(51 days)
The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.
The AdVance XP Male Sling System is provided as a sterile, single-pack kit composed of the following primary components: Male Sling, Needle Passers (2), Retractor Ring, and Stay Hooks. The subject of this premarket notification is around the Male Sling component of the AdVance XP Male Sling System, specifically the implantable portion of the Male Sling assembly, which is the mesh sling and the tissue anchors. There are no modifications to the Needle Passers, or Retractor Ring and Stay Hooks (which form the Retraction System) as a part of this submission. Note that the Retraction System are comprised of purchased, off-the-shelf components cleared through K791665.
The provided text is a 510(k) summary for a medical device (AdVance™ XP Male Sling System) and does not describe a study involving acceptance criteria related to software or AI performance, nor does it include information about a test set, ground truth, expert adjudication, or MRMC studies.
The document discusses the substantial equivalence of a newly proposed medical device to a predicate device, focusing on material composition, manufacturing wash processes, sterilization, and biocompatibility. The "Performance Data" section specifically mentions "bench testing" to evaluate physical attributes of the mesh and the final product assembly.
Therefore, I cannot extract the information required by your request from the provided text, as it pertains to a different type of medical device evaluation.
§ 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.