GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES by W.L. GORE & ASSOCIATES,INC

Biocompatible, expanded polytetrafluoroethylene (ePTFE) with antimicrobial preservative agents in a flat sheet configuration of various length and width dimensions. Macropores are placed in the device in order to optimize rapid tissue fixation.

AI/ML Overview

This is a 510(k) summary for a medical device (GORE-TEX® DualMesh PLUS Biomaterial with Holes), not an AI/ML powered device, therefore the requested information regarding AI/ML study design and performance metrics is not applicable. The provided text describes the device's characteristics and its substantial equivalence to predicate devices based on mechanical strength testing.

Here's the relevant information that is available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Characteristic	Reported Device Performance
Suture Pull-Out Force (kg/5 pins)
Low Rate (Mean)	7.7
Low Rate (Std Dev)	0.5
High Rate (Mean)	8.2
High Rate (Std Dev)	0.7
Tensile Force to Break (kg/0.5")
Mean	8.3
Std Dev	0.3

Note: The document states that "Mechanical strength values of the applicant device are substantially equivalent to the mechanical strength values of the predicate devices and are sufficient for its indicated uses." The actual acceptance criteria (e.g., minimum thresholds for these mechanical properties) are not explicitly stated as numerical values in this summary but are implied by the comparison to predicate devices.

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

The document does not explicitly state the sample size used for the bench testing (e.g., number of units tested for suture pull-out or tensile force). The data provenance is "bench testing," meaning in-vitro laboratory testing, not clinical data from countries or retrospective/prospective studies.

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

Not applicable. This is a medical device composed of materials, not an AI/ML diagnostic or prognostic tool requiring expert interpretation of data for ground truth. The "ground truth" for mechanical properties is established by standardized physical testing methodologies.

4. Adjudication Method

Not applicable. This is not a study involving expert review or interpretation of data.

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

Not applicable. This is not an AI/ML powered device.

6. Standalone Performance Study

Not applicable. This is not an AI/ML powered device. The "standalone performance" is assessed through the mechanical bench testing reported.

7. Type of Ground Truth Used

The ground truth for the device's performance is established by physical measurement results from bench testing according to established engineering and material science protocols. Specifically, the "Tensile Force to Break" and "Suture Pull-Out Force" are objectively measurable properties.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device which requires a training set.

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

Not applicable. This is not an AI/ML powered device.

Summary

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VI. Premarket Notification 510(k) Summary

A. Submitted By: W.L. Gore & Associates, Inc. P.O. Box 900 Flagstaff, AZ 86002-0900

Contact : R. Larry Pratt Regulatory Affairs

Phone: 520-779-2771 520-779-3480 Fax:

B. Device Name: GORE-TEX® DualMesh PLUS Biomaterial with Holes
C. Applicant Device Description:

D. Indications For Use:
An implantable surgical mesh prosthesis indicated for the reconstruction of hernias and soft tissue deficiencies.
E. Predicate Devices:
Gore's surgical mesh products, GORE-TEX® DualMesh PLUS Biomaterial and GORE-TEX® DualMesh Biomaterial with Holes, are cited as predicate devices which have been found to be substantially equivalent through the premarket notification process.
F . Technological Characteristics:
The applicant device integrates the clinically successful attributes of GORE-TEX® DualMesh PLUS Biomaterial and GORE-TEX® DualMesh Biomaterial with Holes into a single device through the manufacture of macropores into GORE-TEX® DualMesh PLUS Biomaterial.

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The applicant device is manufactured using the same inert, biocompatible ePTFE material as the predicate devices. The antimicrobial preservative agents loaded into the applicant device are the same, and are loaded in the same amounts, as for the previously cleared GORE-TEX® DualMesh PLUS Biomaterial. The macropores manufactured into the applicant device have the same dimensions and are created using the same process as the macropores in the previously cleared GORE-TEX® DualMesh Biomaterial with Holes.

Mechanical strength values of the applicant device are substantially equivalent to the mechanical strength values of the predicate devices and are sufficient for its indicated uses .

	Applicant Device
Suture Pull-Out Force(kg/5 pins)	Mean	Std Dev
Low Rate	7.7	0.5
High Rate	8.2	0.7
Tensile Force to Break(kg/0.5")	8.3	0.3

G. Safety and Effectiveness Conclusions:

The applicant device is indicated for use in clinical applications which have previously been cleared for the predicate devices.

The applicant device is manufactured of the same inert, biocompatible expanded PTFE and the same antimicrobial preservative agents as the previously cleared GORE-TEX® DualMesh PLUS Biomaterial.

Macropores are created in the applicant device utilizing the same manufacturing process and technology as used for creating macropores in the previously cleared GORE-TEX® DualMesh Biomaterial with Holes.

The packaging materials and process used for the applicant device do not differ from those used for the predicate devices. The applicant device is sterilized using the same sterilization methods and utilizes the same poststerilization release criteria as the predicate devices.

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The applicant device has been shown via bench testing to have mechanical strength values substantially equivalent to the mechanical strength values of the predicate devices.

Combining clinical features from each of the previously cleared predicate devices into GORE-TEX® DualMesh PLUS Biomaterial with Holes does not compromise the safety or effectiveness of the applicant device. The manufacturing of macropores into the predicate GORE-TEX® DualMesh PLUS Biomaterial does not raise new types of safety or effectiveness questions. The descriptive and mechanical strength information contained within this Premarket Notification document are precise enough to demonstrate the substantial equivalency of GORE-TEX® DualMesh PLUS Biomaterial with Holes.

GORE-TEX and DualMesh are trademarks of W.L. Gore & Associates.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.