GORE-TEX® DualMesh® Biomaterial is indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Device Description

Biocompatible, expanded polytetrafluoroethylene (ePTFE) with one open microstructure surface and one closed microstructure surface. The open microstructure surface is texturized with a "corduroy" pattern to aid in surface identification and proper surface orientation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Strength	Substantially equivalent to the predicate device.	"Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device."
Material Characterization	Substantially equivalent to the predicate device.	"Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device."
Safety	Functions safely as a surgical mesh.	"The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh." "The modification described in this Premarket Notification does not raise questions of safety or effectiveness that have not been previously addressed."
Effectiveness	Functions effectively as a surgical mesh. Equivalent performance to the predicate device.	"The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh." "In-vivo animal testing demonstrates the applicant device performs equivalent to the predicate device."
Biocompatibility	Maintained from the predicate device.	"Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Materials	Maintained from the predicate device.	"Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Design	Maintained from the predicate device (other than the surface texturing pattern).	"Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device has not changed from those for the predicate device." "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Packaging	Maintained from the predicate device.	"Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Sterilization Process	Maintained from the predicate device.	"Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device." "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Intended Use	Unchanged from the predicate device.	"The modified texturing pattern does not change the device's intended use or indications." "The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Possible Adverse Reactions	Not different from the predicate device.	"The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility..."
Overall Equivalence	Substantially equivalent to the predicate device regarding intended use, possible adverse reactions, materials, design, biocompatibility, packaging, sterilization process, mechanical strength, and material characterization values. Performs equivalent to the predicate device.	"The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility, packaging, sterilization process, mechanical strength and material characterization values." "In-vivo animal testing demonstrates the applicant device performs equivalent to the predicate device."

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

Test Set Sample Size: Not explicitly stated. The document mentions "in-vivo animal testing" but does not specify the number of animals or trials.
Data Provenance: "in-vivo animal testing" suggests a prospective animal study. The country of origin is not specified.

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)

Not applicable. The study is an animal (in-vivo) and bench testing study, not a human reader study requiring expert ground truth for interpretation. The ground truth would be based on histological analysis and mechanical measurements.

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

Not applicable in the context of an animal and bench testing study as 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh, not an AI or imaging diagnostic tool.

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

Not applicable. This is a medical device (surgical mesh), not an algorithm or AI. The performance is assessed through bench tests and animal studies.

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

Bench Testing: Mechanical measurement data and material characterization data.
Animal Testing: Histological response.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning model that requires a training set. The "training" in this context refers to the manufacturing process for the device itself.

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

Not applicable. As this isn't an AI model, there isn't a "training set ground truth" in the machine learning sense. The device's design, materials, and manufacturing processes are established based on engineering principles and existing predicate device validation, aiming to meet specific performance standards.

Summary

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JUL 29 1999

K992189

Attachment IV Special 510 (k) Premarket Notification GORE-TEX® DualMesh® Biomaterial

Premarket Notification 510(k) Summary

W.L. Gore and Associates, Inc. A. Submitter 3750 W. Kiltie Lane P.O. Box 900 Flagstaff, AZ 86002-0900

520-779-2771

R. Larry Pratt Contact :

Date Submitted: June 28, 1999

B. Applicant Device

Trade Name: GORE-TEX® DualMesh® Biomaterial.

Classification Name: Surgical Mesh.

C. Applicant Device Description

D. Applicant Device Indications For Use

GORE-TEX® DualMesh® Biomaterial is indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

E. Predicate Device
The previously cleared GORE-TEX® DualMesh® Biomaterial with a "hexagon" identification pattern is cited as the predicate device.

F. Technological Characteristics

This Premarket Notification submission is for a modification to an existing, currently marketed device. The modification is to change the texturing pattern on the tissue ingrowth surface of the predicate device.

The modified texturing pattern does not change the device's intended use or indications. Similarly, the materials, design, biocompatibility, packaging and sterilization process for the applicant device have not changed from those for the predicate device.

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Bench test data reveal the applicant device has mechanical strength and material characterization values which are substantially equivalent to the predicate device.

The histological response shown by in-vivo animal testing demonstrates that the applicant device functions both safely and effectively as a surgical mesh.

Design control and verification testing has been performed for this device modification.

G. Safety and Effectiveness Conclusions

This Premarket Notification concerns a modification to the surface identification pattern for use in proper surface orientation. The applicant device is substantially equivalent to the predicate device with regard to intended use, possible adverse reactions, materials, design, biocompatibility, packaging, sterilization process, mechanical strength and material characterization values. In-vivo animal testing demonstrates the applicant device performs equivalent to the predicate device.

The modification described in this Premarket Notification does not raise questions of safety or effectiveness that have not been previously addressed. Both the applicant device and the predicate device perform their equivalent clinical functions by incorporating biocompatible materials to permanently or transiently bridge or support a tissue defect.

The applicant device is substantially equivalent to the previously cleared predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Mr. R. Larry Pratt Regulatory Affairs W. L. Gore & Associates, Inc. Medical Products Division 3450 West Kiltie Lane Flagstaff. Arizona 86002

Re: K992189

Trade Name: GORE-TEX DualMesh Biomaterial Regulatory Class: II Product Code: FTL Dated: June 28, 1999 Received: June 29, 1999

Dear Mr. Pratt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be lound in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. R. Larry Pratt

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 10(k) Number (if known):

Device Name: GORE-TEX DualMesh Biomaterial

Indications For Use:

GORE-TEX DualMesh Biomaterial is indicated for the reconstruction GORE-IEX Dualmest Bromaocirar is Includes and for the temporary bridging of fascial defects.

92189

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992183

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)
		(Optional Format 1-2-96)

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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.