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Synthetic Mineral - Collagen Bone Graft Matrix 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 periodontal defects .
• Filling of defects after root resection, apicocectomy, 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

Synthetic Mineral -- Collagen Bone Graft Matrix is a composite of synthetic calcium phosphate based granules and type I collagen. The calcium phosphate mineral has an apatite structure similar to that of natural bone. The type I collagen is derived from bovine Achilles tendon. The composite material is a resorbable, porous, osteoconductive bone graft matrix. The product is supplied in granular or block/plug form, and it is sterile, non-pyrogenic, and for single use only.

The provided text describes a 510(k) premarket notification for a medical device called "Synthetic Mineral - Collagen Bone Graft Matrix." This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving effectiveness through a standalone clinical study with specific acceptance criteria that lead to performance metrics, as would be typical for a new device.

Therefore, the specific details requested in the prompt, such as acceptance criteria based on performance studies, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth methodologies, are not explicitly present in this type of submission.

Instead, the "effectiveness" section states: "The characteristics of the Synthetic Mineral – Collagen Bone Graft Matrix meet the design requirements for an effective bone grafting material in dental surgery." This implies that the device's inherent properties and its resemblance to predicate devices are considered sufficient to meet the general design requirements for bone grafting materials.

Here's how the available information relates to your request:

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

2. Sample size used for the test set and the data provenance:

• Not Applicable. The submission does not describe a clinical study with a "test set" in the context of device performance metrics. Its effectiveness is based on material characteristics and comparison to predicate devices, not on direct clinical performance data from a specific patient cohort for performance evaluation.

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

• Not Applicable. The submission does not involve a "test set" for which ground truth would be established by experts.

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

• Not Applicable. There is no "test set" or adjudication method described.

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-powered diagnostic device, and therefore, an MRMC study with human readers assisting or being assisted by AI is not relevant to this submission.

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

• Not Applicable. This device is a bone grafting material, not an algorithm.

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

• The "ground truth" in this context is based on the established regulatory standards for biocompatibility (FDA Blue Book tests) and the material characteristics that are demonstrably similar to legally marketed predicate devices. There is no "ground truth" derived from patient outcomes or expert consensus on diagnostic interpretations for this type of device.

8. The sample size for the training set:

• Not Applicable. The submission does not describe a "training set" in the context of machine learning or an algorithm.

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

• Not Applicable. See point 8.

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BoneMedik-DM is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects, in particular in periodontal or oral/maxillofacial application. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product may be used in surgical procedures such as:

• Augmentation or reconstructive treatment of the alveolar ridge
• Filling of periodontal defects
• Filling of defects after root resection, apicocectomy and cystectomy
• 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.

BoneMcdik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% ßtricalcium phosphate. The silicon substituted hydroxyl apatite component was cleared for general bone void filling in K070897 by this firm. BoneMedik-DM is an osteoconductive porous implant material which maintains the porous structure of coral and thus is similar in structure to human cancellous bone. The basic material is macroporous and microporous hydroxyapatite and beta tricalcium phosphate, both substances are well known for their bioactivity and ready osseointegration. Both substances are also well known for their excellent bone filler and growth properties. Once implanted, the porous hydroxyapatite and ß tricalcium phosphate are resorbed and the reticulated spaces in the implant material are infiltrated with tissue. Bone formation occurs in apposition to the BoneMedik-DM surfaces and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant. BoneMedik-DM is supplied as granules ranging in size from 0.1 to 2.0 mm. Vials of the powder are available in amounts of 0.25g, 0.5g, 1g, and 2g. The vials are of polyethylene sealed in pouches formed one side of medical grade Tyvek one side polyethylene

The provided text describes a 510(k) summary for a medical device called "BoneMedik-DM." This document focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing acceptance criteria and proving performance through a standalone clinical study with specific metrics.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods is not available in the provided text, as these are typically characteristics of a clinical trial or performance study, not a 510(k) substantial equivalence submission for this type of device.

However, I can extract the information that is present and indicate where information is missing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., specific success rates, fusion rates, bone density changes). Instead, the primary "acceptance criteria" for a 510(k) submission like this is Substantial Equivalence to legally marketed predicate devices. This is established by demonstrating equivalent intended use, technological characteristics, and safety and effectiveness.

Reported Device Performance:
The "performance" is demonstrated through a series of tests and comparisons to predicates, rather than quantifiable clinical outcome measures in the general sense.

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

• Sample Size for Test Set: Not explicitly stated in terms of a clinical study or human trial. The "test set" primarily refers to:
  • Material characterization (composition, structure).
  • Biocompatibility tests (following ISO 10993).
  • Sterility tests (following ISO 11137).
  • Animal testing: Mentioned ("Animal testing was conducted...") but no details on the number of animals or specific experimental design are provided.
• Data Provenance:
  • Biocompatibility & Sterility: Likely laboratory testing, likely internal to the manufacturer or conducted by certified labs.
  • Animal Testing: Conducted by the manufacturer or a contracted lab. No country of origin for the animal study data is specified beyond the manufacturer's location (Republic of Korea).
  • Retrospective or Prospective: Not applicable in the context of this 510(k) summary, as it's not a human clinical trial. The animal study would be prospective.

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

• Not applicable / Not provided. The device's "ground truth" for demonstrating substantial equivalence relies on established international standards (ISO), material science analyses, and comparison to previously cleared devices. There is no mention of human experts interpreting image data or clinical outcomes for a specific "test set" in the way an AI/CADe device would require.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. As there's no mention of human experts providing ground truth for a diagnostic test set, an adjudication method is not relevant here.

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 is a bone grafting material, not an AI/CADe device. An MRMC study is not relevant.

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

• No. This is a bone grafting material, not an AI/CADe device. A standalone algorithm performance study is not relevant.

7. The type of ground truth used

• Physicochemical and Biological Standards: The primary "ground truth" is adherence to international standards for medical device safety and performance (e.g., ISO for biocompatibility and sterility) and demonstrated equivalence of material properties and biological behavior (via animal studies) to legally marketed predicate devices.
• Predicate Device Characteristics: The characteristics and regulatory clearance of the numerous predicate devices listed serve as a "ground truth" for the substantial equivalence claim.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

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

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

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