The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

Device Description

The Monarc and BioArc TO Subfascial Hammocks are suburethral sling procedure that rne Moharo and Blor .. orgical approach to treat stress urinary incontinence. They are uses a transoblarator ourgrout approcessions of two stainless steel curved needle passers and a mesh or mesh and graft sling assembly.

AI/ML Overview

The provided text is a 510(k) summary for the Monarc and BioArc TO Subfascial Hammocks. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not present in this document.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative measures like sensitivity, specificity, or minimum clinical improvement. The primary acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is a qualitative assessment based on intended use, technological characteristics, and performance.
Reported Device Performance: The document states:
- "The Indications for Use, fundamental scientific technology, surgical approach, sling placement, and materials are all the same as the predicates."
- "The risk analysis and validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy."
- "The Monarc and BioArc TO + and C Subfascial Hammock versions are substantially equivalent to their predicates with respect to intended use, technological characteristics, and performance."

Since this is a substantial equivalence claim, there are no specific performance metrics like sensitivity or specificity reported for the Monarc and BioArc TO devices themselves in comparison to specific quantitative thresholds. The "performance" assessment here refers to the device behaving similarly to the predicate devices and not introducing new safety or efficacy concerns.

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

Not Applicable/Not Provided: The document does not describe a test set or a study that uses a specific sample size of patients or images to evaluate the performance of the Monarc and BioArc TO devices. The submission relies on demonstrating equivalence to predicate devices, which would have undergone their own validation. The term "validation activities" is mentioned, but no details regarding sample size or provenance are provided for these activities.

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

Not Applicable/Not Provided: There is no mention of a test set, experts, or ground truth establishment in the context of a new study for the Monarc and BioArc TO devices.

4. Adjudication Method for the Test Set:

Not Applicable/Not Provided: As no specific test set is detailed, no adjudication method is mentioned.

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 device is a surgical mesh for stress urinary incontinence, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.

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

Not Applicable: This is a physical medical device (surgical mesh), not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not Applicable/Not Provided: Due to the nature of a 510(k) submission for a physical device, and the lack of a new clinical study detailed in this document, no specific "ground truth" (like pathology or outcomes data) for a new test set is described. The "ground truth" in a 510(k) for a device like this often relates to established safety and performance of the predicate devices.

8. The Sample Size for the Training Set:

Not Applicable/Not Provided: This device is not an AI algorithm that would typically have a "training set."

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

Not Applicable/Not Provided: As above, this concept doesn't apply to this type of device and submission.

Summary of Approach in this 510(k) Document:

This 510(k) submission (K051530) for the Monarc and BioArc TO devices follows a substantial equivalence pathway. It relies on demonstrating that the new devices are essentially the same as already legally marketed predicate devices (Monarc Subfascial Hammock, K023516, and BioArc TO Subfascial Hammock, K040538). The "study" (referred to as "validation activities") is presented as substantiating this equivalence, implying that no new, extensive clinical trials with specific performance metrics were required or conducted for this submission. The focus is on showing that the new devices share the same intended use, technological characteristics, surgical approach, sling placement, and materials as the predicates, thereby not raising new safety or efficacy questions.

Summary

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K051530

JUL - 8 2005

2.6	510(k) Summary	1/2
Submitter:	American Medical Systems10700 Bren Road WestMinnetonka, MN 55343Phone: 952-933-4666Fax: 952-930-6496
Contact Person:	Denise Thompson
Date Summary Prepared:	June 8, 2005
Device Common Name:	Urethral Sling, Surgical Mesh
Device Trade Name:	MonarcTM, MonarcTM +, and MonarcTM CSubfascial Hammocks / BioArc TOTM,BioArcTM TO +, and BioArc TO - CSubfascial Hammocks
Device Classification Name:	Surgical Mesh, polymeric
Predicate Device:	MonarcTM Subfascial Hammock, K023516BioArcTM TO Subfascial Hammock, K040538

Device Description:

Device Desoription...
The Monarc and BioArc TO Subfascial Hammocks are suburethral sling procedure that rne Moharo and Blor .. orgical approach to treat stress urinary incontinence. They are uses a transoblarator ourgrout approcessions of two stainless steel curved needle passers and a mesh or mesh and graft sling assembly.

Indications for Use:

Indications for Ooo.
The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of I he Monaro and arra and of female stress urinary incontinence (SUI) a ouburothral hypermobility and / or intrinsic sphincter deficiency.

Comparison to Predicate Device:

Companson to Freditore Donoot.
The Monarc and BioArc TO + and C needle passers offer physicians alternative needle The Monaro and Dio. 16 To To The needle passers are all designed for a transobturator approach.

The Indications for Use, fundamental scientific technology, surgical approach, sling placement, and materials are all the same as the predicates.

Supporting Information:

Supporting Informlation / validation activities reported in this Special The hisk andication substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy.

DMC
7/8/05

Page 25 of 30

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K051530

Conclusion:

The Monarc and BioArc TO + and C Subfascial Hammock versions are substantially equivalent to their predicates with respect to intended use, technological characteristics, and performance.

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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 a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is simple and recognizable, conveying the department's authority and commitment to public service.

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

SEP 2 8 2012

Ms. Denise Thompson Regulatory Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

Re: K051530

Trade/Device Name: Monarc +, and Moncarc C Subfascial Hammocks and the BioArc TO, BioArc To +, and BioArc TO-C Subfascial Hammocks

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: June 8, 2005 Received: June 9, 2005

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of July 8, 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 (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/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,

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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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

INDICATIONS FOR USE STATEMENT 1.4

510(k) Number (if known):

Device Name: AMS Monarc +, and Monarc C Subfascial Hammocks and : AMS Monarc, Monarc +, and Monaro & Cubrial +
the BioArc TO, BioArc TO +, and BioArc TO - C Subfascial Hammocks

Indications For Use:

The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of
Children TO Subfascial Art of Supela strace urinery incontinence (SUI) The Monarc and BloAte TO Sublastian Hamouth of Semale Stress urinary incontinence (SUI)
a suburethral sling for the treatment of female stress urington deficiency a suburethral sling for the treathent of lomals of lomals strency.
resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

× 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)

Stypt. Rurder

(Division Division of General, Restorative. and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Page 12 of 30

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.