(67 days)
The Island Biosurgical, Inc. Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.
A surgical kit including disposable surgical suture carriers and catheter stylet, implantable polypropylene mesh bolsters, a urethral Malecot catheter, surgical drapes, with bone anchors (Kit #2) or without bone anchors (Kit #1).
This document is a 510(k) Summary for the Island Biosurgical Bladder Neck Suspension Kit from 1997. It explicitly states:
"Performance testing: Performance testing was not included in this 510 (k)."
Therefore, based on the provided text, the device did not undergo performance testing to establish acceptance criteria or to prove that the device meets such criteria. Consequently, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth can be extracted from this document.
§ 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.