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TephaFLEX® Composite Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: repair of colon and rectal prolapse (excluding rectocele) using an abdominal approach, sacral colposuspension and reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapsed). The film side of the device may help minimize the potential for tissue attachment to the mesh in case of direct contact with the viscera.

The TephaFLEX composite mesh is comprised of a layer of TephaFLEX knitted mesh with a layer of TephaFLEX film on one of its sides. The mesh is prepared from size 5-0 monofilament P4HB fiber and the film is a solid sheet of P4HB material. The knitted mesh side of the construct allows for tissue in growth while the film side provides a layer that physically separates the knitted mesh from underlying tissue and organ surfaces during the wound healing period to minimize tissue attachment to the mesh in case of direct contact with the viscera.

This document describes the safety and effectiveness of the TephaFLEX Composite Mesh through a 510(k) premarket notification. The study primarily relies on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for a novel AI or diagnostic device. As such, many of the requested categories for AI/diagnostic studies are not applicable.

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Acceptance Criteria and Device Performance

The device, TephaFLEX Composite Mesh, is seeking substantial equivalence to existing predicate devices (TephaFLEX Surgical Film and TephaFLEX Surgical Mesh). The acceptance criteria are implicitly based on demonstrating comparable mechanical properties and in vivo biological responses to these predicate devices. The "reported device performance" is the conclusion that the device meets substantial equivalence.

Study Conclusion: "The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices."

Additional Requested Information:

Since this is a submission for a surgical mesh, not a software-driven AI or diagnostic device, many of the requested categories pertaining to AI/ML device studies are not directly applicable.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an algorithmic test set. The testing involved in vitro mechanical tests and in vivo animal studies.
   • Data Provenance: The in vivo testing was an "implantation study with histological assessments out to 78 weeks." This implies prospective animal studies conducted to gather safety and performance data. The country of origin for these studies is not specified but would typically be conducted in the country where the manufacturer is located or specialized contract research organizations.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of device performance testing for a surgical mesh. "Ground truth" here refers to established scientific methods for mechanical testing and histopathological assessment, which are typically performed by trained technicians and pathologists, not "experts" establishing truth for an AI algorithm.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are typically for subjective assessments in diagnostic studies. The mechanical and histological assessments are objective measurements or standard interpretations.

4. 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:

   • Not applicable. This is not an AI-assisted diagnostic or interpretation device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For mechanical properties: Standardized mechanical testing procedures (e.g., burst strength, tensile strength, tear resistance) with specific metrics being the "ground truth."
   • For in vivo response: Histological assessments (pathology) from animal implantation studies out to 78 weeks were used to evaluate tissue ingrowth, inflammation, degradation, and other biological responses.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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