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Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:

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

Porcine Anorganic Bone Mineral in Delivery Applicator is a porous bone mineral matrix consisting predominantly of calcium phosphate, pre-loaded into a delivery applicator. Porcine Anorganic Bone Mineral in Delivery Applicator is produced by removal of the organic components from porcine bone. Porcine Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The product is non-pyrogenic and for single use only.

This document pertains to a 510(k) premarket notification for a medical device called "Porcine Anorganic Bone Mineral in Delivery Applicator" (K162158). It does not describe an AI/ML device or its performance criteria. Therefore, most of the requested information cannot be extracted.

However, I can provide information about the acceptance criteria and the studies performed to demonstrate substantial equivalence to its predicate device, as presented in the document:

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

The document does not explicitly present a "table of acceptance criteria" with numerical performance metrics for the device itself in the way one would for an AI/ML diagnostic or measurement device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Porcine Anorganic Bone Mineral, K140714) through a comparison of technical characteristics and performance testing.

The "acceptance criteria" are implied by the comparison to the predicate device and the successful completion of specified tests. The "reported device performance" is essentially that the device met the requirements of these tests and was found to be substantially equivalent.

Here's a table based on the provided "Summary/Comparison of Technical Characteristics" and "Non-Clinical Performance Testing" sections, focusing on functional acceptance as being equivalent to the predicate or meeting standard test requirements.

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

The document does not specify a "test set" in the context of an AI/ML algorithm. The performance testing outlined involved:

• Biocompatibility testing: Standardized tests for medical devices. The sample sizes for these tests are not provided but would typically be dictated by the relevant ISO standards (e.g., ISO 10993).
• Sterilization validation: Performed according to ISO 11137-1. Sample sizes are not specified here but are standard for such validations.
• Bench testing: For delivery applicator functionality. No sample size given.
• Animal performance testing: Referenced as being previously submitted for the predicate device in a canine model. The specific sample size or provenance of this animal study is not detailed in this document.

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. This device is not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This device is not an AI/ML diagnostic device requiring expert adjudication.

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. This is not an AI-assisted device.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable for an AI/ML context. However, for a medical device such as this bone mineral, the "ground truth" for its performance is established through:

• In vitro and material characterization: Chemical composition analysis, physical properties, pH, particle size, etc., against defined standards.
• Biocompatibility studies: Demonstrating safety and biological compatibility according to ISO 10993 standards.
• Sterilization validation: Conforming to sterility assurance level (SAL) requirements.
• Animal performance studies: Demonstrating expected biological response and bone regeneration characteristics in a relevant animal model (canine model referenced).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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Porcine Anorganic Bone Mineral is intended for use in dental surgery. The products may be used in surgical procedures such as:

• Augmentation or reconstructive treatment of alveolar ridge
• Filling of infrabony periodontal defects
• Filling of defects after root resection, apicoectorny, and cystectorny
• 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.

Porcine Anorganic Bone Mineral is a porous bone graft material consisting predominantly of calcium phosphate supplied in granular form for use in dental surgeries. The anorganic bone mineral is produced by removal of the organic components from porcine bone. The composition of Porcine Anorganic Bone Mineral meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The anorganic bone mineral matrix is biocompatible, having interconnecting macro- and microscopic porous structure that supports the formation and ingrowth of new bone at the implantation site. The use of Porcine Anorganic Bone Mineral may be considered when autogenous bone is not indicated, or insufficient in quantity to fulfill the needs of the proposed surgical procedure. The granular product is supplied sterile, non-pyrogenic, and for single use only.

The provided text is a 510(k) summary for a medical device (Porcine Anorganic Bone Mineral), not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, much of the requested information, such as sample sizes for test sets, expert qualifications, and details about AI performance, is not present.

However, I can extract information related to the acceptance criteria for the physical properties of the Porcine Anorganic Bone Mineral device and the types of studies conducted to demonstrate its substantial equivalence to predicate devices.

Here's the analysis based on the provided text, focusing on what is available:

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

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. For the material characterization and biocompatibility studies, specific sample sizes are not provided in this summary. For the animal efficacy studies, it mentions "two separate animal efficacy studies," but the number of animals used in each study is not stated.
• Data Provenance:
  • Material Characterization & Biocompatibility: Performed by the applicant, Collagen Matrix, Inc. The location of testing is not specified, but the company address is Oakland, New Jersey, USA.
  • Animal Efficacy Studies: Conducted in "a dog dental intrabony defect model" and "a rabbit femoral condyle defect model." The geographical location of these studies is not specified.
• Retrospective or Prospective: These non-clinical and animal studies are inherently prospective, as they are designed experiments to evaluate the device.

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 requiring expert ground truth for classification. The "ground truth" here is established through objective physical/chemical measurements and biological assessment according to recognized standards and protocols.

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

• Not applicable for a physical device evaluation. Adjudication methods are typically relevant for human interpretation tasks, especially in AI/ML performance evaluation where ground truth might be debatable.

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. 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 consensus, pathology, outcomes data, etc)

• For Material Characterization: The "ground truth" is based on the specifications defined by ASTM F1581, general material science principles, and comparison to the predicate devices. This involves objective physical and chemical testing.
• For Biocompatibility: The "ground truth" is established by adherence to ISO 10993 standards for biological evaluation of medical devices, which includes tests for cytotoxicity, genotoxicity, systemic toxicity, local effects after implantation, carcinogenicity, and reproductive toxicity. The outcome (safe/unsafe) is determined by the results of these standardized tests.
• For Animal Efficacy Studies: The "ground truth" is assessed through the observed biological response in the animal models (e.g., new bone formation, integration) as compared to the predicate device. This would typically involve histological analysis, imaging, and other measures of tissue regeneration and healing.
• For Viral Inactivation: The "ground truth" is established by adherence to ISO 22442 standards, demonstrating that the manufacturing process effectively eliminates or inactivates potential viruses and transmissible agents.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The development of the device itself would involve numerous R&D iterations, but not a formally defined "training set" in the AI sense.

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

• Not applicable. See point 8.

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