(61 days)
AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.
The provided text describes a 510(k) summary for the "PFR Sling System, Part of the AMS Pelvic Floor Repair System," which is a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a device output.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.
The document states:
- "The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." (Page 1, under "Summary of Testing")
This indicates that a comparison was made against existing, legally marketed devices. However, the details of what "performance requirements" were and how "substantial equivalence" was demonstrated in terms of specific metrics, acceptance criteria, or a detailed study are not included in this summary.
In summary, the provided document does not contain the information necessary to fulfill the request as it describes a regulatory submission based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and device performance metrics.
§ 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.