The Smart Sling System is 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 AMS Smart Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.

AI/ML Overview

This document describes the AMS Smart Sling System, a surgical mesh device intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI). The provided text is a 510(k) summary statement and a subsequent FDA letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than reporting on specific acceptance criteria and a detailed study proving the device meets those criteria.

Therefore, much of the requested information cannot be definitively extracted from the provided text. The document does not contain specific acceptance criteria with numerical targets for device performance or a detailed study report demonstrating the device meets such criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The submission focuses on substantial equivalence, which implies the device performs comparably to legally marketed predicate devices, but it does not specify explicit performance metrics or acceptance criteria for the AMS Smart Sling System itself.

2. 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 present in the provided document. The document mentions "bench and biocompatibility testing, cadaver studies and a literature review" as supporting information. However, no details about sample sizes, data provenance (country, retrospective/prospective nature), or specific study designs are provided.

3. 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 present in the provided document. Since specific clinical studies with a "test set" and "ground truth" are not detailed, there's no mention of experts or their qualifications in this context. The "cadaver studies" might involve expert assessment, but no details are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

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

This information is not present in the provided document. The AMS Smart Sling System is a surgical mesh device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not applicable to this device.

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

This information is not present in the provided document. As mentioned, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided document. While the device's efficacy would ultimately be measured by patient outcomes (reduction in SUI symptoms), the provided submission focuses on pre-market clearance based on substantial equivalence, not on detailed clinical trial results with established ground truth types for a specific test set.

8. The sample size for the training set

This information is not present in the provided document. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this device.

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

This information is not present in the provided document. As above, the concept of a "training set" and its ground truth is not applicable.

Summary of available information related to "study" and "evidence":

The supporting information mentioned for the substantial equivalency determination includes:

Previously cleared and new bench and biocompatibility testing: This refers to laboratory tests on the material and mechanical properties of the sling and its components, as well as tests to ensure it's safe for use in the body. No specific results, sample sizes, or acceptance criteria for these tests are provided.
Cadaver studies: These studies would involve the use of human cadavers to evaluate the surgical technique and placement of the sling. No details on the number of cadavers, the specific protocol, or findings are given.
A literature review: This would involve reviewing existing scientific publications related to similar surgical meshes and procedures. This supports the general understanding and safety profile but is not a direct study on the specific device's performance.

In conclusion, the provided FDA document is a 510(k) summary that emphasizes substantial equivalence to predicate devices through various forms of non-clinical testing and literature review. It does not present a detailed study with explicit acceptance criteria and corresponding performance data that directly answers the specific questions about typical clinical study parameters.

Summary

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ડ. 510(k) Summary Statement

FEB 2 2 2007

Submitter:	American Medical Systems (AMS)10070 Bren Road WestMinnetonka, MN 55343Phone: 952.933.6139FAX: 952.930.5785
Contact Person:	Brad Onstad
Device Common Name:	Sub-Urethral Sling System; Surgical Mesh
Device Trade Name:	AMS Smart Sling System
Device Classification Name:	Surgical Mesh, polymeric (OTN)
Predicate Devices:	Caldera "T" Sling (K050516),MonarcTM Subfascial Hammock (K023516),SparcTM Sling System (K011251)

Device Description

Indications for Use

Comparison to Predicate Devices

The AMS Smart Sling System provides physicians an alternative surgical approach to implant sub-urethral slings to treat female stress urinary incontinence. The AMS Smart Sling System material, design and characteristics are substantially equivalent to those exhibited by T-Sling, Monarc, Sparc and other surgical meshes cleared for commercial distribution. The materials, design and characteristics of the AMS Smart Sling Surgical Needle Instrument (also called "Needle Passer") used for sling placement are substantially equivalent to those embodied in the Caldera "T" Sling, Monarc Subfascial Hammock Needle Passer and Sparc Sling needles as well as other surgical instruments cleared for commercial distribution.

Supporting Information

Substantial equivalency was supported by previously cleared and new bench and biocompatibility testing, cadaver studies and a literature review.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized depiction of an eagle or bird-like figure with three swooping lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

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

Mr. Brad Onstad Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K063713 Trade/Device Name: AMS Smart Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: December 14, 2006 Received: December 14, 2006

Dear Mr. Onstad:

This letter corrects our substantially equivalent letter of February 22, 2007.

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/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

510(k) Number (if known):

Device Name: AMS Smart Sling System

Indications For Use: The Smart Sling System is 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

K663713

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

Mark A. Milliken

(Division Sign-Off) Division of General, Testorative, and Neurological De . . ces

510(k) Number

111 化663717

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.