The STRATASISTM Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The STRATASISTM Sling Kit is composed of a strip of SIS material with TEVDEK® suture attached to each end. Two stainless steel ligature carriers are also included.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the STRATASIS™ Sling Kit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with quantitative performance metrics. Therefore, the information typically requested in your prompt (e.g., specific performance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader studies, ground truth types) is not present in the provided document, as it is generally not required for a 510(k) summary focused on substantial equivalence based on materials, construction, and intended use.

However, I can extract information related to the "tests" performed and the "conclusions drawn," which are the closest equivalents to demonstrating criteria satisfaction in this context.

Here's a breakdown of what can be extracted and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility requirements met	The STRATASISTM Sling Kit met the requirements of all tests.
Disinfection requirements met	The STRATASISTM Sling Kit met the requirements of all tests.
Performance characteristics met	The STRATASISTM Sling Kit met the requirements of all tests.
Substantial equivalence to predicate devices in terms of indications for use, materials, and physical construction.	The STRATASISTM Sling Kit is similar in terms of substantial equivalence to predicate devices (SUROISIS Sling, SIS Hernia Repair Device, Tension Free Vaginal Tape) with respect to indications for use, materials, and physical construction.

Explanation: The 510(k) summary only states that the device "met the requirements of all tests" for biocompatibility, disinfection, and performance characteristics. It does not provide specific quantitative acceptance thresholds or detailed performance outcomes for these tests. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a 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)

This information is not provided in the document. 510(k) summaries for devices like surgical meshes typically do not include clinical study details of this nature unless a de novo classification or complex performance data is required. The "tests" mentioned are likely bench tests and material characterization, not patient-based test sets.

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)

This information is not provided as there is no mention of a clinical test set or ground truth established by experts. The "tests" refer to laboratory and material evaluations.

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

This information is not provided as there is no mention of a clinical test set or 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

This information is not applicable/provided. The device is a surgical sling, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable/provided. The device is a surgical sling, not an algorithm.

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

This information is not provided. For a surgical mesh, ground truth is typically assessed through detailed material testing, biocompatibility studies, and in some cases, animal model or clinical trial outcomes to demonstrate safety and efficacy. However, for a 510(k) of this nature, detailed outcomes data acting as "ground truth" for a performance study is usually not the primary focus, especially when substantial equivalence to well-established predicates is the claim.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical surgical implant, not an AI model that requires a training set.

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

This information is not applicable/provided. The device is a physical surgical implant, not an AI model.

In summary: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" of the STRATASISM Sling Kit to existing predicate devices based on its intended use, materials, and physical construction. It confirms that the device underwent and met requirements for biocompatibility, disinfection, and performance characteristics through un-detailed "tests." It does not contain the kind of detailed performance data, clinical study specifics, or AI-related information requested, as that is not typically part of a 510(k) premarket notification for a device of this type in 2002.

Summary

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510(k) Premarket Notification: STRATASISTM Sling Kit

K020654

9. 510(k) SUMMARY

APR = 9 2002

Submitted By: Mark Blever, President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 (765) 497-3355

Device:

Trade Name: Common/Usual Name: Proposed Classification Name:

STRATASISTM Sling Kit Surgical Mesh, Urethral Sling Surgical Mesh ( PAG)

Intended Use:

Predicate Devices:

The STRATASISTM Sling Kit is similar in terms of substantial equivalence to the following predicate devices: SUROISIS Sling (K992159) manufactured by Cook Biotech Incorporated; the SIS Hernia Repair Device (K974540) manufactured by Cook Biotech Incorporated, and Tension Free Vaginal Tape (K974098) marketed by GYNECARE.

Device Description:

The STRATASISTM Sling Kit is composed of a strip of SIS material with TEVDEK® suture attached to each end. Two stainless steel ligature carriers are also included.

Substantial Equivalence:

The STRATASISTM Sling Kit is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalence.

Discussion of Tests and Test Results:

The STRATASISTM Sling Kit was subjected to a panel of tests to assess biocompatibility, disinfection, and performance characteristics. The STRATASISTM Sling Kit met the requirements of all tests.

Conclusions Drawn from Tests:

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

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures are visible in the negative space within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

SEP 2 8 2012

Mr. Mark Blever President Cook Biotech, Inc. 3055 Kent Avenue WEST LAFAYETTE IN 47906

Re: K020654 Trade/Device Name: STRATASISTM Sling Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: February 27, 2002 Received: February 28, 2002

Dear Mr. Bleyer:

This letter corrects our substantially equivalent letter of April 9, 2002.

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 (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 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Perkins

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

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KO20654 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ STRATASIS™ Sling Kit

Indications For Use:

The STRATASIS™ Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K020654

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

Over-The-Counter Use

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.