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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically . retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision.
• . Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

• . Scal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site. ●
• Access the thoracic cavity or other soft tissue retraction during cardiac and . general surgical procedures through an atraumatically-retracted incision.

The Coloplast Virtue Male 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. The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large. The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box.

The Coloplast Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K111881) is not an AI/ML device. It is a surgical mesh system and wound retractor. The provided text describes the device's technical characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating device performance relative to such criteria that would typically be associated with AI/ML systems.

The 510(k) summary explicitly states:

• "Summary Of Clinical Tests Submitted (As Applicable): Not applicable"
• "The Virtue System and Alexis Retractor devices have been subjected to biocompatibility and mechanical testing and were found substantially equivalent to the predicates per 510ks K101297 and K041711; thus, no additional biocompatibility or mechanical testing was conducted to support this Special 510(k)."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to AI/ML performance, as these concepts are not relevant to this specific device and are not discussed in the provided regulatory submission.

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