(118 days)
MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.
MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler, intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine, In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. The product is biocompatible.
MaqnetQs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and ß-tricalcium phosphate ceramic granules. The collagen is produced from highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The ceramic portion of MagnetOs Flex Matrix consists of β-tricalcium phosphate and hydroxyapatite.
MagnetOs Granules has a porous trabecular structure that resembles the structure and interconnected porosity of human cancellous bone. The surface of MagnetOs Granules is covered with needle-shaped features that are submicron in size.
The collagen matrix has a fibrillar porous structure which allows for the exposure of MagnetOs Granules' surface structure without interfering with its mode of action. While the collagen sponge matrix is readly resorbed in the first 6 weeks after implantation, MagnetOs Granules guides the three-dimensional regeneration of bone in the defect into which it is implanted. New bone will be deposited on the surface of the graft when it is placed next to viable host bone. The graft will be resorbed and replaced by bone during the natural process of bone remodelling.
MagnetOs Flex Matrix is a ready-to-use product. Upon hydration, the material is moldable and allows users to shape MagnetOs Flex Matrix to conform to the contours of bony defects. MagnetOs Flex Matrix is gamma-sterilized, sterile packaged and ready for single patient use only.
The K213959 510(k) submission for MagnetOs Flex Matrix describes a resorbable calcium salt bone void filler. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and animal studies.
Here's the breakdown of the acceptance criteria and study details based on the provided text, with specific answers to your numbered points:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria in a pass/fail format for specific performance metrics. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices in the following areas:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Summary) |
|---|---|
| Physicochemical and Crystallographic Characteristics | Bench-top testing confirmed that the MagnetOs Granules component in MagnetOs Flex Matrix is identical to the standalone MagnetOs Granules device. SEM and XRD confirmed the collagen matrix does not alter MagnetOs Granules specifications, ensuring its mode of action is not compromised. |
| Biocompatibility | Demonstrated through ISO 10993 testing and the long history of clinical use of collagen and calcium phosphate materials. Bacterial endotoxin testing (LAL method) showed the device meets established endotoxin limits. |
| Performance in Posterolateral Spine Fusion (as autograft extender) | Animal studies in a rabbit posterolateral spine fusion model demonstrated substantial equivalence in performance of MagnetOs Flex Matrix to the primary predicate device, MASTERGRAFT® Strip, as an autograft extender (1:1 volume ratio). Comparison with prior studies of MagnetOs Granules also confirmed substantial equivalence in performance. Evaluation endpoints included manual palpation, range of motion, radiography, micro-CT, undecalcified histology, and histomorphometric analysis. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The text mentions "animals" were evaluated in the rabbit posterolateral spine fusion model but does not specify the exact number of animals used in the study for MagnetOs Flex Matrix. It states "Animals were evaluated after implantation...".
- Data Provenance: The animal study was conducted using a rabbit posterolateral spine fusion model. The country of origin for the study is not specified in the document, but it's an animal study for pre-clinical performance testing. It is inherently prospective in its design as it involves implanting the device and then evaluating outcomes over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of human experts to establish ground truth in the context of the animal study. The evaluation endpoints were objective measures such as:
- Manual palpation
- Range of motion flexibility testing
- Plain and high-resolution radiography
- Microcomputed tomography (micro-CT) imaging
- Undecalcified histologic evaluation
- Histomorphometric analysis
The grading according to ISO 10993-6 (Annex E) for decalcified paraffin histology sections would typically be performed by trained histologists/pathologists, but the number and specific qualifications of such individuals are not detailed.
4. Adjudication method for the test set
The document does not describe an adjudication method (like 2+1 or 3+1) for the test set. Given that the ground truth was established through objective measurements and standard histological grading, an adjudication process involving multiple human readers for a "ground truth" establishment in a subjective interpretation sense is not indicated.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (bone void filler), not an AI-based diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The MagnetOs Flex Matrix is a physical medical device (bone void filler), not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the animal study (performance test set) was established through a combination of:
- Objective physiological assessments: Manual palpation, range of motion flexibility.
- Imaging data: Plain and high-resolution radiography, micro-CT.
- Histological and histomorphometric analysis: Microscopic evaluation of tissue samples, including grading according to ISO 10993-6 (Annex E).
- Comparison to controls: Autograft (positive control) and primary predicate device (MASTERGRAFT® Strip).
This can be categorized as a combination of animal model outcomes data and expert histological/imaging interpretation (though the number of experts is not specified).
8. The sample size for the training set
This question is not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of demonstrating substantial equivalence for a bone void filler through animal studies and bench testing.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.