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GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.

The GORE-TEX DualMesh EMERGE PLUS Biomaterial consists of an ePTFE mesh coated with silver carbonate and chlorhexidine diacetate and a silicone component attached to the closed microstructure side of the ePTFE component with a silicone adhesive. The silicone component is designed to provide a stiffening effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component.

The provided document, K032168, for the GORE-TEX DualMesh EMERGE PLUS Biomaterial, is a Special 510(k) Premarket Notification. This type of submission relies on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting novel clinical performance data against specific acceptance criteria for a new device.

Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the way a new, high-risk device might. Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify a sample size for a "test set" in the context of a clinical study or performance evaluation with human subjects.
• The studies mentioned are "device integrity testing," which typically refers to bench testing rather than human subject trials.
• Data Provenance: Not applicable in the context of human subject testing. The "data" refers to internal W.L. Gore & Associates, Inc. testing.

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

• Not applicable. This was not a study involving expert review or ground truth establishment for a clinical assessment. The "ground truth" for substantial equivalence is based on comparison to legally marketed predicate devices and internal engineering and material testing.

4. Adjudication Method:

• Not applicable. There was no clinical study involving adjudication of outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This was not an MRMC study. The device is a surgical mesh, not an imaging or diagnostic device that would typically involve human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• No. This is a physical biomaterial, not an algorithm or AI system.

7. Type of Ground Truth Used:

• The "ground truth" in the context of this 510(k) submission is the data from device integrity testing (bench testing) and the established safety and effectiveness profile of the predicate devices (GORE-TEX DualMesh EMERGE, EMERGE PLUS, and DualMesh PLUS Biomaterials). The focus is on demonstrating that the new device shares the same fundamental scientific technology and intended use as these legally marketed products and that any modifications do not raise new questions of safety or effectiveness.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm or system that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this type of device.

Summary of the Study that Proves Acceptance:

The "study" that proves the device meets (implied) acceptance criteria is described as "device integrity testing" performed by W.L. Gore & Associates, Inc. This testing aimed to demonstrate that the GORE-TEX DualMesh EMERGE PLUS Biomaterial is equivalent to its predicate devices. The document states: "All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements."

This implies that internal specifications and benchmarks, likely derived from the predicate devices' performance characteristics, served as the "acceptance criteria" for these integrity tests. The specific details of these tests (e.g., tensile strength, burst strength, biocompatibility, drug elution rates for the coatings) and their quantitative results are not included in this summary document, as is typical for 510(k) summaries which focus on demonstrating substantial equivalence rather than providing detailed study reports. The FDA's clearance (K032168) confirms that, based on the submitted data, including these integrity tests, the device was deemed substantially equivalent.

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