Search Results

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.

Ask a specific question about this device

GRAFTON® DBM 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® DBM 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® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

GRAFTON® DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative handling. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON® DBM is provided ready-to-use in various physical forms. It is packaged in various sizes by volume or dimension for single patient use. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay.

This document describes a 510(k) premarket notification for the GRAFTON® DBM (Demineralized Bone Matrix) product. As such, it is not a study proving device meets acceptance criteria in the sense of a clinical trial for a novel AI device. Instead, it is a submission demonstrating substantial equivalence to legally marketed predicate devices, which is a different regulatory pathway.

Therefore, many of the typical questions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness for AI devices are not applicable in this context. The document focuses on demonstrating that GRAFTON® DBM is as safe and effective as existing devices.

However, I can extract the relevant information from the provided text based on the closest applicable concepts:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and performance characteristics (like osteoinductivity for DBM products). "Reported device performance" for DBMs typically refers to their biological properties.

*Note on : The document explicitly states: "This bone forming activity exhibited by GRAFTON® DBM in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance." This highlights that while the assay demonstrates a biological characteristic, it's not a direct measure of clinical success.

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

For the osteoinductivity assay:

• Sample size: Not explicitly stated, but the method describes "ongoing testing of GRAFTON® DBM finished product for osteoinductivity in this validated athymic rat assay". This suggests a continuous testing process rather than a single fixed "test set" in the context of a clinical trial.
• Data provenance: Athymic rat model. This is an animal model, not human data. The specific country of origin is not mentioned, but the associated reference (Edwards et al., 1998) suggests US-based research. Retrospective/prospective is not directly applicable to an ongoing assay of a manufactured product.

For the statement "results of studies in animals and humans show that GRAFTON® DBM performs at least as well as...":

• Sample size: Not specified in this 510(k) summary. These would refer to existing, presumably published or unpublished, studies.
• Data provenance: Mention of "animals and humans" but no further detail on country of origin or retrospective/prospective nature.

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

• For the athymic rat assay: Ground truth (scoring of bone formation) would typically be established by trained laboratory personnel or pathologists specializing in histology. The number of experts and their specific qualifications are not detailed in this summary. The mention of a "five-point linear scale (0,1,2,3,4) to score bone formation" suggests a standardized, objective scoring method.

4. Adjudication method for the test set

• Not specified for the athymic rat assay, nor is it explicitly mentioned for any 'test set' in the context of a human clinical study. Given the nature of a 510(k) summary and the animal model, a formal multi-reader adjudication method as seen in complex clinical imaging trials is unlikely to be detailed 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 document describes a medical device (bone graft material), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• No. This is a medical device, not an algorithm. This question is not applicable.

7. The type of ground truth used

• For the osteoinductivity evaluation: Histological assessment (scoring of bone formation on a five-point scale) in an athymic rat model, based on a validated assay. This is a surrogate marker for human clinical performance.
• For the broader claim of performing "at least as well as" predicates: This would implicitly rely on clinical outcomes data (e.g., fusion rates, healing rates) from animal and human studies, though specific details are not provided in this summary.

8. The sample size for the training set

• This concept is not applicable in the context of a 510(k) for a DBM product. There is no "training set" for an algorithm. The "proprietary processing method" is validated to consistently produce osteoinductive DBM, which implies quality control and process validation, not machine learning model training.

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

• This question is not applicable for the reasons stated in point 8. The "ground truth" for ensuring consistent product quality (i.e., osteoinductivity) is established through the validated athymic rat assay as described in point 7.

Ask a specific question about this device

GRAFTON® DBM 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); surgically created defects or defects created by trauma. The voids or gaps may be large or small and may be unicortical or bicortical. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative use in filling bony voids or gaps of the skeletal system needing structural support. It is intended to be used in bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary process of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a five point linear scale to score bone formation at 28 days.

The provided text describes a 510(k) premarket notification for the GRAFTON® DBM device. This submission process focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through a controlled clinical trial with acceptance criteria for device performance. Therefore, many of the requested categories for a study proving device acceptance criteria are not directly applicable or explicitly stated in this type of submission.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" as used in studies proving device performance (e.g., sensitivity, specificity, accuracy) is not explicitly detailed in a 510(k) summary for a demineralized bone matrix allograft. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance data" section in a 510(k) typically refers to evidence supporting the device's functional characteristics and safety compared to predicates, rather than quantifiable metrics against predefined targets.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (as inferable from the 510(k) summary)

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

   • Osteoinductivity: An "athymic rat assay" was used. The sample size for this assay is not specified in the provided text.
   • "Studies in animals and humans": The text mentions "The results of studies in animals and humans showed that GRAFTON® DBM performs as well as, if not better than, predicate devices and/or performs at least as well at load." However, no specific sample sizes or details of these studies are provided.
   • Data Provenance: The athymic rat assay is an animal model. No specific country of origin or whether the animal/human studies were retrospective or prospective is mentioned.

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

   • This information is not provided in the 510(k) summary. For the athymic rat assay, the scoring system ("five point linear bone formation histological scoring system") is referenced, but the experts involved in applying this scoring or their qualifications are not detailed.

3. Adjudication method for the test set:

   • This information is not provided.

4. 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 MRMC or AI-assisted study was performed. GRAFTON® DBM is a bone graft product, not an AI-powered diagnostic or assistive device.

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

   • Not applicable, as this is not an AI algorithm.

6. The type of ground truth used:

   • Osteoinductivity: Histological scoring (0-5 scale) of bone formation in an athymic rat model at 28 days. This is a surrogate biological measure.
   • Viral Inactivation: Validation of the proprietary production process to inactivate specific viruses. This involves laboratory testing methods (e.g., spiking studies).
   • Overall Performance: Comparison to "predicate devices and/or performs at least as well at load." The exact ground truth for these comparisons is not specified but would likely involve clinical outcomes or functional assessments used for the predicate devices.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission for a non-AI bone graft. The "proprietary production process" for DBM is mentioned as having been "validated to consistently produce DBM that is osteoinductive," implying a developmental and validation phase, but specific training set sizes are not relevant here.

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

   • Not applicable in the context of this 510(k) submission for a non-AI bone graft. The consistency and osteoinductivity of the product are "confirmed via ongoing testing... utilizing a validated athymic rat assay." The "validation" of the production process implies a ground truth was used to establish its effectiveness in achieving osteoinductivity, likely based on the histological scoring in the athymic rat model.

Ask a specific question about this device