(118 days)
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.
The implant in the subject device kit for 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 accessories included in the kit that consist of disposable plastic instruments spatula, funnel, and plunger. The resorbable mesh bag provides containment of the allograft/autograft mixture to prevent migration of the grafting material. The allograft component is comprised of processed human cortical allograft bone particles consisting of demineralized bone matrix (DBM) in a fiber form and non-demineralized cortical fibers.
The provided document is a 510(k) Premarket Notification for MAGNIFUSE® II Bone Graft. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device itself against specific numerical targets.
The device is a resorbable calcium salt bone void filler that includes a human bone allograft tissue matrix. The purpose of this specific 510(k) application (K131673) is to modify the composition, ratio, and processing technique of the allograft component to improve donor utilization.
Therefore, the "acceptance criteria" discussed are largely tied to demonstrating that these modifications do not alter the substantial equivalence to the predicate devices in terms of safety and effectiveness.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the modified device's performance, as evaluated through non-clinical testing, is equivalent to that of the predicate device. Direct numerical performance targets for the final product are not explicitly stated as acceptance criteria in the document in the way one might see for a diagnostic device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Allograft Component: Equivalent composition, ratio, and processing method to predicate K123691. | "Identical" to K123691 (S.E. 01/31/2013) for Demineralized Bone Matrix (DBM) in fiber form, non-demineralized fibers, allograft ratio, and processing method of DBM fibers. |
| Bone Formation Capabilities: Equivalency in bone formation to predicate K123691. | Rabbit posterolateral lumbar spinal fusion study demonstrated "equivalency" to predicate MAGNIFUSE® Bone Graft device K123691 in manual palpation and radiographic results. |
| Osteoinductivity: Consistently produce demineralized bone matrix that is osteoinductive. | "Proprietary processing method that has been shown to consistently produce demineralized bone matrix that is osteoinductive in an athymic rat assay." Confirmed via ongoing testing utilizing a five-point linear scale (0, 1, 2, 3, 4) to score bone formation at 28 days post implantation. |
| Viral Inactivation: Validation of processing steps to inactivate target viruses. | Proprietary processing steps (demineralizing acid soaks, alcohol soaks, dehydration, supercritical CO2 for non-demineralized fibers) "have been shown and validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus." |
| Overall Equivalence: Identical Indications for Use, Fundamental Scientific Technology, Basic Design, Performance, Sterilization, Shelf-Life, Packaging, Use of Rigid Fixation, Safety and Effectiveness profile, PGA Mesh bag Closure Mechanism to predicate K122513. | All listed features are reported as "Identical" to K122513 (S.E. 03/06/2013). |
2. Sample Size Used for the Test Set and Data Provenance
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Rabbit Posterolateral Lumbar Spinal Fusion Study:
- Sample Size: Not explicitly stated how many rabbits were used.
- Data Provenance: Prospective, animal study (rabbit), conducted to evaluate the proposed allograft formulation change. Country of origin not specified, but the submission is from a US-based company, suggesting the study was likely conducted in the US or in a manner compliant with US regulations.
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Athymic Rat Assay for Osteoinductivity:
- Sample Size: Not explicitly stated for initial validation, but mentions "ongoing testing" of finished product. The reference Edwards et al; Clinical Orthopaedics, December 1998, Vol 357 typically would contain details about sample size for the original method validation.
- Data Provenance: Prospective, animal study (athymic rat). Country of origin not specified, but likely US-based due to the submitter's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of human experts establishing "ground truth" in the context of diagnostic interpretation for this bone graft device. The studies described are animal model studies evaluating biological response (bone formation) and viral inactivation, not human diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring adjudication of human interpretative results. The evaluation methods for the animal studies (manual palpation, radiography, athymic rat assay scores) are objective measurements.
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 device is a bone graft, not a diagnostic imaging AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone graft, not a diagnostic algorithm.
7. The Type of Ground Truth Used
- For Bone Formation: The "ground truth" for the rabbit posterolateral lumbar spinal fusion study would be the direct observation and measurement of bone formation in the animal model, likely assessed via histological analysis, micro-CT, and potentially biomechanical testing, in addition to manual palpation and radiography.
- For Osteoinductivity: The "ground truth" for the athymic rat assay is the observation and scoring (0-4 linear scale) of bone formation within the implanted material at 28 days post implantation, indicating its osteoinductive capacity.
- For Viral Inactivation: The "ground truth" is the quantitative reduction of infectious viral particles (as measured in validated lab assays) after exposure to the processing steps.
8. The Sample Size for the Training Set
Not applicable in the context of this biological device. There is no "training set" as understood for AI/machine learning models. The development of the device's formulation and processing methods would be analogous to a "training" phase, where various formulations and processes are tested to achieve desired properties. However, specific "sample sizes" for such development trials are not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" with established ground truth in the AI/ML sense. The "ground truth" for the development of the bone graft would involve iterative laboratory and animal testing to assess performance characteristics (e.g., cell viability, mechanical properties, in vitro osteoinductivity, in vivo bone formation) of various formulations. These development phases are not detailed in a 510(k) summary, which focuses on the final validation of the modified product.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.