(30 days)
ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.
The provided text, K082216, is a 510(k) premarket notification for a medical device (ETHICON Mesh) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven devices or diagnostics.
Instead, this submission focuses on establishing substantial equivalence to previously marketed predicate devices for a surgical mesh. The "Performance Data" section is brief and refers to material biocompatibility and functional requirements, not clinical or diagnostic performance criteria as one would find for an AI algorithm.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth information, expert details, or MRMC study results because this document does not contain that type of information.
The relevant information from the document related to "performance" is:
- Performance Data Mentioned: "Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements."
- Conclusion Basis: Substantial equivalence to predicate devices (GYNECARE GYNEMESH® PS PROLENE® Soft Mesh and GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems) based on similar technological characteristics.
This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through material characterization, mechanical testing, and comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical endpoints that would be required for a novel device or a device making diagnostic claims.
§ 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.