The RetroArc™ Retropubic Sling System is 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 (ISD).

Device Description

The RetroArc System is a sterile, single use system, consisting of one plastic handle, two stainless steel delivery needles and a sling assembly. The tip portion of each delivery needle is configured to allow for passage through tissue. The opposite end of the needle is configured to connect with the plastic handle. The handle is detachable and is used to direct both delivery needles through tissue. The sling assembly includes one piece of loosely knitted polypropylene mesh with an integrated adjustment suture, two removable plastic insertion sheaths, and two connectors attached to the insertion sheaths. The adjustment suture is an integral feature woven into the mesh which limits the overall stretch of the mesh arms during the procedure. The integrated suture and mesh, allow for adjustment of the sling after initial placement in the patient without the use of additional tools. The two plastic sheaths overlap during placement and allow for convenient travel of the sling through the tissue. The connectors, sheaths, and delivery instruments are used to facilitate placement of the mesh assembly, and are not implanted. The mesh component is not absorbed by the action of tissue in-growth or tissue enzymes

AI/ML Overview

Here's an analysis of the provided information regarding the RetroArc™ Retropubic Sling System, focusing on acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Material/Processing	Sterilization	Successfully completed
	Shelf Life	Successfully completed
	Biocompatibility	Successfully completed
Delivery Instrument	Delivery Instrument Torsional Strength	Successfully completed (meets product specification and performance requirements)
	Needle Connection Cycling	Successfully completed (meets product specification and performance requirements)
	Needle Connection Push Force	Successfully completed (meets product specification and performance requirements)
	Needle Disconnection Pull Force	Successfully completed (meets product specification and performance requirements)
	Needle Disconnection Button Force	Successfully completed (meets product specification and performance requirements)
Human Factors/Usability	Physician Questionnaire (cadaver evaluation)	Successfully completed
	Cadaver Evaluation	Successfully completed
	Cadaver Dissection	Successfully completed
Effectiveness (Clinical)	Treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD)	Not directly assessed through clinical trials for this device; reliance on substantial equivalence to predicate.

Study Details

This submission does not describe a study to prove the device meets specific acceptance criteria in terms of clinical efficacy or diagnostic accuracy for an AI/CADe device. Instead, it describes non-clinical testing to demonstrate the substantial equivalence of a medical device (a surgical sling system) to a predicate device.

Here's the breakdown based on the request, adapted for the provided information:

A table of acceptance criteria and the reported device performance:
(See table above)
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set (for non-clinical performance and cadaver studies): The document does not specify exact sample sizes for the bench tests (e.g., how many instruments were tested for torsional strength). For the cadaver studies, the sample size is also not explicitly stated (e.g., "Physician Questionnaire," "Cadaver Evaluation," "Cadaver Dissection" imply a limited number of cadavers and physicians, but no numbers are provided).
- Data Provenance: Not specified beyond being "bench testing" and "cadaver testing." No country of origin is mentioned. These are non-clinical studies.
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):
- For Bench Testing: "Bench testing was performed to support this submission." The experts here would be the engineers/technicians performing the tests and comparing results to product specifications. Their number and qualifications are not provided.
- For Cadaver Testing: "Physician Questionnaire," "Cadaver Evaluation," "Cadaver Dissection." These imply physician involvement. The number of physicians and their qualifications are not provided. They would be establishing a "ground truth" on the usability and handling of the device in a cadaveric setting, not a clinical outcome.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is described. The non-clinical tests likely followed standard engineering validation protocols. The cadaver evaluation seems to involve direct assessment, but no multi-reader/adjudication process is mentioned.
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:
- No MRMC study was done. This document is for a surgical sling system, not an AI/CADe device. Therefore, the concept of human readers improving with AI assistance is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm only) performance study was done. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Bench Testing: The ground truth is based on predefined product specifications and engineering requirements.
- For Cadaver Testing: The ground truth seems to be an assessment of device handling, placement, and anatomical interaction by physicians in a simulated environment (cadavers). This would be a form of expert assessment of physical performance, not clinical outcomes.
The sample size for the training set:
- Not applicable. This device is a physical surgical implant and delivery system, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This device does not use a training set as it is not an AI model.

Conclusion:

The K132655 submission for the RetroArc™ Retropubic Sling System does not involve AI or CADe technology. Therefore, many of the requested details regarding AI-specific studies (MRMC, standalone performance, training sets, ground truth for AI models) are not applicable.

