GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.

Device Description

As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling softtissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.

AI/ML Overview

The provided text describes a medical device, the GORE® ENFORM Biomaterial, and its FDA 510(k) premarket notification. However, it does not include acceptance criteria, specific device performance data in a table format, or details about a study that proves the device meets specific acceptance criteria in the way typically found for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a traditional medical product (surgical mesh).

Here's an attempt to answer your questions based solely on the provided text, highlighting what is and isn't available:

Since this document describes a traditional medical device (surgical mesh), not an AI/ML powered device, most of the requested information (like sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not provided in this type of submission.

Therefore, the table of acceptance criteria and reported device performance from an AI/ML perspective cannot be created as the data is not present. The "performance criteria established for the indicated uses of the device" are mentioned as having been met, but the specific criteria and results are not detailed.

Here's what can be extracted based on your desired headings:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states: "Results demonstrated that both configurations of the GORE® ENFORM Biomaterial met the performance criteria established for the indicated uses of the device." However, the specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum stiffness, specific biological response thresholds) are not detailed in this document.
Reported Device Performance: Similarly, the specific quantitative performance results are not detailed. The document broadly states that the device "met the performance criteria" and "demonstrated substantial equivalence" to predicate devices.

2. Sample sized 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 specified. The document mentions "Bench study" and "Animal study" but does not provide sample sizes for these studies.
Data Provenance: Not specified. Animal studies are mentioned, but details on the species, number of animals, or study design (e.g., retrospective/prospective) are absent.

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 / Not Provided. For a surgical biomaterial, "ground truth" would typically be established through histological analysis, physical testing, and clinical observations in animal models. The experts involved in evaluating these results (e.g., pathologists, surgeons, material scientists) are not specified.

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

Not Applicable / Not Provided. This concept is more relevant to AI model evaluation where multiple human readers assess cases. For a traditional device, testing focuses on physical properties, biocompatibility, and physiological response, which are typically measured objectively or evaluated by specialists without a "reader adjudication" process.

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. Not Applicable. This device is a biomaterial, not an AI/ML product designed to assist human readers.

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

No. Not Applicable. This device is a biomaterial, not an algorithm.

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

For the Animal Study, the "ground truth" would implicitly be derived from observed physiological responses, tissue ingrowth, and visceral protection evaluations (likely through gross observation, histology/pathology, and potentially biomechanical assessments in the animals).
For Bench Testing, the "ground truth" would be the measured physical properties against established material specifications or predicate device performance.

8. The sample size for the training set

Not Applicable / Not Provided. This device is not an AI/ML product developed using training data.

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

Not Applicable / Not Provided. This device is not an AI/ML product.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 5, 2018

W.L. Gore & Associates, Inc. Barbara Smith Regulatory Associate 1505 N. Fourth Street Flagstaff, Arizona 86004

Re: K173333

Trade/Device Name: GORE ENFORM Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF, OXC, OWT, OWZ Dated: October 20, 2017 Received: October 23, 2017

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173333

Device Name GORE® ENFORM Biomaterial

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Submitter

W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Barbara L. Smith, RAC Phone: 410-506-8189 E-mail: blsmith@wlgore.com

Date Prepared

October 20, 2017

Device Names/Classification

Device Name:	GORE® ENFORM Biomateria
Classification Name:	Mesh, surgical, polymeric
Regulation:	21CFR 878.3300
Classification:	Class II
Product Code:	OXF, OWT, OWZ, OXC

Predicate Devices

. K163217 GORE® BIO-A® Tissue Reinforcement
K152609 GORE® SYNECOR Intraperitoneal Biomaterial ●
K143380 BARD® Phasix™ ST Mesh

Device Description

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Indications for Use

Differences in Technological Characteristics

The GORE® ENFORM Biomaterial with film configuration, a fully absorbable device, contains a visceral protection film layer not present in the predicate GORE® BIO-A® Tissue Reinforcement. However, the GORE® SYNECOR Intraperitoneal predicate possesses a visceral protection film comprised of the same material as the GORE® ENFORM Biomaterial with film. (The permanent PTFE knit middle layer of the predicate GORE® SYNECOR is not present in the GORE® ENFORM Biomaterial devices and therefore, was not compared.) The predicate PHASIX™ ST, also a fully absorbable device, possesses a visceral protection layer comprised of a different material (hvdrogel barrier).

Summary of Performance Testing

Biocompatibility: Biocompatibility evaluation appropriate for a tissue contacting implant with permanent duration of exposure was conducted according to "Use of International Standard /SO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Guidance for Industry and Food and Drug Administration Staff. June 16, 2016".

Bench study: The bench testing conducted but was not limited to evaluation of surgical manipulation, suture needle penetration, stiffness, tensile strength. Results demonstrated that both configurations of the GORE® ENFORM Biomaterial met the performance criteria established for the indicated uses of the device.

Animal study: Animal studies were conducted to compare the performance of the ENFORM Biomaterial to the predicate control devices with respect to visceral protection, tissue ingrowth and tissue response.

Conclusion

The information and test results contained within this 510(k) premarket notification demonstrate that the subject GORE® ENFORM Biomaterial device is substantially equivalent to the predicate devices in terms of indications for use, design, materials, biocompatibility, sterilization, packaging, and performance.

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.