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510(k) Data Aggregation
(118 days)
K161859, K21311
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.
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(133 days)
MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the bony structure.
MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.
MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects.
MagnetOs Easypack Putty consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.
MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects.
MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.
This document does not describe a study involving an AI/ML device, therefore, a description of acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable. The provided text is a 510(k) summary for a medical device called "MagnetOs Easypack Putty," which is a resorbable calcium salt bone void filler. It details the device's characteristics, intended use, and demonstrates substantial equivalence to predicate devices through non-clinical testing and animal studies, not AI/ML performance.
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(115 days)
OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.
OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and
The provided text describes the regulatory clearance for the OsOpia Synthetic Bone Void Filler. It does not, however, describe the acceptance criteria of a device (e.g., an AI/ML algorithm or diagnostic tool) in the typical sense of performance metrics like sensitivity, specificity, or F1-score. Instead, it details the criteria and studies used to demonstrate substantial equivalence for a medical device (a bone grafting material) to existing legally marketed predicate devices, as required for a 510(k) submission to the FDA.
Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in the context of this traditional medical device submission, which is not for an AI/ML device.
However, I can extract the relevant information from the provided document regarding how the device (OsOpia Synthetic Bone Void Filler) met the criteria for substantial equivalence.
Here's a breakdown based on the document:
1. Table of "Acceptance Criteria" (for Substantial Equivalence) and Reported Device Performance
| Criterion Type | Description of Criterion (as implied by FDA 510(k) process for this device type) | Reported Device Performance (OsOpia) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance for biological evaluation of medical devices (including cytotoxicity, irritation/sensitization, systemic toxicity, genotoxicity, implantation, and hemocompatibility, as applicable). | Assessed using ISO 10993-5 (cytotoxicity), ISO 10993-6 (local effects after implantation), ISO 10993-9 (degradation of materials), ISO 10993-10 (irritation and skin sensitization), and ISO 10993-11 (systemic toxicity). Found to be biocompatible per ISO 10993-1. |
| Sterilization Validation | Sterility Assurance Level (SAL) of 10^-6 for devices sterilized by gamma irradiation. | Validated in accordance with ISO 11137-1 and ISO 11137-2 to a sterility assurance level of 10^-6. |
| Shelf Life | Demonstration of product and packaging stability over the claimed shelf life, commonly through accelerated and real-time aging studies. Parameters like physical integrity, and product characteristics (e.g., chemical composition, functional properties) should be maintained. | Assigned based on accelerated and real-time aging studies of both packaging and product. Packaging tested with burst (ASTM F1140), peel (ASTM F88), and gross leak (ASTM F2096) tests. Product stability assessed by monitoring color, XRD, SEM, and porosity. |
| Bioburden/Pyrogenicity | Adherence to specifications for microbial load (bioburden) and absence of pyrogenic substances (bacterial endotoxin). | Verification batches met specifications for bioburden and pyrogenicity. Bacterial endotoxin testing (LAL method, USP) showed the device meets FDA established endotoxin limits. |
| Material Characterization | Demonstration of equivalent chemical composition, physical properties, and performance characteristics to predicate/reference devices through standardized testing. This typically includes identification of components, structural analysis, and functional assessments relevant to the device's intended use. | Performed in accordance with ASTM F1088. Included: X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR) for chemical composition; inductively coupled plasma/mass spectroscopy (ICP/MS) for trace elemental analysis; dissolution for in vitro calcium release rate; and mercury intrusion porosimetry for porosity. Analytical characterization demonstrated equivalent chemical composition, physical properties, and performance to predicate/reference devices. |
| Animal Study Performance | Demonstration of suitable performance as a bone grafting material in a relevant animal model for the intended use, showing bone formation and integration. | Evaluated in a sheep model for intraoral maxillary sinus floor augmentation surgery. Results demonstrated suitable performance as a bone grafting material for maxillary sinus augmentation. |
| Clinical Performance | For bone grafting materials, this often involves demonstrating suitable clinical outcomes such as new bone formation, implant survival rates in procedures where the graft is used, and absence of serious adverse events, to show safety and effectiveness comparable to marketed devices, especially for the stated indications (extraction sockets, maxillary sinus augmentation). | Six clinical studies (all prospective, one randomized, others single-arm) involving 90 patients were used. No serious adverse events reported. Two studies (at 5-6 months post-implantation) showed equal or greater new bone formation than control via bone histology. Four studies evaluated implant placement survival, reporting a survival rate of ≥96%. Demonstrated performance for socket extraction and maxillary sinus augmentation. |
| Indications for Use | The intended use and indications for use should be substantially equivalent to a predicate device, or any differences should not raise new questions of safety or effectiveness. The range of use (e.g., granule size) should be within or narrower than that of the predicate. | Proposed indications (extraction sockets and maxillary sinus augmentation) are narrower than the primary predicate (which includes root resection, apicoectomy, cystectomy, and periodontal defects in addition to sockets and sinus augmentation), raising no new questions of safety/effectiveness. Granule size range (250-1000 µm) is within the predicate's range (200-2000 µm) and narrower, thus raising no new safety/effectiveness issues. |
| Composition | The device's composition (e.g., ratio of β-TCP to HA) should be substantially equivalent to or reasonably compared with predicates or reference devices, without raising new safety/effectiveness concerns. | OsOpia: β-TCP >90%, HA 90%, HA |
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