is available in the following shape and sizes:

This document describes the performance data for a medical device called "Porcine Mineral Collagen Composite" in the context of its 510(k) premarket notification to the FDA. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence through various performance tests rather than against explicit numerical "acceptance criteria" in the way one might see for an AI algorithm's sensitivity/specificity. However, the outcomes of these tests effectively serve as the criteria for acceptance to demonstrate equivalence to the predicate device.

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

• Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of guinea pigs for sensitization, number of mice for acute systemic toxicity) are not explicitly stated in the summary. The tests were performed in vitro (e.g., L929 MEM Elution) and in vivo (e.g., Guinea Pig Maximization, Rabbit Intracutaneous Reactivity, mice for systemic toxicity, canine for implantation).
• Bench Testing: Sample sizes for each bench test are not specified. These tests are inherently in vitro.
• Animal Testing (Canine Study): The sample size (number of canines) for the intrabony defect model is not specified. The study was in vivo, involving implantation at 4, 8, and 13 weeks. Its provenance is not stated (e.g., specific country or institution), but it's an animal study conducted to demonstrate performance.
• Data Provenance: The document does not explicitly state the country of origin for the data for any of the studies, nor does it explicitly classify them as "retrospective" or "prospective" as one would for human clinical trials. However, given the nature of the studies (biocompatibility, bench, animal), they would generally be considered prospective studies designed to evaluate the device.

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

This level of detail is not provided for most tests.

• Animal Testing (Canine Study): Radiographic, Micro CT, Histology, and Histomorphometry analyses were conducted. While these analyses require expert interpretation (e.g., veterinary pathologists, radiologists), the number of experts and their specific qualifications are not specified in this summary. The "ground truth" here is derived from the scientific measurements and observations from these analyses compared to a predicate device and sham control.
• For in vitro and other standardized tests (e.g., cytotoxicity, pyrogenicity), the "ground truth" is typically the result of the standardized test itself, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable or specified for the types of tests conducted. These are not studies requiring human expert adjudication of ambiguous cases, as would be common for AI in medical imaging. The studies focus on objective measurements and established biological responses.

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 type of study (MRMC for AI assistance) was not performed because:

• The device is a medical implant (bone graft material), not a software or AI-driven diagnostic tool.
• "Clinical performance data was not required to determine substantial equivalence" (Page 8), meaning human clinical trials comparing device performance or AI assistance were not deemed necessary for this 510(k) submission.

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

No. This question is also specifically relevant for AI algorithms. The "Porcine Mineral Collagen Composite" is a physical device, so the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluation of this device is established through a combination of:

• Standardized Test Results/Reference Values: For biocompatibility tests (e.g., non-cytotoxic, non-mutagenic), specific thresholds or qualitative outcomes defined by recognized standards (ISO, USP) serve as the ground truth.
• Predicate Device Equivalence: For many bench tests (e.g., mineral content, calcium to phosphate ratio, porosity, pH), the "ground truth" is similarity to the legally marketed predicate devices, as the goal is to demonstrate substantial equivalence.
• Pathological/Histological Findings: In the canine intrabony defect model, ground truth is derived from objective measurements (e.g., radiographic density, Micro CT analyses) and expert evaluation of tissue samples (histology, histomorphometry) for parameters like tissue reaction, new bone formation, etc.

8. The Sample Size for the Training Set:

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable.

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

As there is no training set for an AI model, this question is not applicable. The device's characteristics are inherent to its manufacturing process and tested through established laboratory and animal study protocols.

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