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The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.

The Kugel Hernia Patch™ is a surgical mesh for reinforcement of a hernia defect.

This looks like a 510(k) summary for a surgical mesh device, the Kugel Hernia Patch™. The information provided in this document is not for a device that relies on algorithms, AI, or advanced diagnostic performance metrics for its primary function. Therefore, most of the questions you've asked regarding acceptance criteria, study methodologies, and expertise related to AI/algorithm performance are not applicable to this specific device submission.

The Kugel Hernia Patch™ is a physical surgical implant, and its regulatory clearance focuses on material safety, sterility, biocompatibility, and substantial equivalence to existing devices.

Here's an explanation of why your questions don't fit and what information is relevant from the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (as implied by the document):
     • Biocompatibility per ANSI/AAMI/ISO 11135-1994
     • Sterility validation per ANSI/AAMI/ISO 11135-1994
     • Sterility testing per industry accepted protocols
     • LAL testing per industry accepted test protocols
     • Packaging integrity process validation
     • NTSB shipping durability test
     • Substantial Equivalence (to Atrium Polypropylene Mesh) in intended use, material, and sterilization method.
   • Reported Device Performance: The document states that these tests have been or will be performed. It
     does not provide the results of these tests or specific performance metrics (e.g., tensile strength, pore size, inflammatory response levels). For a surgical mesh, performance would be related to its physical properties and biological interaction, not diagnostic accuracy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is not evaluated through clinical trials or data sets in the way AI/diagnostic devices are. Its evaluation relies on bench testing of materials and manufacturing processes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant involves material science, microbiology, and biocompatibility experts, but not in the context of setting "ground truth" for diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for reconciling differing interpretations in diagnostic studies, which is not relevant here.

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: Not applicable. This is not an imaging or diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a surgical mesh, "ground truth" relates to material specifications, sterility, and biocompatibility standards. For example, "ground truth" for sterility would be the absence of microbial growth as confirmed by laboratory methods.

8. The sample size for the training set: Not applicable. This device does not use a "training set" in the machine learning sense. Material and performance data are generated through physical testing.

9. How the ground truth for the training set was established: Not applicable.

In summary, the Kugel Hernia Patch™ is a conventional medical device, and the provided 510(k) summary focuses on demonstrating its safety and substantial equivalence to a predicate device through material characterization, sterility testing, and biocompatibility assessments, not through performance metrics typically associated with AI or diagnostic systems.

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