The provided text describes the 510(k) Premarket Notification for the GYNECARE PROLENE Fastener System. This document focuses on establishing substantial equivalence to predicate devices through various performance tests, primarily mechanical and in-vivo evaluations of the fastener's strength and attachment capabilities.

The primary goal of this submission is not to validate an AI/ML device, but rather a medical device (a surgical fastener). Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) are not applicable or extractable from this type of document.

The document describes engineering bench testing and an in-vivo comparison study, which are standard for physical medical devices.

Here's the information that can be extracted or inferred from the provided text, adapted to the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format. Instead, it lists various performance tests conducted to demonstrate safety and performance, implying that the device successfully met the requirements of these tests for substantial equivalence. The "reported device performance" is qualitative – the device passed these tests.

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Design Verification of the GYNECARE PROLENE Fastener with a Distributed Load	Device performs as intended under distributed load	Met (Supported substantial equivalence)
Design Verification of the GYNECARE PROLENE Fastener with a Point Load	Device performs as intended under point load	Met (Supported substantial equivalence)
Design Verification for the Tensile Strength of the GYNECARE PROLENE Fastener with GYNECARE GYNEMESH* PS	Device exhibits adequate tensile strength with mesh	Met (Supported substantial equivalence)
In-Vivo Comparison Between the Tissue Pullout Force of Suture and the GYNECARE PROLENE Fastener	Fastener's tissue pullout force is comparable/superior to suture	Met (Supported substantial equivalence)
Holding Strength of the GYNECARE PROLENE Fastener in the Sacrospinous Ligament	Device provides adequate holding strength in the sacrospinous ligament	Met (Supported substantial equivalence)

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

Sample Size for Test Set: Not explicitly stated in the provided text. For mechanical testing, this typically refers to the number of fasteners or constructs tested in each experimental arm. For the in-vivo comparison, it would refer to the number of subjects (animals or cadaveric specimens) or sites studied.
Data Provenance: Not explicitly stated. For in-vitro (bench) testing, the data is generated in a lab setting. For the in-vivo comparison, it's likely institutional, but the country of origin or whether it's retrospective/prospective is not mentioned.

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

This is not applicable for this type of device submission. Ground truth, in the context of physical device performance, is established through direct measurement (e.g., force, displacement) by engineers and scientists, not through expert consensus of visual data.

4. Adjudication Method for the Test Set

This is not applicable. As there is no "ground truth" established by experts in the sense of image interpretation, there is no adjudication method needed. Results are typically objectively measured and analyzed statistically.

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 is not applicable as the device is a surgical fastener, not an AI/ML diagnostic tool or an imaging system requiring human interpretation.

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

This is not applicable as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be objective scientific measurements from the mechanical testing and the in-vivo comparison.

Mechanical Tests: Ground truth is established by physical measurement of forces, displacements, and material properties.
In-Vivo Comparison: Ground truth is established by measurable biological or biomechanical outcomes reported in the study (e.g., tissue pullout force observed in live tissue or cadaveric models).

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device and does not involve AI/ML models that require a "training set."

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

This is not applicable for the same reason as above.

Summary

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

HICON, inc. GYNECARE PROLENE Fastener System

DEC 2 2 2004

K042603
510(k) Premarket Notification
December 20, 2004

510(k) Summary

Trade Name:	GYNECARE PROLENE Fastener System
Sponsor:	ETHICON, inc.Route 22 WestSomerville, NJ 08876
Contact:	Sean O'Bryan, Senior Project Manager, Regulatory Affairs; Tel: 908-218-2456
Device Generic Name:	Implantable staple, nonabsorbable (21 CFR 878.4750)
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Product Code:	PBQ
Predicate Device(s):	ETHIBOND EXCEL suture - NDA 17-804ETHICON PROLENE suture - NDA 16-374
Product Description:	The GYNECARE PROLENE Fastener consists of the implantablenonabsorbable PROLENE polypropylene Fastener.

Indications for Use:

The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, non-woven surgical mesh and suture to ligaments of the pelvic floor.

Safety and Performance:

The following safety and performance data has been provided to support substantial equivalence of the GYNECARE PROLENE Fastener System:

Performance testing:

Design Verification of the GYNECARE PROLENE Fastener with a Distributed Load .
Design Verification of the GYNECARE PROLENE Fastener with a Point Load .
Design Verification for the Tensile Strength of the GYNECARE PROLENE Fastener with . GYNECARE GYNEMESH* PS
. Design Verification for the In-Vivo Comparison Between the Tissue Pullout Force of Suture and the GYNECARE PROLENE Fastener
Holding Strength of the GYNECARE PROLENE Fastener in the Sacrospinous Ligament .

Conclusion:

Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, the GYNECARE Fastener System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with three curved lines representing its wings. 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 Center - WO66-G609 Silver Spring, MD 20993-0002

February 1. 2013

ETHICON, Inc. % Mr. Sean O'Bryan Senior Project Manager, Regulatory Affairs Route 22 West SOMERVILLE NJ 08876

Re: K042603

Trade/Device Name: Gynecare Prolene Fastener System Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: PBQ Dated (Date on orig SE ltr): November 18, 2004 Received (Date on orig SE ltr): November 22, 2004

Dear Mr. O'Bryan:

This letter corrects our substantially equivalent letter of December 22, 2004.

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

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

Page 2 - Mr. Sean O'Bryan

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 (OS) 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" (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/Safetv/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

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

K042603

Indications for Use

510(k) Number (if known): K042603

Device Name: GYNECARE PROLENE Fastener System

Indications For Use:

The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor.

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)

Muriam C. Provost

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

510(k) Number K042603

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.