The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is supplied sterile and is intended for one-time use.

Device Description

The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.

AI/ML Overview

This document is a 510(k) Summary for the Surgisis® Sling, a surgical mesh device. It does not provide information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or any other quantitative measures typically associated with AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

Intended Use: The Surgisis® Sling has the same intended use as its predicates (K980431, K954665, K980483, K963226).
Technological Characteristics: The device is stated to have the same technological characteristics as the predicate devices.
Testing for Biocompatibility, Integrity, and Performance: The document states that the Surgisis® Sling "passed the requirements of all tests" in these areas. However, it does not specify what these requirements or performance metrics were, nor does it provide the results of these tests in a detailed manner.

Therefore, I cannot provide the requested information for an AI/ML device as this document pertains to a traditional medical device (surgical mesh) where the evaluation criteria are different. The concept of "acceptance criteria" in this context refers to meeting the standards of biocompatibility, integrity, and equivalent performance to existing devices, rather than statistical performance metrics for an AI algorithm.

Summary of what can be extracted, and what cannot:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria (Implied): Biocompatibility, Integrity, Performance (in relation to predicate devices).
- Reported Device Performance: "The Surgisis® Sling passed the requirements of all tests." No specific quantitative performance metrics are provided.
Sample size used for the test set and data provenance:
- Not applicable/Not provided. The document refers to "tests" on the device itself (e.g., material properties), not a "test set" of patient data for an algorithm.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not provided. Ground truth in the context of an AI/ML device would involve annotations by experts on medical data. This document doesn't involve that.
Adjudication method:
- Not applicable/Not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study:
- Not applicable/Not performed. This is for evaluating AI assistance to human readers.
Standalone (algorithm only) performance:
- Not applicable/Not performed. This device is not an algorithm.
Type of ground truth used:
- Not applicable in the AI/ML sense. The "ground truth" for this device would be established engineering and biological standards for surgical mesh materials.
Sample size for the training set:
- Not applicable/Not provided. This document describes a physical medical device, not an AI algorithm.
How the ground truth for the training set was established:
- Not applicable.

In conclusion, the provided document describes a premarket notification (510(k)) for a conventional surgical mesh, focusing on substantial equivalence to existing devices. It does not contain the type of information related to acceptance criteria, test sets, ground truth, or study designs that would be relevant for an AI/ML medical device.

Summary

{0}------------------------------------------------

510(k) Summary

September 11, 2013

Cook Biotech Incorporated

Surgisis® Sling

Manufacturer Name:

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: +1 (765) 497-3355 FAX: +1 (765) 807-7709

Official Contact:

Perry W. Guinn

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations: Product Code:

Surgisis® Sling Surgical mesh Class II, 21 CFR §878.3300 PAG, PAJ, FTM

INTENDED USE:

PREDICATE DEVICES:

Surgisis® Mesh (K980431) manufactured by Cook Biotech Incorporated Glycar Staple Strips (K954665) manufactured by Glycar, Incorporated Mentor Suspend™ Sling (K980483) manufactured by Mentor Corporation Surgical Fabrics (K963226) manufactured by Boston Scientific

DEVICE DESCRIPTION:

The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.

{1}------------------------------------------------

K992159: Surgisis® Sling

SUBSTANTIAL EQUIVALENCE TO MARKETED DEVICES

The Surgisis® Sling is substantially equivalent to the predicate devices, having the same intended use and technological characteristics.

DISCUSSION OF TESTS AND TEST RESULTS:

The Surgisis® Sling was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The Surgisis® Sling passed the requirements of all tests.

CONCLUSIONS DRAWN FROM THE TESTS:

The device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

September 13, 2013

Cook Biotech Incorporated % Neal E. Fearnot, Ph.D. President 3055 Kent Avenue West Lafavette, IN 47906

Re: K992159 Trade/Device Name: Surgisis Sling

Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: PAG, PAJ, FTM Dated (Date on orig SE Itr): June 23, 1999 Received (Date on orig SE Itr): June 25, 1999

Dear Neal E. Fearnot, Ph.D.,

This letter corrects our substantially equivalent letter of September 23, 1999.

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 waranties. 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.

{3}------------------------------------------------

Page 2 - Neal E. Fearnot, Ph.D.

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K992159

Surgisis® Sling Device Name:

Indications For Use:

The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The device is supplied sterile and is intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Herbert P. Lerner -S

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.