The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers (also known as insertion tools); AMS polypropylene sling mesh and suture; and two plastic sheaths that cover and protect the sling mesh during placement.

AI/ML Overview

The provided text is a 510(k) summary for the SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems, which are surgical meshes intended for the treatment of female stress urinary incontinence. This document details the device description, intended use, and a statement of technological comparison, but it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria, as typically found in clinical studies with performance endpoints.

Here's an analysis based on the provided text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., success rate of incontinence treatment, complication rates, durability of the sling). The document focuses on demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: Not provided with quantitative data. The application asserts that "the risk analysis and the verification/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." This is a qualitative statement of equivalence, not a direct report of performance against specific criteria.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not provided in the given text. The document is a regulatory submission focused on substantial equivalence rather than a detailed clinical trial report. It mentions "verification/validation activities" but does not detail their methodology or data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided. The concept of "ground truth" as it applies to expert consensus for image analysis or diagnostic accuracy studies is not relevant to this type of device submission (surgical mesh).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided. Adjudication methods are typically used in studies where multiple readers interpret data (e.g., imaging studies) and their interpretations need to be reconciled—this is not a diagnostic device.
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:
- This information is not applicable and therefore not provided. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of images, often with AI assistance. This device is a surgical implant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable and therefore not provided. This section refers to AI algorithm performance studies, which are irrelevant for a surgical mesh device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" as understood in diagnostic device validation is not applicable here. For a surgical mesh, the "truth" would be related to clinical outcomes (e.g., resolution of SUI, complication rates), which would be assessed in clinical trials. The 510(k) summary references "risk analysis and the verification/validation activities," implying product testing and potentially some level of clinical data review from predicate devices, but no specific ground truth methodology is described for this specific submission.
The sample size for the training set:
- This information is not provided. "Training set" is a term typically used in machine learning and AI development, which is not relevant to this device's regulatory submission.
How the ground truth for the training set was established:
- This information is not applicable due to the nature of the device and the submission type.

In summary, the provided 510(k) document (K041948) is a regulatory submission primarily focused on demonstrating "substantial equivalence" of the new sling systems to previously cleared predicate devices. It argues that the new devices share similar technological characteristics and intended use, and that "risk analysis and the verification/validation activities... did not raise any new questions of safety or efficacy." This type of submission relies more on comparing features and known performance of predicate devices rather than presenting new, extensive clinical study data with specific acceptance criteria and performance outcomes for the new devices. Therefore, much of the requested detailed information regarding clinical study design, sample sizes, ground truth establishment, and expert involvement is not present in this document.

Summary

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K041948

AUG 1 1 2004

Image /page/0/Picture/2 description: The image shows the logo for American Medical Systems. The logo consists of a stylized graphic to the left of the text "American Medical Systems". The graphic is made up of several parallel lines of varying lengths, arranged in a way that resembles a stylized building or structure.

510(k) Summary

Submitter:

10700 Bren Road West Minnetonka, Minnesota 55343 Date Prepared: July 19, 2004 Contact: Kristyn M. Benson Sr. Regulatory Affairs Specialist Proprietary Name: SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems Common Name: Surgical Mesh

Class II; OTN

American Medical Systems

Device Product Code & Classification:

Predicate Device:

SPARCTM Sling System (K021263) MONARC™ Sling System (K023516) BioArc SPTM Sling System (K030123) BioArc TOTM Sling System (K040538)

Device Description:

Intended Use:

The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are intended for the placement ofa pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Statement of Technological Comparison:

The risk analysis and the verification/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.

SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems Special 510(k) Notification

Page 17 of 19

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an 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 composed of three curved lines that form the head, body, and wings. The text is in all caps and is evenly spaced around the circle.

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

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

SEP 28 2012

Re: K041948 Trade/Device Name: SPARCTM, MONARCTM, BioArc SpTM, and BioArc T1OTM Sling Systems Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: July 19, 2004 Received: July 20, 2004

Dear Ms. Benson:

This letter corrects our substantially equivalent letter of August 11, 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/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/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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INDICATIONS FOR USE STATEMENT

(Pending)

K041948

SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Device Name: Sling Systems

Indications for Use:

510(k) Number:

The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are The SPARC™, MONAHO - , Bloxino of any and sling for the treatment of female Intended for the placemont one passerting from urethral hypermobility and/or intrinsic sphincter deficiency.

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)

Miriam C. Provost

al. Restorative, and Neurological Devices

510(k) Number K041948

SPARC™, MONARC™, BioArc SP1M, and BioArc TO™ Sling Systems Special 510(k) Notification

Page 8 of 19

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.