The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

Device Description

The AMS Pelvic Floor Repair System consists of needles and mesh used to repair the pelvic floor.

AI/ML Overview

The provided text is a 510(k) summary for the AMS Pelvic Floor Repair System. Unfortunately, it does not contain the detailed information required to answer your specific questions about acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

The "Summary of Testing" section is very brief, stating only: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices."

This highlights a common characteristic of 510(k) summaries, which often focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo performance studies against specific acceptance criteria. For devices cleared through the 510(k) process, the primary "acceptance criterion" is usually a finding of substantial equivalence to a legally marketed predicate.

Therefore, many of your questions cannot be answered from the provided document. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Information (Based on the Provided Text)

Information Category	Details from Document
1. Acceptance Criteria and Reported Device Performance	Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching "acceptance criterion" for 510(k) clearance is substantial equivalence to predicate devices. Reported Device Performance: The document states: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices." No specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility results) are provided or compared against acceptance criteria.
2. Sample Size for Test Set & Data Provenance	Not provided. The summary just generally mentions "testing" without detailing the nature of the tests (e.g., clinical, bench, animal) or the sample sizes involved.
3. Number of Experts & Qualifications for Ground Truth	Not applicable/provided. This device is a surgical mesh; the "ground truth" would typically refer to clinical outcomes, mechanical properties, or biocompatibility, not expert interpretation of diagnostic images.
4. Adjudication Method	Not applicable/provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study	No. This device is a surgical mesh, not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only)	No. This device is a surgical mesh, not an algorithm. Performance would relate to its physical and biological properties.
7. Type of Ground Truth Used	Not explicitly stated. For a surgical mesh, "ground truth" would likely involve: - Bench testing results: Mechanical strength, pore size, material composition, etc. - Biocompatibility testing: In vitro and/or in vivo studies. - Animal studies: To assess in-vivo performance and host response. - Clinical outcomes: From studies on the predicate devices or potentially early clinical use if available (though not detailed here).
8. Sample Size for Training Set	Not applicable/provided. This is not a machine learning device.
9. How Ground Truth for Training Set Was Established	Not applicable/provided.

Summary

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AUG 3 - 2005

510(k) Summary AMS Pelvic Floor Repair System

510(k) Number_Ko51485

Date of Summary Preparation:

June 3, 2005

Submitter/Contact Person:

Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343

Phone: (952) 930-6000 Fax: (952) 930-6496

Device Name and Classification:

Trade Name: AMS Pelvic Floor Repair System Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTO, OTO, OTP Classification: Class II

Manufacturing Location:

American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343

Predicate Devices:

AMS Apogee - K040537 AMS Perigee - K040623 AMS Pre-Connected Apogee, Perigee, & BioArc - K050445 AMS Porcine Dermis - K050445 AMS Sparc Sling System -K021263 AMS Monarc Sling System - K023516 AMS Silicone-Coated Sling and Surgical Mesh - K002721 AMS Large Pore Polypropylene Mesh - K040521

Indications for Use:

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Device Description:

vice Description.
The AMS Pelvic Floor Repair System consists of needles and mesh used to repair the pelvic floor.

Summary of Testing

minary of Testing
The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

Ms. Elsa A. Linke Senior Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 20:2

Re: K051485 Trade/Device Name: AMS Pelvic Floor Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO, OTP Dated: June 3, 2005 Received: June 6, 2005

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of August 3, 2005.

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.

Sincerely yours,

Benjamin R. Perkins

Beniamin 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: AMS Pelvic Floor Repair System

Indications For Use: The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following gastrological and and myport, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eda

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

Neurological Devices

510(k) Number K051445

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Page 18 of 133

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.