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510(k) Data Aggregation
(59 days)
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
MAGNIFUSE® Bone Graft is intended for use as a bone graft substitute and bone void filler 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 Bone Graft is resorbed/ remodeled and is replaced by host bone during the healing process.
MAGNIFUSE® Bone Graft is comprised of human demineralized cortical bone fibers mixed with non-demineralized cortical bone fibers sealed in an absorbable PGA mesh pouch to form the final product.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAGNIFUSE® Bone Graft device:
Important Note: The provided document is a 510(k) Summary for a medical device and a clearance letter from the FDA. 510(k) clearances typically establish "substantial equivalence" to a predicate device rather than setting explicit, quantifiable "acceptance criteria" and proving performance against them in the same way a de novo or PMA application might. Therefore, the "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission, explicit numerical acceptance criteria are not stated in the document. Instead, the "acceptance criteria" are effectively demonstrating comparability or equivalence to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar material composition to predicate device | The subject MAGNIFUSE® Bone Graft has similar material composition to the predicate, both consisting of human cortical bone allograft tissue in a PGA mesh pouch. The allograft bone component in both consists of DBM fibers (osteoinductive) and a cortical bone allograft component (osteoconductive). |
| Similar Indications for Use statement to predicate device | The Indications for Use for the subject device are identical to the predicate: "for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure." |
| Identical operating principles to predicate device | Explicitly stated: "identical operating principles" |
| Identical finished product specifications to predicate device | Explicitly stated: "identical finished product specifications" |
| Equivalent performance in an animal model (remodeling and fusion rates) compared to predicate device | In vivo studies in animals showed "remodeling and fusion rates comparable to each other [subject and predicate] and to autograft bone." |
| Comparable osteoinductivity scores to predicate device | Osteoinductivity studies in an athymic rat model showed "comparable osteoinductivity scores for the subject and predicate MAGNIFUSE® Bone Grafts." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document mentions "in vivo studies of both subject and predicate MAGNIFUSE® Bone Graft implants in animals" and "Osteoinductivity studies in an athymic rat model." However, the specific number of animals/samples used in these studies is not provided in the summary.
- Data Provenance: The studies were preclinical/animal studies. The country of origin for the data is not specified, but it's implied to be part of the manufacturer's (Medtronic Sofamor Danek USA, Inc.) research given their location. The studies are prospective in nature, as they involve testing the device in animals to assess its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies are animal models and do not involve human expert interpretation of data in the sense of radiological or pathological diagnosis for establishing ground truth. The "ground truth" would be the direct biological outcomes (remodeling, fusion, osteoinductivity scores) observed in the animal models, rather than expert consensus on a human dataset.
4. Adjudication Method for the Test Set
This is not applicable as the studies are animal models evaluating biological endpoints, not human data requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the impact of an AI algorithm on human reader performance, which is not relevant for this bone graft device submission.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone algorithm performance study was not done. This device is a bone graft, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used in the performance studies was biological outcomes from animal models:
- In vivo studies: Remodeling and fusion rates in animals.
- Osteoinductivity studies: Osteoinductivity scores in an athymic rat model.
8. Sample Size for the Training Set
This is not applicable. The MAGNIFUSE® Bone Graft is a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The performance studies mentioned are for biological evaluation of the device itself.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for a physical bone graft device.
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