The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Device Description

The AMS Triangle™ Siliconc-Coated Sling and Surgical Mesh is made of a The AMS THangle - Omeone with a thin layer of solid silicone elastomer. The polyester mesil that is obverted the Sling and Surgical Mesh is available in sizes AMO Triangle - Binoo.144 cm2, including 2 cm x 5 cm, 2 cm x 4 cm, 2 cm x 10 cm, 2 cm x 7 cm, 2 cm x 20 cm, 6 cm x 6cm and 12 cm x 12cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AMS Triangle™ Silicone-Coated Sling and Surgical Mesh. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with acceptance criteria and detailed study results as would be typical for pharmaceuticals or novel high-risk devices.

Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical outcome or diagnostic performance is not applicable in this context. The "study" mentioned here refers to material property tests to demonstrate equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance
Biocompatibility	Equivalent to predicate devices	"Demonstrated to be biocompatible."
Physical Characteristics (e.g., tensile strength, suture pull strength)	Equivalent to predicate devices	"Has been shown to be equivalent to the listed predicate devices."

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

Test Set Sample Size: Not applicable in the context of a clinical test set. The "test set" here refers to the AMS Triangle™ material and its physical properties. No specific number of units tested is provided, nor is a 'test set' in the traditional clinical performance sense mentioned.
Data Provenance: Not applicable. The tests were material property tests, not based on human data or retrospective/prospective studies on patients.

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

Not applicable. Ground truth in a clinical or diagnostic sense is not relevant for material property testing. The "ground truth" was established by comparing the AMS Triangle™'s material properties against those of the established predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for a 510(k) submission focused on material equivalence.

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

Not applicable. This device is a surgical mesh/sling; there is no "algorithm" or standalone AI performance to evaluate.

7. The Type of Ground Truth Used

Engineering/Material Ground Truth: The physical and biocompatibility properties of the predicate devices (TriAngleTM Sling - K980482, Bard® Marlex Mesh - K922916, Ethicon™ Prolene™ Mesh - K962530, Mersilene™ Mesh Mentor SUSPEND™ Sling - K980483) served as the "ground truth" or benchmark for comparison. The AMS Triangle™ was tested to show it met equivalent performance to these established devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/machine learning model. The concept of a "training set" doesn't apply to this type of medical device submission.

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

Not applicable, as there is no training set.

Summary

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NOV 2 9 2000

510(k) Summary AMS Triangle™ Silicone-Coated Sling and Surgical Mesh 510(k) Number K002721

Submitter/Contact Person:

Ginger Sackett Glaser Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343

Phone: (952) 930-6541 Fax: (952) 930-6496 Email: ginger glaser@visitams.com

Device Name and Classification:

Trade Name: AMS Triangle™ Silicone-Coated Sling and Surgical Mesh Common/Usual Name: Surgical Mesh, Sling, Urethral Sling Classification Name: Surgical Mesh, polymeric Product Code: FTL Classification: Class II

Manufacturing Location:

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

Predicate Devices:

TriAngleTM Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh Mentor SUSPEND™ Sling - K980483

Indications for Use:

The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse publication and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

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Device Description:

Summary of Testing

The material used in the AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been demonstrated to be biocompatible.

The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh has been I ne Ario Trange of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2000

Ms. Ginger S. Glaser *Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West Minnetonka, Minnesota 55343

K002721 Re:

Trade Name: AMS Triangle Silicone-Coated Sling and Surgical Mesh

Regulatory Class: II Product Code: FTL Dated: August 24, 2000 Received: August 31, 2000

Dear Ms. Glaser:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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)." 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Ginger S. Glaser

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow your to other substantial equivalence of your device to a premarket notification. - The PDF results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 -II you desire specific as for in vitro diagnostic devices), please contact the Office of and additionally 6091794-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. ad vertibing of your a regulation entitled, "Misbranding by reference to premarket Also, prease note togation of ther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:_AMS Triangle Silicone-Coated Sling and Surgical Mesh

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

to Mark N Milliner

(Division Sign-Off) Division of General Restorative Dev 510(k) Number.

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.