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The Exogenesis Hernia Mesh is indicated for the repar of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair.

The Exogenesis Hernia Mesh is intended for single patient one-time use only.

The Exogenesis Hernia Mesh is a sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The device is intended for the repair of hernias and other fascial deficiencies requiring the addition of reinforcing or bridging material to obtain the desired surgical result. The Exogenesis Hernia Mesh is composed of knitted filaments of extruded polypropylene, and knitted to provide elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The Exogenesis Hernia Mesh is treated with a proprietary technology to modify the surface of the mesh to increase surface area of the filaments on a microscopic level.

The provided text describes a medical device, the "Exogenesis Hernia Mesh," and its substantial equivalence to a predicate device, the "Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than reporting a study with specific acceptance criteria for performance measurements in the context of device performance metrics like sensitivity/specificity for algorithms.

Therefore, the information requested, which is typically relevant for AI/ML-based device studies, is largely not present in this document. The device in question is a surgical mesh, not a software algorithm, so many of the questions regarding AI/ML study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable.

However, I can extract the available information related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit acceptance criteria in a quantitative sense as might be seen for an algorithm (e.g., "sensitivity must be > X%"). Instead, it focuses on demonstrating comparability to the predicate device. The "acceptance criteria" are implied by the demonstration of "no significant differences" or "comparable" results, or exceeding a basic biological benchmark (like abdominal muscle strength).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Performance Testing," "Biocompatibility testing," and "animal testing," but does not specify sample sizes for these tests, nor the data provenance (country, retrospective/prospective). These are typically proprietary details submitted to the FDA separately.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a surgical mesh, not an AI/ML algorithm requiring expert interpretation for ground truth establishment.

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

This is not applicable for the same reason as above.

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

This is not applicable as the device is a surgical mesh, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a surgical mesh, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the mechanical and physical property testing, the "ground truth" would be the measured physical properties themselves (e.g., burst strength, tensile strength) obtained through standardized testing methods, and for biocompatibility, it would be the results of the specific biological tests. For the animal study, the "ground truth" would be the in vivo measurements and observations of burst strength and localized tissue interaction. These are not "expert consensus" or "pathology" in the diagnostic sense, but rather objective measurements from laboratory and animal models.

8. The sample size for the training set

This is not applicable as the device is a physical product (surgical mesh), not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The "study" presented here is a demonstration of Substantial Equivalence to a legally marketed predicate device (Ethicon, Inc. Prolene Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh – K180829) rather than meeting a set of independent performance criteria.

The demonstration of substantial equivalence involved:

• Comparison of Technological Characteristics: Showing the Exogenesis Hernia Mesh has the same intended use, similar material composition (polypropylene), similar construction (knitted filaments), and is also sterile and single-use, compared to the predicate.
• Performance Testing (Bench Testing):
  • Biocompatibility testing: Performed on the final version of the Exogenesis Hernia Mesh to support the material's equivalence even with the proprietary surface treatment.
  • Physical Characteristics Comparison: Compared the Exogenesis Hernia Mesh (both untreated and with proprietary processing) to the predicate device.
    • Results showed "no significant differences" between the untreated and processed Exogenesis mesh in physical/mechanical parameters, indicating the processing does not alter fundamental structure and function.
    • Results showed "no significant differences" between Exogenesis Hernia Mesh and predicate in mesh thickness and single-fiber thickness.
    • Exogenesis Hernia Mesh had "greater" pore size than the predicate.
    • "No differences" in tear resistance between Exogenesis and predicate.
    • Prolene (predicate) demonstrated "higher tensile, suture pull-out and burst strength" than Exogenesis, which is attributed to Prolene being a "stiffer mesh." However, the Exogenesis mesh was reported to be higher than another published mesh (Prolite Ultra) in tensile strength, and importantly, "all meshes reported higher burst strength than that of abdominal muscle," indicating adequate strength for the intended use.
• Animal Testing:
  • Assessed localized tissue interaction and mechanical properties (burst strength) of untreated vs. processed Exogenesis Hernia Mesh.
  • Results at Day 90 and Day 180 showed both versions of the Exogenesis Hernia Mesh were "comparable in burst strength," and "both were much greater in burst strength as compared to the native abdominal wall."

The conclusion drawn is that the biocompatibility testing, bench testing, and animal testing collectively "support substantial equivalence" to the predicate device, thus demonstrating the device meets the regulatory requirements for market clearance via the 510(k) pathway.

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