PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

PREMIUM medical devices are surgical meshes with light polypropylene. They are non resorbable parietal reinforcement implants.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "PREMIUM", which is a surgical mesh. The document details the device's characteristics, intended use, and a summary of performance data to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it refers to conformance with a special control "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh." The reported device performance is that it "conforms to the special control" and the testing "demonstrates that PREMIUM is as safe, as effective, and performs as safety and effectively as its predicate devices."

The specific tests performed are listed, with the implicit acceptance being that the results are comparable or equivalent to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Conforms to "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh"	PREMIUM conforms to the special control guidance.
Tensile strength comparable to predicate	Performed. Implicitly comparable or equivalent to predicate.
Stiffness comparable to predicate	Performed. Implicitly comparable or equivalent to predicate.
Suture pullout strength comparable to predicate	Performed. Implicitly comparable or equivalent to predicate.
Burst strength comparable to predicate	Performed. Implicitly comparable or equivalent to predicate.
Tear resistance comparable to predicate	Performed. Implicitly comparable or equivalent to predicate.
As safe, effective, and performs as safely and effectively as predicate devices.	Non clinical performance testing demonstrated that PREMIUM is as safe, as effective, and performs as safely and effectively as its predicate devices.

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

The document states: "No clinical data has been presented." This means that the testing was non-clinical. Therefore, there is no test set in the sense of patient data. The "test set" likely refers to the samples of the PREMIUM surgical mesh used for the physical and mechanical property testing.

Sample Size: Not specified for each test (Tensile strength, Stiffness, etc.).
Data Provenance: Not applicable as no clinical data was used. The testing was laboratory-based, likely performed by the manufacturer (Cousin Biotech).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Since "No clinical data has been presented," there was no need for experts to establish ground truth on a patient test set. The ground truth for the non-clinical performance tests would be established by validated test methods and reference standards, interpreted by engineers or technicians.

4. Adjudication Method for the Test Set

Not applicable. As no clinical data was used, there was no need for an adjudication method by medical experts for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this non-clinical submission is based on physical and mechanical property measurements of the device (PREMIUM surgical mesh samples). The performance is compared against the known properties and established safety/effectiveness profile of the predicate device (PROLENE SOFT), which presumably has its own performance data and regulatory history. The "acceptance criteria" are implied by conformance to a specific FDA guidance document for surgical meshes, which outlines the required non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm. The "training" for the manufacturing process would refer to quality control and process validation, which is not detailed here.

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

Not applicable, as there is no training set for an algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 4, 2014

Cousin Biotech Mr. Frank Pelletier Regulatory Affairs Director 8 Rue de L'Abbé Bonpain F 59117 Wervicq-Sud, France

Re: K133889

Trade/Device Name: Premium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 31, 2014 Received: August 4, 2014

Dear Mr. Pelletier:

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 (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

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

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Abbreviated 510k PREMIUM

Image /page/2/Picture/1 description: The image shows the word "COUSIN" in large, white, block letters with a black outline. The word is centered over a green diamond shape. Below the word "COUSIN" is a smaller, faded word that appears to be "baseball".

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: PREMIUM Indications for Use:

PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Prescription Use✓	AND/OR	Over-The-Counter Use__________
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Abbreviated 510k

TOUSIN

PREMIUM

510(k) SUMMARY

As required by section 807.92(c)

Submitter	COUSIN BIOTECH
	8 rue de l'Abbé Bonpain
	F59117 WERVICQ SUD FRANCE
Contacts	Franck PELLETIER Regulatory Affairs Directorf.pelletier@cousin-biotech.com
Preparation date	18 December 2013
Trade Name	PREMIUM
Common Name	POLYMERIC SURGICAL MESH
Classification Name	MESH SURGICAL POLYMERIC
Regulation number	878.3300
Product code	FTL
Class	II
Legally marketedpredicate devices	PREMIUM is compared to PROLENE SOFT (K001122)manufactured by ETHICON, INC.
Description	PREMIUM medical devices are surgical meshes withlight polypropylene. They are non resorbable parietalreinforcement implants.
Intended Use	PREMIUM devices are surgical meshes that areindicated for the repair of hernia or other fascialdefects that require the addition of a reinforcing orbridging material to obtain the desired surgical result.
Performance data	PREMIUM conforms to the special control "Guidancefor the Preparation of a Premarket NotificationApplication for a Surgical Mesh". Testing include:Tensile strength, Stiffness, Suture pullout strength,Burst strength and Tear resistance.No clinical data has been presented.

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Abbreviated 510k PREMIUM

Image /page/4/Picture/1 description: The image shows the word "COUSIN" in a stylized font. The word is white with a black outline, and it is set against a green diamond shape. The diamond shape is slightly blurred, and the word "COUSIN" is the main focus of the image.

Substantialequivalence
	PREMIUM is substantially equivalent to its predicateddevices in terms of intended use, material, design,mechanical properties and function. Non clinicalperformance testing according to special controldemonstrates that PREMIUM is as safe, as effective,and performs as safety and effectively as its predicatedevices.

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.