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The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The proposed device is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body with polypropylene carriers, each are attached to separate ends.

This document describes a 510(k) premarket notification for a Surgical Mesh (SIS), seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving that a device meets specific performance metrics in the way a diagnostic AI device submission would.

Instead, this submission establishes substantial equivalence based on:

• Intended Use: The proposed device has the same intended use as the predicate devices: "a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency."
• Technological Characteristics: The proposed device has "the same and/or equivalent technological characteristics (i.e. mesh design and mesh material)" as the predicate(s).
• Performance Characteristics: The submission states that "performance characteristics tested" demonstrated substantial equivalence. However, the details of these performance characteristics or the specific tests conducted are not provided in this excerpt.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided 510(k) summary.

In summary, the provided document is a regulatory filing asserting substantial equivalence based on intended use, technological characteristics, and general performance, rather than a detailed study report with specific acceptance criteria and outcome data for a new, novel AI device or a device with new performance claims.

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