The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Description

The GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut non-absorbable mesh implants and a set of instruments to facilitate mesh implant placement.

The GYNECARE PROLIFT+M Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement.

AI/ML Overview

The provided text is a 510(k) summary for the GYNECARE PROLIFT and GYNECARE PROLIFT+M Pelvic Floor Repair Systems. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the typical sense of a novel algorithm or diagnostic device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets cannot be fully extracted from this document in the way it would for a machine learning or diagnostic device.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) with associated thresholds as might be seen for a diagnostic device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, focusing on material properties and functional testing, aligning with the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

Acceptance Criteria (Implied)	Reported Device Performance
Material Biocompatibility (as per ISO 10993-1)	Assessed using methods specified in ISO 10993-1; materials were found to be acceptable for their intended uses.
Functional Performance (bench and cadaver testing)	Results indicate that the proposed device meets or exceeds all functional requirements, based on FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
Technological Characteristics (similarity to predicate devices)	GYNECARE PROLIFT: Implantable component is a sterile, mesh implant intended for repair of pelvic floor defects. Mesh implant is made of non-absorbable polymers, identical to those in GYNECARE GYNEMESH PS (predicate). GYNECARE PROLIFT+M: Implantable component is a sterile, mesh implant intended for repair of pelvic floor defects. Mesh implant is made of non-absorbable and absorbable polymers, identical to those in ULTRAPRO Mesh (predicate). The modified devices have similar technological characteristics as the predicate devices.
Intended Use (similarity to predicate devices)	The stated indications for use are consistent with (or slightly expanded from) the predicate devices, for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench and cadaver testing" and "preclinical modelling" for functional performance. It does not provide specific sample sizes for these tests, nor does it detail data provenance (e.g., number of cadavers, specifics of bench tests). This is typical for a 510(k) submission focused on mechanical and material properties rather than clinical performance data from patient populations.

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 applicable and hence not provided. The "ground truth" here relates to the material and functional properties meeting engineering specifications and biocompatibility standards, not to interpretations by medical experts as in a diagnostic study.

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

Not applicable. This is not a study requiring expert adjudication of cases.

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 such study was conducted or mentioned, as this is not an AI/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

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

The "ground truth" relates to:

Biocompatibility: Conformance to ISO 10993-1 standards, which involves various biological tests (e.g., cytotoxicity, sensitization, irritation).
Functional Performance: Meeting established engineering and functional requirements for surgical mesh, likely based on validated test methods and established in FDA guidance.
Material Composition: Verification of the chemical and physical properties of the polymers to ensure they are identical or equivalent to those in the predicate devices.

8. The sample size for the training set

Not applicable. There is no machine learning "training set" for this type of device.

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

Not applicable. There is no machine learning "training set" for this type of device.

Summary

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K071512
pg 1 of 2

Summary of Safety and Effectiveness

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

Submitted by:

Bryan A. Lisa Regulatory Affairs Project Manager ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

MAY 1 5 2008

Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (0TP) Class I in 21 CFR § 878.4800, Manual surgical instrument for general use

Trade Name:

GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems

Predicate Devices:

GYNECARE GYNEMESH PS* PROLENE* Soft Mesh (ETHICON, Inc.) K013718 .
ULTRAPRO* Mesh (ETHICON, Inc.) K033337
AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) K040537
AMS PERIGEE System (American Medical Systems, Inc.) K040623 .

Statement of Intended Use:

The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH PS* PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Description:

The GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut non-absorbable mesh implants and a set of instruments to facilitate mesh implant placement. The following table summarizes the instruments included with each system:

510(k) Summary

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REPAIR SYSTEM	COMPONENTS
	Mesh Implant	Guide	Retrieval Devices	Cannulas
Total	1 Total	1	6	6
Anterior	1 Anterior	1	4	4
Posterior	1 Posterior	1	2	2

The GYNECARE PROLIFT+M Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement. The following table summarizes the instruments included with each system:

1071512

2022

REPAIR SYSTEM	COMPONENTS
	Mesh Implant	Guide	Retrieval Devices	Cannulas
Total	1 Total	1	6	6
Anterior	1 Anterior	1	4	4
Posterior	1 Posterior	1	2	2

Summary of Technological Characteristics of New Device to Predicate Devices:

The modified devices have similar technological characteristics as the predicate devices.

GYNECARE PROLIFT: Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of pelvic floor defects. The mesh implant component of the proposed device is made of nonabsorbable polymers, which are identical to those found in GYNECARE GYNEMESH PS, currently marketed by ETHICON, Inc. ....

GYNECARE PROLIFI+M: Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of pelvic floor defects. The mesh implant component of the proposed device is made of nonabsorbable and absorbable polymers, which are identical to those found in ULTRAPRO Mesh, currently marketed by ETHICON, Inc.

Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1. and the materials were found to be acceptable for their intended uses. Results of functional performance testing (bench and cadaver testing) indicate that the proposed device meets or exceeds all functional requirements, based on FDA's Guidance Document "Guidance for the Preparation of a Premarket Notification Arplication for a Surgical Mesh". Preclinical modelling was used to evaluate procedural performance of the systems.

Conclusions:

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

Trademark of ETHICON, Inc.

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Image /page/2/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 eagle with its wings outstretched, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.

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

SEP 2 8 2012

Ethicon, Inc. % Mr. Bryan A. Lisa Route 22 West P.O. Box 151 SOMERVILLE NJ 08876

Re: K071512

Trade/Device Name: Gynecare Prolifi™ Total, Anterior, and Posterior Pelvic Floor Repair Systems; Gynecare Prolift +MTM Total, Anterior, and Posterior Pelvic Floor Repair Systems

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: February 22, 2008 Received: February 25, 2008

Dear Mr. Lisa:

This letter corrects our substantially equivalent letter of May 15, 2008.

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 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/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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BAL-2007-002

Indications for Use

510(k) Number (if known): K071512

Device Name: GYNECARE PROLIFT* and GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems

Indications for Use:

*Trademark.

(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)

NILREOL for reims

Division of General, Restorative, and Neurological Devices

510(k) Number K071512

INDICATIONS FOR USE

ETHICON CONFIDENTIAL

Regulation Number and Section

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.