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Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

The modified XL Composix Kugel Mesh is a self-expanding, two-layered mesh with two extruded monofilament PET polymer "rings". The mesh is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The mesh is knitted to form a strong, porous, support material. The knit structure of the polypropylene mesh is identical to that of the predicate Composix Kugel Mesh product and allows for repair of the defect. The monofilament PET polymer "rings" add stability to the device enabling greater simplicity and assurance in the proper placement of the patch.

The provided text describes a 510(k) premarket notification for a medical device, the "Modified XL Composix Kugel Mesh." It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed study proving the new device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document because they are generally not required for a 510(k) submission that relies on equivalence to a predicate device.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

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

   Acceptance Criteria	Reported Device Performance
   N/A	N/A

   Explanation: The document does not explicitly state acceptance criteria or provide a table of device performance against such criteria. The submission is based on demonstrating "substantial equivalence" to a predicate device, not on meeting predefined performance metrics through a clinical study.

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

   • Sample Size for Test Set: Not applicable. No test set for a clinical study is described.
   • Data Provenance: Not applicable. The "Performance Data" section mentions "Bench testing," which is typically laboratory-based and doesn't involve patient data from specific countries or study designs (retrospective/prospective).

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):

   • Number of Experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
   • Qualifications of Experts: Not applicable.

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

   • Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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:

   • MRMC Study: No. This document describes a medical mesh device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant or mentioned.
   • Effect Size: Not applicable.

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

   • Standalone Performance Study: Not applicable. This is a medical device (mesh), not a software algorithm.

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

   • Type of Ground Truth: Not applicable for a clinical study. For bench testing, the "ground truth" would be engineering specifications and validated measurement methods to assess the device's physical properties.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that would require training data.

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

   • Ground Truth Establishment for Training Set: Not applicable.

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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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