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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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MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) 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. MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

MAGNIFUSE® II Bone Graft is assembled by the clinician at the time of the procedure using the supplied human bone allograft tissue matrix mixed 1:1 with autograft tissue. The mixture is packed into a polyglycolic acid (PGA) resorbable mesh bag with the supplied injection molded plastic spatula, funnel, and plunger. This product enables clinicians to generate a construct having a particular physical form and handling property. No additional carrier is added to the allograft material. This MAGNIFUSE® II Bone Graft product was prepared from human bone tissue recovered from a cadaveric donor using aseptic surgical techniques and microbiologically tested during recovery. As a biological material, some variations in the product should be expected in both handling and appearance. The final product in packaged form was tested for sterility according to the procedures in the current U.S. Pharmacopoeia USP standard .

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This submission is for a bone graft substitute, and its acceptance hinges on demonstrating substantial equivalence to a predicate device (GRAFTON® II eDBM) through non-clinical testing. The "acceptance criteria" here are implicitly tied to showing comparable performance to the predicate and established safety profiles. The study primarily focuses on fusion rates and host tolerance in a validated animal model.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a bone graft substitute demonstrating substantial equivalence, the "acceptance criteria" are not explicitly quantitative thresholds like you might find for an AI diagnostic device (e.g., AUC > 0.9). Instead, they are performance characteristics expected to be comparable to the predicate device to establish substantial equivalence.

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

• Sample Size for Non-Clinical Study: The document states "A Rabbit posterlateral lumbar fusion study was conducted..." but does not specify the exact number of rabbits used in the study. It refers to "All animals tolerated the graft material well," implying a group of subjects.
• Data Provenance: The data comes from a prospective animal study (rabbit posterolateral lumbar fusion study). The country of origin is not explicitly stated, but Medtronic Sofamor Danek USA is based in Memphis, Tennessee, suggesting a U.S.-based study.

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

• The non-clinical study involves animal models (rabbits and athymic rats) where "ground truth" would likely be established through histological analysis, radiography evaluation, and macroscopic observation.
• The document does not specify the number of experts or their qualifications (e.g., veterinary pathologists, orthopedic surgeons evaluating radiographs/histology) who assessed the outcomes of the rabbit study or the athymic rat assay. It refers to "scoring bone formation" in the rat assay, implying expert evaluation.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for assessing the outcomes of the animal studies. Assessments like "comparable fusion rates" and "tolerated the graft material well" suggest evaluation by researchers, but the specific process for resolving discrepancies is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study is designed to evaluate human reader performance with and without AI assistance, typically in diagnostic imaging. This submission is for a bone graft substitute and relies on non-clinical (animal) studies to demonstrate substantial equivalence, not human reader performance.

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

• Not applicable. This device is a bone graft substitute, not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The performance evaluated is the biological performance of the graft material itself.

7. The Type of Ground Truth Used

• Animal Model Outcomes (Histology, Radiography, Macroscopic Observation):
  • For the rabbit posterolateral lumbar fusion study, the ground truth for "fusion rates" would likely be established by a combination of radiographic assessment and histological evaluation of the spinal segments. "Tolerance" would be based on clinical observation and potentially gross pathology.
  • For the athymic rat assay, the ground truth for "osteoinductivity" is established by "scoring bone formation at 28 days post implantation" using a "five-point linear scale (0, 1, 2, 3, 4)." This is a histological assessment.

8. The Sample Size for the Training Set

• The concept of a "training set" is relevant to machine learning algorithms. This submission is for a biological device (bone graft). Therefore, there is no "training set" in the context of AI or algorithms. The "training" for such a device is implicitly in the development and refinement of its manufacturing processes and material composition.

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

• As there is no "training set" in the AI/algorithm sense, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through extensive material science, biological compatibility testing, and historical performance of similar predicate devices, which are all part of the product development and regulatory submission process.

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Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the claim of "effective bone formation through fusion" and "equivalence to autograft." The device performance is the demonstration that it met these criteria.

Study Information

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

   • Test Set Sample Size: Not explicitly stated as a number of rabbits, but the study was conducted in a "posterolateral rabbit spine model."
   • Data Provenance: Animal study (rabbit model), likely prospective (an experimental study designed to test the device). Country of origin is not specified.

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

   • Not specified. The assessment involved "Radiographic, histological and biomechanical evidence," suggesting evaluation by relevant experts in these fields (e.g., veterinary radiologists, histopathologists, biomechanical engineers), but their number or specific qualifications are not provided.

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

   • Not specified.

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. This was not an MRMC study comparing human readers or AI assistance. It was an animal study evaluating direct device performance.

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

   • N/A. This device is a bone void filler, not an algorithm.

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

   • The ground truth was established through radiographic, histological, and biomechanical evidence from the animal model. This combines imaging findings, tissue analysis (pathology), and functional/mechanical testing to assess bone formation and fusion.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device, so there is no "training set."

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

   • N/A.

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