(130 days)
Versatex™ Monofilament Mesh is intended for soft tissue reinforcement where weakness exists.
Versatex™ monofilament mesh is intended for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Versatex™ Monofilament Mesh is made out of a macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.
The document is a 510(k) summary for the Versatex™ Monofilament Mesh, a surgical mesh product. The provided text outlines the device's characteristics and its equivalence to predicate devices, but does not describe acceptance criteria for a device-under-test compared to reported performance from a study nor does it outline a study to prove acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating performance of the device against such criteria based on the provided text. The document refers to "bench testing" but does not provide results, sample sizes, ground truth information, or detail comparative effectiveness studies in the form requested.
It mentions that "Bench testing has been conducted... to evaluate the performance characteristics of the Versatex™ Monofilament Mesh" and that "The bench results demonstrate that the device is substantially equivalent to the primary predicate Mersilene™ Polyester Fiber Mesh." However, no specific performance data or acceptance criteria are presented in the text.
The information provided relates to the regulatory submission process for a medical device rather than a detailed performance study.
§ 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.