The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The Align™ Urethral Support System includes a sterile, single use permanent implant that provides strong, stable support for the urethra in patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip. The open porosity of the mesh design and large pore sizes allows for macrophage penetration and tissue ingrowth to promote the creation of a permanent support for the urethra. The knitted polypropylene mesh is made from a small fiber diameter which creates a soft and pliable material.

Several configurations of this device will be offered, including retropubic, suprapubic, and transobturator, which are used to implant the device.

The principles of operation and fundamental scientific technology have not changed from the predicate.

AI/ML Overview

The provided text describes a 510(k) summary for the "Bard Align™ Urethral Support System," a surgical mesh used for treating female stress urinary incontinence. However, this document does not contain the kind of detailed performance study information that would allow me to answer your specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or AI-related metrics.

The document states:

"The appropriate testing, including guidance testing, to determine substantial equivalence of the Align™ Urethral Support System was conducted."
It mentions "PERFORMANCE DATA SUMMARY" but then provides no actual performance data or details about specific studies conducted. Instead, it moves directly to regulatory correspondence.

Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets acceptance criteria in the way medical device AI submissions typically do.

Here's what I can extract, even though it doesn't directly answer your specific questions related to performance criteria:

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

This information is not present in the provided document. The document states that "appropriate testing... to determine substantial equivalence... was conducted," but it does not report the acceptance criteria or the specific performance metrics achieved by the device.

2. Sample sized 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.

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

This information is not present in the provided document.

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 device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and not mentioned.

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

This device is a surgical mesh, not an algorithm. Therefore, standalone algorithm performance is not applicable and not mentioned.

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

This information is not present in the provided document.

8. The sample size for the training set:

This information is not present in the provided document. This device is a surgical mesh, not a machine learning model, so the concept of a "training set" in this context is not applicable.

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

This information is not present in the provided document.

In summary, the provided document is a 510(k) summary for a traditional medical device (surgical mesh) and does not contain the detailed performance study information typically required for AI/ML-based medical devices, which is what your questions are designed to elicit.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

SUBMITTER INFORMATION: A.

Submitter's Name:	C. R. Bard, Inc.Bard Urological Division
Address:	13183 Harland Dr.Covington, GA 30014
Contact Person:	Julie J. Bassett
Contact Person's Telephone Number:	678-342-4921
Contact Person's Fax:	770-788-5517
Date of Preparation:	March 9, 2006

B. DEVICE NAME:

Trade Name(s):	Bard Align™ Urethral Support System
Common/Usual Name:	Urethral Sling; Surgical Mesh
Classification Names:	79 OTN-Mesh, Surgical, Polymeric; CFR Reference:21 CFR 878.3300, Surgical mesh

PREDICATE DEVICE NAME: C.
- Uretex® TO Trans-Obturator Urethral Support System Trade Name(s):
D. Device Description:

Several configurations of this device will be offered, including retropubic, suprapubic, and transobturator, which are used to implant the device.

The principles of operation and fundamental scientific technology have not changed from the predicate.

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E. Intended Use:

The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The intended use has not changed from the predicate (K041176).

TECHNOLOGICAL CHARACTERISTICS SUMMARY: F.

The subject device, the Align™ Urethral Support System, has the same intended use, general design and fundamental scientific technology as the predicate device (K041176).

G. PERFORMANCE DATA SUMMARY:

The appropriate testing, including guidance testing, to determine substantial equivalence of the Align™ Urethral Support System was conducted.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

SEP 2 8 2012

C.R. Bard, Inc. % Ms. Julie J. Bassett. RAC Regulatory Affairs Specialist 13183 Harland Drive COVINGTON GA 30014

Re: K070073 Trade/Device Name: Align™ Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 5, 2007 Received: January 8, 2007

Dear Ms. Bassett:

This letter corrects our substantially equivalent letter of March 21, 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/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,

Benjamin R. Fuchs

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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C.R. Bard, Inc., Bard Urological Division Align™ Urethral Support System Premarket Notification {510(k)]

1.3 Indications for Use Statement

510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence 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)

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

(Recommended Format 11/13/2003)

(Division Sign-Off) Division of General, Restorative, and Neurological Device

510(k) Number L070073

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.