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The UGYTEX Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

The UGYTEX Mesh is a surgical mesh used during open or laparoscopic procedures. The UGYTEX Mesh is made from polypropylene and a collagen based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the mesh but serves to temporary separate the mesh from adjacent organs to minimize visceral attachment to the mesh, which may occur during the healing process. The UGYTEX Mesh is offered in several sizes and shapes to accommodate the type and approach of the operation.

The UGYTEX® Mesh 510(k) summary does not contain the detailed information necessary to complete all sections of your request comprehensively. Specifically, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study protocol for a novel device performance evaluation against specific acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The provided 510(k) summary describes Performance Testing as the study undertaken to demonstrate the UGYTEX Mesh meets the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the performance testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Based on the nature of a 510(k) submission for a physical device, this testing would typically be prospective laboratory and possibly animal testing rather than human clinical trial data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in this 510(k) summary. The performance testing described (biocompatibility, density, thickness, etc.) are objective physical and chemical tests, not evaluations requiring expert review of subjective data.

4. Adjudication Method

This information is not applicable and therefore not provided. Given the nature of the physical and chemical tests, an adjudication method for ground truth establishment is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support AI devices, not with a surgical mesh. The submission focuses on the material's physical and biological properties.

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

Not Applicable. The UGYTEX® Mesh is a physical surgical implant, not an algorithm or AI device. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing cited was based on objective measurements and laboratory evaluations of the physical and material properties of the UGYTEX Mesh, compared against accepted standards for surgical meshes and/or the properties of the predicate devices. For biocompatibility, it would be based on established toxicology and biological evaluation standards.

8. The Sample Size for the Training Set

This information is not applicable. The UGYTEX® Mesh is a physical product, not a software algorithm that requires a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as point 8.

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