The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Device Description

The Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System. The available information primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as a such a study (with specific performance metrics, ground truth, and reader studies) appears not to have been conducted or detailed in this 510(k) summary. The submission relies on comparative analysis and bench testing.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What they aimed to achieve)	Reported Device Performance (How it met the criteria)
Design Equivalence to Predicate Device: The device's design should be substantially equivalent to the American Medical Systems (AMS) AdVance Male Sling System.	The Coloplast VIRTUE™ system is stated to be "substantially equivalent in design" to the predicate device.
Material Equivalence to Predicate Device: The device's materials should be substantially equivalent to the AMS AdVance Male Sling System.	The Coloplast VIRTUE™ system is stated to be "substantially equivalent in... materials" to the predicate device. The device consists of polypropylene mesh.
Performance Characteristics Equivalence to Predicate Device: The device's performance characteristics should be substantially equivalent to the AMS AdVance Male Sling System.	The Coloplast VIRTUE™ system is stated to be "substantially equivalent in... performance characteristics" to the predicate device. This was supported by "bench testing compared to the predicate device."
Indications for Use Equivalence to Predicate Device: The indications for use should be substantially equivalent to the AMS AdVance Male Sling System.	The Coloplast VIRTUE™ system is stated to be "substantially equivalent in... indications" to the predicate device: "an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI)."
Biocompatibility: The device should be biocompatible.	"Biocompatibility testing performed on the subject device" supported substantial equivalence. Specific acceptance criteria or results are not provided.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give details on the number of samples or specific test cases.
Data Provenance: Not specified. Given it's bench testing, it would likely be laboratory-generated data rather than patient data.

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

This information is not available in the provided document. The study described is bench testing and comparative analysis, not a clinical study involving experts establishing ground truth for performance metrics in a patient context.

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

This information is not applicable and not available. Adjudication methods are typically used in clinical studies or reader studies where multiple experts assess cases. The described testing is bench testing.

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

No, an MRMC comparative effectiveness study was not done. The device is a surgical sling system, not an AI or diagnostic imaging device.

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

Not applicable. The device is a physical surgical implant, not an algorithm.

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

For the bench testing, the "ground truth" would be objective measurements of physical properties (e.g., tensile strength, elasticity, pore size) and material properties that are compared against predefined specifications or the predicate device's characteristics. The document implies comparison to the predicate device's known characteristics as the "truth" for equivalence.

8. The sample size for the training set

Not applicable / Not available. The device is a physical product, not an AI algorithm that requires a training set. The "testing" involved bench testing, not machine learning model training.

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

Not applicable / Not available. (See point 8).

In summary: The 510(k) summary focuses on demonstrating "substantial equivalence" of the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System to a legally marketed predicate device (AMS AdVance Male Sling System) through a comparison of design, materials, performance characteristics (via bench testing), and indications for use. It does not contain details of a clinical study with quantifiable acceptance criteria for diagnostic accuracy, reader performance, or patient outcomes that would typically involve experts, ground truth, or specific sample sizes in the manner implied by the questions.

Summary

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K08 2640
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5 510(k) Summary

510(K) Owner's Name:	Coloplast A/S	OCT 17 2008
Address:	Holtedam 13050 Humlebaek, DenmarkEstablishment Registration: 9610694Owner/Operator: 8010144
Name Of Contact Person:	Angela BylandRegulatory Affairs Manager
Phone And Fax Numbers:	Phone: (612) 287-4236Fax: (612) 287-4138Email: usaby@coloplast.com
Submission Date:	September 9, 2008
Trade Name:	VIRTUE™ Ventral Urethral Elevation Sling System
Common or Usual Name:	Sub-Urethral Sling System; Surgical Mesh
Classification Name:	Surgical Mesh, polymeric

Legally Marketed Device To Which Your Firm Is Claiming Equivalence:

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is substantially equivalent in performance, indications, design and materials to American Medical Systems (AMS) AdVance Male Sling System cleared under premarket notification number K053371.

Description Of The Device:

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K082640
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Intended Use Of The Device:

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Technological Characteristics Compared To Predicate Device:

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is substantially equivalent in design, materials, performance characteristics, and indications to the predicate American Medical Systems (AMS) AdVance Male Sling System cleared under premarket notification number K053371.

Summary and Conclusions of The Nonclinical Tests Submitted:

Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2008

Coloplast Corporation % Ms. Angela Byland Manager, Regulatory Affairs 1499 West River Road North Minneapolis, Minnesota 55411

Re: K082640

Trade/Device Name: VIRTUE Ventral Urethral Elevation Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 13, 2008 Received: October 14, 2008

Dear Ms. Byland:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Angela Byland

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

Indications for Use

K082640 510(k) Number (if known): Device Name: VIRTU E Ventral Indications for Use:

The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yurke Dyle for man

and Neu cal Device

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(Posted November 13, 200

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.