The submission focuses on establishing substantial equivalence to a predicate device (SPARC® Sling System K081613) through non-clinical bench testing and cadaver studies. The acceptance criteria are primarily related to the mechanical performance of the delivery instruments and the usability in a cadaveric setting, demonstrating that the design modifications (primarily to the delivery instruments) do not negatively impact the fundamental performance or safety compared to the predicate device. No clinical testing was performed for this submission. The "ground truth" for the non-clinical tests was established by meeting engineering specifications and by qualitative assessment during cadaveric evaluation.

Summary

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510(k) Summary As required by 21CFR 807.92(c)

510(k) Number: _ K132655_

Date Prepared:Submitter Information:	August 23, 2013
Submitter's Name/Address:	American Medical Systems10700 Bren Road W.Minnetonka. MN 55343
Contact Person:	Renee MellumSr. Regulatory Affairs SpecialistTel: 952-930-6458Fax: 952-930-5785Renee.Mellum@AmericanMedicalSystems.com
Alternate Contact:	Melanie HessDirector, Regulatory AffairsTel: 952-939-6490Fax: 952-930-5785Melanie.Hess@AmericanMedicalSystems.com

Device Information:

RetroArc" Retropubic Sling System
Surgical Mesh
21 CFR § 878.3300
OTN

Predicate Device:

SPARC® Sling System (K081613)

Device Description:

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510(k) Summary As required by 21CFR 807.92(c)

mesh which limits the overall stretch of the mesh arms during the procedure. The integrated suture and mesh, allow for adjustment of the sling after initial placement in the patient without the use of additional tools. The two plastic sheaths overlap during placement and allow for convenient travel of the sling through the tissue. The connectors, sheaths, and delivery instruments are used to facilitate placement of the mesh assembly, and are not implanted. The mesh component is not absorbed by the action of tissue in-growth or tissue enzymes

Indications for Use:

The RetroArc Retropubic Sling System is 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 (ISD).

Comparison to the Predicate Device:

The fundamental scientific technology on the RetroArc" Retropubic Sling System is unchanged from the predicate device. The intended use and indication for use is identical to that of the predicate device. In addition, the RetroArc System utilizes the same sling assembly, utilizing the identical implant materials and design principles as the predicate SPARC Sling System (K081613). The primary change to the device is the delivery instruments to allow for placement of the sling using a retropubic approach. The changes to the delivery needle include a longer length, an increased needle angle, and larger needle diameter. The plastic handle was also modified to allow for detachment of the delivery needle after placement. This allows one handle to be used to direct both delivery needles through tissue.

Summary of Non-Clinical Testing:

Bench testing was performed to support this submission. Results of the testing demonstrate that the RetroArc Retropubic Sling System meets product specification and performance requirements.

The following testing has been successfully completed:

. Sterilization
Shelf Life ●
Biocompatibility .
Performance Testing (Bench) .
- Delivery Instrument Torsional Strength 0

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510(k) Summary As required by 21CFR 807.92(c)

Needle Connection Cycling 0
Needle Connection Push Force O
Needle Disconnection Pull Force 0
Needle Disconnection Button Force 0
. Performance Testing (Cadaver)
- Physician Questionnaire 0
- Cadaver Evaluation o
- Cadaver Dissection O

Clinical Testing:

No clinical testing was performed to support this Traditional 510(k) Premarket Application.

Statement of Equivalence:

The RetroArc Retropubic Sling System has the identical indications for use and fundamental scientific technology as the predicate device. Based on this and the design and engineering data provided in the pre-market notification, the RetroArc Retropubic Sling System has been shown to be substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 20, 2013

American Medical Systems, Inc. Renee Mellum Sr. Regulatory Affairs Specialist 10700 Bren Road West Minnetonka, MN 55343

Re: K132655

Trade/Device Name: RetroArc™ Retropubic Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 23, 2013 Received: August 26, 2013

Dear Renee Mellum,

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - Renee Mellum

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ucm 1 15809.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" (21CFR 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.goy/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 -S

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

K132655 510(k) Number: __

Device Name: RetroArc'" Retropubic Sling System

Indications for Use:

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)

Benjamin R. Fisher -S 2013.11.20 16:52:15 -05'00'

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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.