(30 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 TOPAS™ System consists of needles and mesh used to repair the connective and soft tissue in the pelvic floor.
This document is a 510(k) summary statement for a surgical mesh device, not a study report for an AI/ML powered medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, or ground truth for an AI/ML model.
Specifically:
- Acceptance Criteria and Reported Device Performance: This document states that the components of the TOPAS™ System were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device." It does not list specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device itself. The equivalence is based on the predicate device, the Apogee™ System.
- Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: None of this information is relevant or present in this document because it describes the regulatory submission for a physical surgical mesh product, not an AI/ML device that requires such evaluation.
In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria, study details, or ground truth for an AI/ML medical device. It's a regulatory document for a traditional surgical mesh product.
§ 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.