The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The proposed GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components: GYNECARE TVT EXACT™ Continence System Trocar and Trocar Sheath / Implant Assembly.

The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of PROLENE™Polypropylene Mesh (Implant) approximately 1/2 inch (1.1 cm) wide, 18 inches (45 cm) long , and approximately 0.027 inches (0.7 mm) thick, which is identical in material and dimensions to the implant of currently marketed GYRECARE TVT™ Device. The implant is covered by a clear plastic Implant Sheath and held between two white Trocar Sheaths, which are bonded to the Implant and Implant Sheath.

The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.

AI/ML Overview

The provided text describes the GYNECARE TVT EXACT™ Continence System, a surgical mesh device. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its effectiveness against specific acceptance criteria in the manner of a new drug or novel medical device requiring extensive clinical trials.

Therefore, the information required to populate all fields of your requested table and study description is not explicitly available in the provided document. The data mainly pertains to device design, materials, and functional equivalence to a previously approved device.

Here's an attempt to extract and infer information based on the provided text, highlighting where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material Equivalence	Implant material and dimensions identical to predicate device (PROLENE™ Polypropylene Mesh, ~1/2 inch wide, 18 inches long, ~0.027 inches thick).	The GYNECARE TVT EXACT™ Continence System Implant is "identical in material and dimensions to the implant of currently marketed GYRECARE TVT™ Device." (Page 21)
Principle of Operation	Principle of operation and fundamental scientific technology equivalent to predicate devices (GYNECARE TVT™).	"The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate devices." Both devices introduce a retropubic synthetic mesh sling for mid-urethral support. (Page 22)
Mechanical/Physical Testing	Established performance requirements for: - Key dimensions - Trocar Shaft Yield Force - Peak Torque of Trocar Shaft - Penetration Force - Lock Failure Force of Trocar Sheath	"Results of verification testing (such as measurement of key dimensions, Trocar Shaft Yield Force, Peak Torque of Trocar Shaft, Penetration Force, and Lock Failure Force of Trocar Sheath) indicates that modified device meets the established performance requirements." (Page 22) Specific thresholds or numerical results are not provided.
Intended Use	Indication for use as a pubourethral sling for female Stress Urinary Incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.	The device is intended for this use, and the FDA's "Indications for Use" enclosure confirms this. (Page 19, 4)
Substantial Equivalence	The device must be demonstrated substantially equivalent to the predicate device(s) in terms of safety and effectiveness.	"Based on the similarities to the predicate device identified in this submission as well as the outcome of design verification we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act." (Page 22)

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

Sample Size for Test Set: Not explicitly stated as this is a 510(k) submission primarily relying on design verification and equivalence to a predicate, rather than a clinical performance study with a distinct "test set" of patients in the context of AI/diagnostic device evaluation. The "test set" here refers to components/systems tested for mechanical properties. The document does not specify the number of devices or components subjected to the verification testing.
Data Provenance: The verification testing was conducted by Ethicon, Inc. (Johnson & Johnson Company). The country of origin of the data is not specified but would likely be the USA (where Ethicon is based) or facilities globally where their testing is performed. The data is retrospective in the sense that it's a summary of internal design verification testing, not a prospective clinical trial.

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

Number of Experts: Not applicable/not specified. The "ground truth" for this type of device (surgical mesh) is primarily based on engineering specifications and material science, and its performance is assessed through mechanical testing and comparison to an established predicate device. Clinical outcomes, while relevant for predicate approval, are not the focus of this 510(k) submission's comparative data.
Qualifications of Experts: Not specified. Design verification testing would be overseen by engineers and quality assurance personnel with relevant expertise in medical device manufacturing and testing standards.

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

Adjudication Method: Not applicable. This document describes design verification and substantial equivalence, not a clinical study with subjective interpretations requiring adjudication. Mechanical test results are typically quantitative and objective.

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

MRMC Study: No. This is a medical device (surgical mesh and delivery system), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and "human readers improving with AI" are not relevant or applicable to this submission.

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

Standalone Performance: Not applicable. This device is a physical surgical mesh and trocar system, not an algorithm.

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

Ground Truth Type:
- Engineering Specifications/Material Standards: For the physical properties (dimensions, forces, torque).
- Predicate Device Performance: The primary "ground truth" for this 510(k) is the established safety and effectiveness of the GYNECARE TVT™ Tension-free Vaginal Tape (K974098) as demonstrated through its prior approval and market history. The new device's performance is measured against the predicate device's characteristics and known performance.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Ground Truth Establishment (Training Set): Not applicable, as there is no training set for this type of device and submission. The "ground truth" for the overall substantial equivalence determination rests on the predicate device's established safety and effectiveness.

Summary of Device and Approval Context:

This document is a 510(k) Premarket Notification for a Class II medical device. The primary goal of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and either has the same technological characteristics as the predicate, or has different technological characteristics but is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness.

For the GYNECARE TVT EXACT™ Continence System, the demonstration of substantial equivalence relies heavily on:

Identical materials and dimensions for the mesh implant.
Equivalent principle of operation.
Verification testing to show the modified components (e.g., trocar, sheath) meet established performance requirements, implying they perform at least as well as or within acceptable limits compared to the predicate's components.

It's crucial to understand that a 510(k) submission generally does not require new large-scale clinical trials or detailed effectiveness studies if substantial equivalence can be shown through other means (e.g., bench testing, material comparisons, reliance on predicate's clinical history). The "acceptance criteria" here are those demonstrating this equivalence.

Summary

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4C100485

SL-2010-001

MAR 1 6 2010

Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

Submitted by:

Susan Lin Manager, Regulatory Affairs Ethicon, Inc., a Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh(OTN)

Trade Name:

GYNECARE TVT EXACT TM Continence System

Predicate Devices:

GYNECARE TVT™ Tension-free Vaginal Tape (K974098), ETHICON, Inc.

Statement of Intended Use:

Device Description:

The proposed GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components: GYNECARE TVT EXACT™ Continence System Trocar and Trocar Sheath / Implant Assembly.

TRUTHFUL & ACCURATE

ETHICON CONFIDENTIAL

PAGE 21 OF 61

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to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.

Summary of Technological Characteristics of New Device to Predicate Devices:

The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate devices. Both the GYNECARE TVT™ and the GYNECARE TVT EXACT™ function in the same manner -Introducing a retropubic synthetic mesh sling in the patient from a vaginal incision to the abdominal skin that provides mid-urethral support.

Performance Data:

Results of verification testing (such as measurement of key dimensions, Trocar Shaft Yield Force, Peak Torque of Trocar Shaft, Penetration Force, and Lock Failure Force of Trocar Sheath) indicates that modified device meets the established performance requirements.

Conclusions:

Based on the similarities to the predicate device identified in this submission as well as the outcome of design verification we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

TRUTHFUL & ACCURATE

ETHICON CONFIDENTIAL

PAGE 22 OF 61

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the profile of a human face. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Ms. Susan Lin Manager, Regulatory Affairs ETHICON, Inc. Route 22 West, P0 Box 151 SOMERVILLE NJ 08876

SEP 2 8 2012

K100485 Re: Trade/Device Name: GYNECARE TVT EXACT™ Continence System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: February 18, 2010 Received: February 19, 2010

Dear Ms. Lin:

This letter corrects our substantially equivalent letter of March 16, 2010.

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/CDRHVCDRHOffices/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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Indications for Use

510(k) Number (if known): __

Device Name: GYNECARE TVT EXACT™ Continence System

Indications for Use:

. . . . . . . .

Prescription Use	X	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)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K100485

ETHICON CONFIDENTIAL PAGE 19 OF 61

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.