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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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For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Biocompatible, expanded polytetrafluoroethylene (ePTFE) with a removable, tinted silicone component (DualMesh® EMERGE Biomaterial). Biocompatible, ePTFE loaded with antimicrobial preservative agents chlorhexidine diacetate and silver carbonate with a removable, tinted silicone component (DualMesh® EMERGE PLUS Biomaterial). Both devices have one open microstructure surface and one closed microstructure surface. The open microstructure surface is textured with a "ridges and valleys" pattern to aid in surface identification and proper surface orientation.

The provided text is a 510(k) Premarket Notification summary for the DualMesh® EMERGE Biomaterial and DualMesh® EMERGE PLUS Biomaterial. This submission describes a modification to an existing, currently marketed device and claims substantial equivalence to a predicate device.

For such a submission, the "acceptance criteria" and "device performance" are typically framed in terms of demonstrating that the modified device performs equivalently to the predicate device and that the modification does not raise new questions of safety or effectiveness. The studies performed are primarily designed to establish this equivalence, not to establish novel performance metrics against pre-defined clinical acceptance criteria like those seen for entirely new devices or AI software.

Therefore, the table below reflects the equivalence claims as the "acceptance criteria" and the "reported device performance" as confirmation of that equivalence through various tests.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for the bench tests, in-vitro antimicrobial activity tests, or in-vivo animal tests. It only states that these tests were performed and their results. The data provenance is not explicitly mentioned (e.g., country of origin), but it can be inferred that these studies were conducted to support a US FDA 510(k) submission. These studies would be considered prospective in nature, as they were conducted specifically for this submission to evaluate the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this submission. "Ground truth" in the context of expert consensus, as typically discussed for AI devices in diagnostics, is not relevant here. The studies involve laboratory measurements (mechanical properties, antimicrobial activity) and animal histological assessments, where "ground truth" is derived from established scientific methods and benchmarked against the predicate device. The experts involved would be those conducting these specialized tests (e.g., mechanical engineers, microbiologists, veterinary pathologists), but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. The bench and animal studies described here do not involve such a process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. An MRMC comparative effectiveness study is not applicable and was not done for this device. MRMC studies are typically used for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. This submission concerns a surgical mesh biomaterial, a physical implant.

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

This information is not applicable and was not done. This device is a biomaterial, not an algorithm or AI software for which standalone performance would be assessed.

7. The type of ground truth used

The "ground truth" for the various tests can be categorized as:

• Bench Test Data: Derived from standardized testing protocols and measurements of physical and material properties, often compared directly to specifications or predicate device values.
• In-vitro Antimicrobial Activity: Established through laboratory microbiological assays demonstrating inhibition of bacterial growth.
• In-vivo Animal Test Data: Established through histological examination of animal tissues, assessed by veterinary pathologists, and compared to the tissue response observed with the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. The concept of a "training set" is relevant to machine learning and AI, which are not involved in the development or evaluation of this biomaterial device.

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

This information is not applicable. As no "training set" in the AI/ML sense was used, no ground truth needed to be established for it.

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