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Grafton™ DBM and Grafton Plus ™ DBM Paste are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space (excluding Flex or Crunch), pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. When used in intervertebral body fusion procedures, Graft™ DBM (excluding Flex or Crunch) and Grafton Plus ™ DBM Paste must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Grafton™ DBM and Grafton Plus™ DBM Paste are absorbed/remodeled and replaced by host bone during the healing process.

Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, pelvis and extremities) not intrinsic to the stability of the bony structure. Voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.
Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile water in order to adjust consistency and handling of bone graft material.
When used in intervertebral body fusion procedures, Magnifuse™ Bone Graft must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Magnifuse™ Bone Graft is resorbed/remodeled and is replaced by host bone during the healing process.

The Grafton™ DBM, Grafton Plus™ DBM Paste, and Magnifuse™ Bone Graft devices in this submission are human bone products containing human demineralized bone matrix (DBM).

Grafton™ DBM is a human bone product that contains human DBM with an inert additive. Grafton™ DBM is produced in particular physical forms (Grafton™ DBM Gel, Grafton™ DBM Putty, Grafton™ DBM Matrix, Grafton™ DBM Orthoblend) and/or handling property. Grafton™ DBM is provided in ready-to-use form and is intended in single patient, single use containers. Grafton™ DBM is identical to the device cleared in K051195.

Grafton Plus™ DBM Paste is human demineralized bone matrix combined with an inert additive to yield a product having a particular physical form and/or handling property. Grafton Plus™ DBM Paste is identical to the device cleared in K043048.

Magnifuse™ Bone Graft is a human bone allograft product containing human DBM and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. It is intended for use in filling bony voids or gaps or the skeletal system not intrinsic to the stability of the bony structure. Magnifuse™ Bone Graft is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use. Magnifuse™ Bone Graft is identical to the device cleared in K082615.

This FDA 510(k) clearance letter (K251193) is for bone graft materials (Grafton™ DBM, Grafton Plus™ DBM Paste, Magnifuse™ Bone Graft) and does not describe an AI/software device or a study with "acceptance criteria" based on AI performance metrics like sensitivity, specificity, or reader studies.

The document details the substantial equivalence of new product formulations/expanded indications for use to previously cleared predicate and reference devices. The "performance" section refers to pre-clinical testing and leveraging prior clearances for bone graft characteristics (e.g., DBM properties, viral inactivation, shelf-life, biocompatibility in animal models, etc.), not a clinical study involving human readers or AI algorithm performance.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI device acceptance criteria and performance studies. The document does not contain:

• A table of acceptance criteria and reported device performance for an AI system.
• Sample sizes for a test set, data provenance, or expert ground truth establishment for an AI study.
• Details on MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Description of ground truth type for an AI system.
• Training set sample size or how ground truth for training was established for an AI system.

The "Performance" section explicitly states: "The devices' performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies." This refers to biological and mechanical performance of the bone graft materials themselves, not an AI software.

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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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Grafton Plus® DBM Paste is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Grafton Plus® DBM Paste is resorbed/remodeled and is 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) to which an inert starch-based carrier has been added. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. 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 a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay.

The provided text describes the GRAFTON PLUS® DBM Paste, a demineralized bone matrix allograft. The study supporting its safety and effectiveness is primarily based on animal bone formation studies and the product's osteoinductive properties.

Here's an analysis of the acceptance criteria and study in relation to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated numbers for animals used in the bone formation studies. It mentions "ongoing testing" but not specific sample sizes for the "test set" in a traditional sense. The athymic rat assay is used for ongoing product and process consistency confirmation.
• Data Provenance: Animal studies (athymic rat assay). No country of origin is specified for the animals. The studies are retrospective in the sense that the results are being reported after completion, but the "ongoing testing" suggests continuous evaluation.

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

• Experts: Not explicitly stated within the provided text. The osteoinductivity assay uses a "five-point linear scale (0,1,2,3,4) to score bone formation." This implies expert scoring, but the number and qualifications are not detailed. The referenced publication (Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD) suggests that experts with relevant scientific backgrounds (PhD, MS) were involved in developing or executing the method.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The use of a "five-point linear scale" suggests a standardized scoring method, but details on inter-rater reliability or adjudication of discrepancies are not provided.

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

• MRMC Study: No. This device is a biomaterial (demineralized bone matrix paste), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Yes, in an analogous sense for a device of this type. The performance of the GRAFTON PLUS® DBM Paste itself (e.g., its osteoinductive capacity, comparable performance to autograft) was evaluated directly in animal studies, without human intervention in the "performance" aspect of the paste. The scoring of the results (e.g., bone formation) would involve human observation and assessment, but the device's action is independent of a human-in-the-loop directly influencing its biological outcome.

7. The Type of Ground Truth Used

• Ground Truth: In the context of bone formation:
  • Expert Scoring/Histological Evaluation: The five-point linear scale for bone formation in the athymic rat assay heavily relies on expert assessment of tissue samples (histology).
  • Comparative Performance: Comparison to "autograft" performance serves as a ground truth benchmark for effective bone healing. Autograft is often considered the gold standard for bone regeneration.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not explicitly stated. The product is described as being prepared via a "proprietary processing method... that has been validated to consistently produce DBM that is osteoinductive." This validation process would implicitly involve a "training" or development phase to achieve consistency, but specific sample sizes for this phase are not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth (Training Set): Implied through the "validation" of the proprietary processing method. The ground truth for the processing would be established by demonstrating that the resulting DBM consistently exhibits osteoinductivity as measured by the athymic rat assay (i.e., achieving specific scores on the 5-point scale). This would involve iterative testing and refinement of the processing method until the desired osteoinductive outcome is reliably achieved.

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