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GRAFTON PLUS®DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodelled and replaced by host bone during the healing process.

GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON PLUS® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume. GRAFTON PLUS® DBM Paste is an osteoinductive bone graft product in that it forms ossicles of bone when implanted ectopically in an athymic rat model. It is produced using a process that has been validated to consistently produce osteoinductive DBM as measured in the athymic rat test model.

The provided text is a 510(k) summary for a medical device called GRAFTON PLUS® DBM Paste, which is a demineralized bone matrix (DBM) allograft. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's intended use and performance, primarily in an animal model.

Based on the provided information, I can extract details related to performance and the study conducted, but it does not include the typical acceptance criteria and detailed study design characteristics found in studies evaluating AI/ML-based diagnostic devices. This document describes a traditional medical device (biological material), not a software or image analysis device. Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in the context of this device's regulatory submission.

Here's a summary of the information that can be extracted, and explanations for why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The study involved an "athymic rat model," but the number of rats or samples tested is not provided.
• Data Provenance: Not explicitly stated, but performed in an "athymic rat model," implying an animal study rather than human clinical data. The study is prospective in nature as it involves implanting the device into animals and observing outcomes.

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

• Not Applicable. This is a biological material, not an image-based diagnostic or AI device. Ground truth is established through histological examination of tissue, not expert interpretation of images. The assessment of ossicle formation would be done by trained histologists/pathologists, but the number and their qualifications are not detailed in this summary.

4. Adjudication method for the test set:

• Not Applicable. See explanation for #3.

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-based device, so an MRMC study related to human reading performance with or without AI assistance is irrelevant.

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

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

7. The type of ground truth used:

• Histological observation of bone formation. The text states: "...it forms ossicles of bone when implanted ectopically in an athymic rat model." This indicates that the ground truth for "osteoinductivity" is the direct observation of new bone formation (ossicles) in the animal tissue, typically confirmed through microscopy and histological staining.

8. The sample size for the training set:

• Not Applicable. As a traditional medical device, there is no "training set" in the context of machine learning. The "process that has been validated to consistently produce osteoinductive DBM" implies quality control and process validation, but not a data-driven training set for an algorithm.

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

• Not Applicable. See explanation for #8.

Study Description and Purpose:

The study referenced is an animal model study using athymic rats.

• Purpose: To demonstrate the osteoinductive potential of GRAFTON PLUS® DBM Paste, meaning its ability to induce new bone formation. This is a critical characteristic for demineralized bone matrix products.
• Methodology: The device material was implanted ectopically (meaning in a location where bone typically does not form naturally, such as muscle tissue) in athymic rats. The formation of "ossicles of bone" was then observed.
• Outcome: The study "demonstrated consistent bone formation with GRAFTON PLUS® DBM Paste" and validated that the manufacturing "process... has been validated to consistently produce osteoinductive DBM."

This submission is a 510(k), which aims to demonstrate "substantial equivalence" to legally marketed predicate devices. The performance data is used to support that the device functions as intended and is safe and effective in a manner comparable to its predicates, especially regarding its osteoinductive properties.

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