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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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