PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film.

AI/ML Overview

Acceptance Criteria and Device Performance Study for PROCEED* Trilaminate Surgical Mesh

The provided document describes the predicate equivalence of the PROCEED* Trilaminate Surgical Mesh. The nature of this submission (a 510(k) for a medical device) means that the "acceptance criteria" are primarily related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance metrics with predefined thresholds like a diagnostic AI model.

The study presented focuses entirely on non-clinical laboratory and in-vivo animal testing to demonstrate comparability and intended performance. It does not involve human readers, AI algorithms, or clinical trials with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate)	Reported Device Performance (Summary of Findings)
Technological Characteristics: The device should have similar technological characteristics to the predicate devices.	PROCEED* has similar technological characteristics as the predicate devices. The addition of an Oxidized Regenerated Cellulose (ORC) layer to the standard base surgical mesh material is common to other predicate devices (W.L. GORE & Associates, Inc. DualMesh Biomaterial (K963619), the Genzyme Corp. Sepramesh Biosurgical Composite (K994328) and the Bard Composix** Mesh (510K K971745), with a performance characteristic of minimizing tissue attachment to the base mesh material. With the addition of the ORC layer, the PROCEED* Mesh continues to meet the functional requirements of a surgical mesh.
Performance: The device should perform comparably to standard surgical mesh devices indicated for hernia repair and other fascial deficiencies.	Non-clinical laboratory testing was performed, demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Additionally, in-vivo testing was provided, showing that the device performed as intended and as claimed.
Intended Use/Indications: The device's intended use and indications for use should be consistent with predicate devices.	The intended use for PROCEED* Mesh is for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result, which is consistent with the predicate device (PROLENE Soft Polypropylene Mesh) and other similar mesh products.

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

The document specifies non-clinical laboratory testing and in-vivo testing.

Sample size for test set: Not explicitly stated. The nature of the non-clinical lab and in-vivo testing (which implies animal studies in this context) would typically involve specific numbers of samples or animals, but these are not provided in this summary.
Data provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would primarily be generated by the manufacturer (Ethicon, Inc.) through their own testing facilities or contracted labs. The "in-vivo testing" suggests animal studies were conducted. It is retrospective in the sense that the testing was completed before the submission.

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

This question is not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for a surgical mesh device would be derived from physical property measurements and biological responses in animal models, not expert interpretations of data.

4. Adjudication method for the test set

This question is not applicable. There is no adjudication method described as the study does not involve human interpretation or consensus for a test set.

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 study is for a surgical mesh and does not involve AI assistance, human readers, or diagnostic performance evaluation.

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

No, a standalone (algorithm only) performance study was not done. This study is for a surgical mesh and does not involve any algorithms or AI.

7. The type of ground truth used

The ground truth used for this type of device would be:

Benchtop Data: Physical and mechanical properties of the mesh (e.g., tensile strength, pore size, burst strength, pliability) compared to predicate devices and engineering specifications.
In-vivo (Animal) Data: Biological response and performance in animal models (e.g., tissue integration, adhesion formation, inflammatory response, degradation profile, functional outcome related to hernia repair).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI surgical device. All testing described falls under verification and validation activities.

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

This question is not applicable, as there is no training set mentioned or implied by the type of device and study.

Summary

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KO31925 (1. 1982)

SECTION 8 SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary	Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.NEW DEVICE NAME: PROCEED* Surgical MeshPREDICATE DEVICES NAME: PROLENE Soft Polypropylene Mesh.
Device Description	PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film.
Intended Use	PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications Statement	PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
TechnologicalCharacteristics	PROCEED has similar technological characteristics as thepredicate devices. The addition of another layer to thestandard base surgical mesh material is common to theW.L. GORE & Associates, Inc. DualMesh Biomaterial(K963619), the Genzyme Corp. Sepramesh BiosurgicalComposite (K994328) and the Bard Composix** Mesh(510K K971745) with a performance characteristic ofminimizing tissue attachment to the base mesh material.With the addition of the ORC layer to minimize tissueattachment to the base PROLENE Soft Mesh, thePROCEED Mesh continues to meet the functionalrequirements of a surgical mesh
Performance Data	Non-clinical laboratory testing was performeddemonstrating that the device is comparable to standardsurgical mesh devices that are indicated for hernia repairand other fascial deficiencies that require the addition of areinforcing or bridging material to obtain that desiredsurgical result. Additionally, in-vivo testing was providedshowing that the device performed as intended and asclaimed.
Conclusions	Based on the 510(k) summaries and 510(k) statements (21CFR 807) and the information provided herein, weconclude that the modified device is substantiallyequivalent to the Predicate Devices under the Federal Food,Drug, and Cosmetic Act.
Contact	Rey LibrojoSenior Project Manager, Regulatory AffairsETHICON ProductsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151
Date	September 3, 2003

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ψ31925 (P. 20A2)

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Image /page/2/Picture/1 description: The image shows a stylized drawing of three birds in flight, arranged closely together. The birds are depicted with simple, curved lines, giving them a sense of movement. A dotted circle partially surrounds the birds, adding a sense of enclosure or focus to the composition. The drawing is in black and white, with a minimalist aesthetic.

food and Drug 200 Corporate Boute Rockville MD 20050

SEP 1 7 2003

Mr. Rev Librojo Senior Project Manager, Regulatory Affairs Ethicon, Inc. Rt. #22 West Somerville, New Jersey 08876-0151

Re: K031925

Trade/Device Name: PROCEED* Trilaminate Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: June 20, 2003 Received: June 27, 2003

Dear Mr. Librojo:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Rey Librojo

This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K431925

Device Name:

Indications for Use:

PROCEED* Trilaminate Surgical Mesh

PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

, i

Over-The Counter Use

(Optional Format 1-2-9G)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K031925 510(k) Number_

Page iii

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.