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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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