(52 days)
The Single Incision Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The AMS Single Incision Sling System is a modification of Monarc consisting of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.
The provided text does not contain information about acceptance criteria, device performance metrics, or details of a study with sample sizes, expert involvement, or ground truth establishment.
The document is a 510(k) summary statement for the AMS Single Incision Sling System, primarily discussing its device description, indications for use, and its substantial equivalence to a predicate device. It also includes an FDA letter confirming the 510(k) clearance.
Therefore, I cannot fulfill your request for the tables and study details based on the provided input.
§ 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.