AMS COLLAGEN DERMAL MATRIX by AMERICAN MEDICAL SYSTEMS, INC.

The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse.

The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Device Description

The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.

The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling.

The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall.

The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.

AI/ML Overview

The provided text describes a 510(k) summary for the AMS Collagen Dermal Matrix. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not a study proving device meeting acceptance criteria as would typically be conducted for and reported for an AI/ML device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission. The submission focuses on demonstrating equivalence to existing surgical mesh products.

However, I can extract information related to the device's intended use and the general claim of meeting "requirements" for this type of device.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent to predicate surgical meshes for indications of use.	"The AMS collagen dermal matrix and all of the pre-connected devices have been tested in accordance with the requirements of FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices."
Suitable for soft tissue reinforcement where weakness exists.	Intended for use in "reinforcing soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy."
Safe and effective for specific procedures (e.g., urethral slings, prolapse repair).	Indications for Use explicitly list these procedures.
Biocompatible (implied for decellularized porcine dermis).	Described as "decellularized porcine dermis that is lyophilized and terminally sterilized."

Explanation of "Acceptance Criteria" for a 510(k) of this nature:

For a 510(k) submission like this one (for a traditional medical device prior to the widespread use of AI/ML), "acceptance criteria" are not typically quantitative thresholds on metrics like accuracy or sensitivity. Instead, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device. This is demonstrated by showing:

Similar intended use.
Similar technological characteristics (materials, design).
Evidence that any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "testing" mentioned typically involves biocompatibility, mechanical properties, sterilization validation, and often animal studies, which are compared to known properties of the predicate devices or established standards. The text does not provide granular details of these tests or their specific outcome values.

2. Sample size used for the test set and the data provenance:

Not Applicable. This is a 510(k) for a surgical mesh, not a data-driven AI/ML device. There is no "test set" in the context of an algorithm's performance on data. The "testing" refers to benchtop, possibly animal, and material property tests to establish equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. See point 2.

4. Adjudication method for the test set:

Not Applicable. See point 2.

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:

Not Applicable. This is not an AI/ML device, and no MRMC study was mentioned or would be relevant for this type of device.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

Not Applicable. For a surgical mesh, "ground truth" relates to the performance and safety characteristics established through laboratory testing (e.g., tensile strength, biocompatibility, porosity) and potentially animal studies, compared against the known characteristics of predicate devices and general scientific principles for medical device design. It's not "ground truth" in the sense of expert-annotated data for an AI/ML model.

8. The sample size for the training set:

Not Applicable. This is a traditional medical device, not an AI/ML device. There is no "training set" in this context.

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

Not Applicable. See point 8.

Summary

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K050445

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JUN 17 2005

510(k) Summary AMS Collagen Dermal Matrix

510(k) Number

Date of Summary Preparation: February 18, 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(s):

AMS Collagen Dermal Matrix

AMS Apogee System with Pre-Connected Collagen Dermal Matrix AMS Apogee Oyetom with Pre-Connected Collagen Dermal Matrix AMS Fenger Systems TO with Pre-Connected Collagen Dermal Matrix

Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh Product Code: DTP, PAI

Classification: Class II

Manufacturing Location:

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

Predicate Devices:

For AMS Collagen Dermal Matrix : DermMatrix/InteXen - K021160 Surgisis Sling - K992159

For AMS Bioarc SP & Bioarc TO with Pre-Connected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS Bioarc TO -- K041948

For AMS Perigee System with Pre-Connected Collagen Dermal Matrix : AMS Perigee System - K040623

For AMS Apogee System with Pre-Connected Collagen Dermal Matrix : AMS Apogee System - K040537

Indications for Use:

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КОТОШИГ
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not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Device Description:

The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.

The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.

Summary of Testing

The AMS collagen dermal matrix and all of the pre-connected devices have been tested in accordance with the requirements of FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices.

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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 the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping each other. The logo is simple and clean, and it is easily recognizable.

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

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

SEP 2 8 2012

Re: K050445

Trade/Device Name: AMS Collagen Dermal Matrix, AMS Apogee System with Pre-Connected AMS Collagen Dermal Matrix, AMS Perigee System with Pre-Connected AMS Collagena Dermal Matrix, AMS BioArc™ SP Sling Kit and BioArc To Subfascial Hammock with Pre-connected AMS Collagen Dermal Matrix

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI, PAJ, OTN, PAG Dated: May 24, 2005 Received: May 25, 2005

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of June 17, 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/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" (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/ReportalProblem/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

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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КОГОЧИГ

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: AMS Collagen Dermal Matrix

Indications For Use:

The AMS collagen dermal matrix is intended for use in the treatment of The AMO onliagon connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, reinforce contineerological anatomy. This includes but is gynecological and gaol.com procedures: pubourethral support including nor limited to the following prolapse repair, colon and rectal urethnul Silings, are.narruction of the pelvic floor, bladder support, prolapse repair, sacral colposuspension and reinforcement in the repair of the Peyronie's disease. By providing pubourethral support, the AMS collagen demal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801 Subpart D)

Over-The Counter

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

( Division of General, Restorative and Neurological Devices

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5.29(c) Number KOS0445

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.