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MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. 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. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in intervertebral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.

MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler for the repair of bony defects. The product is biocompatible.

MagnetOs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and Btricalcium phosphate ceramic (92.5-95.5 wt% MagnetOs Granules and 4.5-7.5 wt% collagen). The ceramic portion of MagnetOs Flex Matrix consists of 75-65% B-Tri-Calcium Phosphate and 25-35% Hydroxyapatite. The collagen is produced of highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The components are mixed in a slurry and lyophilized, which results in a highly porous sponge matrix that provides cohesion between the MagnetOs Granules without inhibiting the granule surface structure.

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 supplied as a ready-to-use strip, it is sterile packaged and gammasterilized for single patient use only.

The provided document is a 510(k) summary for a medical device called MagnetOs Flex Matrix. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving objective performance against predefined acceptance criteria for AI/ML devices. Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 about acceptance criteria, specific study details, and training set information typically associated with AI/ML device evaluations.

However, I can extract information related to performance testing that was conducted to support the substantial equivalence claim.

Performance Testing Summary (as described in the document):

The performance testing primarily aimed to demonstrate substantial equivalence to a predicate device, not necessarily to meet specific, quantifiable acceptance criteria in the manner an AI/ML device would.

• Animal Testing: Performed in a rabbit posterolateral fusion model to demonstrate substantial equivalence to a legally marketed predicate device.
• In-vitro Studies: Showed that MagnetOs Flex Matrix induced the growth of a bone-like apatite layer on the surface of the MagnetOs Granules component following exposure to simulated body fluid.
• Other Non-Clinical Testing: In support of a prior clearance (K213959), non-clinical testing data were submitted according to FDA guidance documents. These data covered:
  • Physical properties
  • Sterilization
  • Product shelf life
  • Biocompatibility

Missing Information (as per your request):

The document does not provide any of the following information, as it is not a study designed to demonstrate performance against specific acceptance criteria for an AI/ML device:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or effect size of human reader improvement with AI.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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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:

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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