(114 days)
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.
§ 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.