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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
• 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 conjuncts 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.

Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.

The document describes a 510(k) premarket notification for a medical device called "Anorganic Bone Mineral in Delivery Applicator". It does not describe a study involving an algorithm or AI.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set sample size, ground truth for training set) are not applicable to this document.

However, I can provide the acceptance criteria and demonstrated performance based on the non-clinical testing described.

1. Table of acceptance criteria and the reported device performance

Additional Non-Clinical Performance Testing:

• Biocompatibility of Sterile Finished Device: Cytotoxicity, irritation, and sensitization tests were performed and demonstrated biocompatibility. (Specific acceptance criteria for these individual tests are not detailed, but the conclusion states they were met.)
• Biocompatibility of Delivery Applicator: Cytotoxicity, physicochemical attributes of a polymeric material, and USP physicochemical tests were performed. (Specific acceptance criteria not detailed, but the conclusion states they were met.)
• Biocompatibility of Anorganic Bone Mineral: Cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, and subacute/subchronic toxicity tests were performed. (Previously submitted and deemed applicable, conclusion states they were met.)
• Sterilization Validation: Performed in accordance with ISO 11137-1. (Implies meeting the SAL 10^-6 requirement.)
• Bench Testing of Delivery Applicator Functionality and Customer Assessment: Performed. (Implies proper functioning of the applicator.)
• Animal Performance Testing:
  • Anorganic Bone Mineral (derived from porcine bone tissue): Tested in an intraoral defect in a canine model.
  • Anorganic Bone Mineral with and without Collagen: Tested in a rabbit femoral condyle defect model.
    (These studies supported the performance of the bone mineral component, which is part of the subject device.)

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

Not applicable, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study. The relevant "tests" involved laboratory-based biocompatibility, sterilization validation, and bench testing, as well as animal studies. The sample sizes for these specific non-clinical tests (e.g., number of animals, number of test samples for material characterization) are not detailed in this summary.

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 document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study requiring expert-established ground truth.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable, as this document describes non-clinical performance testing not requiring a clinical "ground truth" as typically defined for diagnostic AI. The "ground truth" for these tests would be the established scientific standards and methods for assessing material properties, biocompatibility, and sterility.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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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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