The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ 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 pubourethral support and bladder support.

Device Description

The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is available in the size 4 cm x 7 cm. This pre-cut piece is mmbileono -------------------------------------------------------------------------------------------------------------------------------------------------------------------procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™.

Unfortunately, the provided text is a 510(k) summary for a medical device submitted to the FDA. While it discusses the device's indications for use, description, and states that testing was performed, it does not contain detailed information about specific acceptance criteria or the study data that "proves" the device meets those criteria, as one would expect in a clinical trial report or a more comprehensive study document.

510(k) summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or outlining detailed performance metrics against specific acceptance thresholds.

Therefore, many of the requested fields cannot be directly extracted from the provided document. I will fill in what can be inferred and explicitly state what information is not present.

Acceptance Criteria and Study for AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	(Not specified)	"The material used... has been demonstrated to be biocompatible."
Physical Characteristics (Tensile Strength)	(Not specified)	"has been shown to be equivalent to the listed predicate device."
Physical Characteristics (Suture Pull Strength)	(Not specified)	"has been shown to be equivalent to the listed predicate device."
Response to Antibiotics	(Not specified)	"Testing was also conducted to evaluate the response of tissues to the antibiotics." (No specific results or equivalence claim made here, only that testing was done).

Note: The document states "has been shown to be equivalent to the listed predicate device." This implies that the acceptance criteria for these physical characteristics were likely based on matching or falling within a specified range of the predicate device's performance. However, the specific numerical thresholds or ranges are not provided.

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not applicable. The "ground truth" here relates to physical and biological properties of the mesh, not human interpretation of medical images or conditions.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing described (biocompatibility, tensile strength, suture pull strength, response to antibiotics) are laboratory/benchtop tests, not a clinical review process.

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

No. This type of study is typically for evaluating diagnostic algorithms or imaging systems where human readers interpret data. The device is a surgical mesh.

6. If a Standalone Study (Algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The described testing (biocompatibility, physical characteristics, response to antibiotics) evaluates the device itself and its materials, without human clinical judgment in-the-loop during these specific tests. However, it's not "algorithm-only" performance as one might describe for AI/software, but rather standalone device performance testing.

7. The Type of Ground Truth Used

Biocompatibility: Established through standard biocompatibility testing methods (e.g., ISO 10993 series), which involves analytical chemistry, in vitro, and in vivo studies to assess biological response. The "ground truth" would be compliance with these standards and lack of adverse biological reactions.
Physical Characteristics (Tensile Strength, Suture Pull Strength): Established through standardized mechanical testing methods. The "ground truth" would be the measured physical properties of the material.
Response to Antibiotics: Established through laboratory testing (e.g., antimicrobial efficacy assays), likely comparing the release profile or inhibitory effect of the InhibiZone™ on target microorganisms or tissue response.

8. The Sample Size for the Training Set

Not applicable in the context of device performance testing. This concept is relevant for machine learning algorithms.

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

Not applicable.

Summary

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Page 1/2

DEC 1 4 2004

American Medical

510(k) Summary AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ ળીને વિવ 510(k) Number K

Submitter/Contact Person:

Kristyn M. Benson Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West Minnetonka, MN 55343

Phone: (952) 930-6072 Fax: (952) 930-6496 Email: kristyn benson@americanmedicalsystems.com

Device Name and Classification:

Trade Name: AMS InteMesh TM Silicone-Coated Sling and Surgical Mesh with InhibiZone™ Common/Usual Name: Surgical Mesh, Sling, Urethral Sling Classification Name: Surgical Mesh, polymeric Product Code: OTN Classification: Class II

Manufacturing Location:

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

Predicate Device:

AMS Triangle™ Silicone-Coated Sling and Surgical Mesh - K002721 Mentor SUSPEND™ Sling - K980483

Indications for Use:

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K042592 page 2/2

Device Description:

escription:
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is available in the size 4 cm x 7 cm. This pre-cut piece is mmbileono -------------------------------------------------------------------------------------------------------------------------------------------------------------------procedures.

Summary of Testing

/ or Testing
The material used in the AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ has been demonstrated to be biocompatible.

The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ has been tested for a variety of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate device. Testing was also conducted to evaluate the response of tissues to the antibiotics.

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its body and 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 Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Kristyn M. Benson Senior Regulatory Affairs Specialist American Medical Systems. Inc. 10700 Bren Road, West MINNETONKA MN 55343

SEP 2 8 2012

Re: K042592 Trade/Device Name: Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 11, 2004 Received: November 12, 2004

Dear Ms. Benson:

This letter corrects our substantially equivalent letter of December 14, 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

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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/CDRH0ffices/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. Fuchs

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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Image /page/4/Picture/0 description: The image shows the logo for American Medical Systems. The logo consists of a stylized graphic to the left of the text. The text "American Medical Systems" is in a bold, sans-serif font.

INDICATIONS FOR USE STATEMENT

(Pending) 510(k) Number:

InteMesh™ Silicone-Coated Sling and Surgical Mesh Device Name: with Inhibizone™

Indications for Use:

The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ The AMS Intellest -- Sillconc-Oouted only and Stinary incontinence resulting is an ifriplant that is intended for the troundation to reinforce soft tissues from themial hypermobility of 102 ailed on gastroenterological or gastroenterological where weakless exists in the drological gynoseres
anatomy. This includes, but is not limited to pubourethral support and bladder support.

Prescription Use
(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)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number K642592

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.