(375 days)
The XTAC is indicated for the temporary bridging of fascial defects where primary closure is not possible, including, but not limited to, abdominal compartment syndrome.
Not Found
This document is a 510(k) clearance letter from the FDA for a surgical mesh device, XTAC™. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria, as one would find for an AI/ML powered medical device.
The letter states that the device is substantially equivalent to legally marketed predicate devices, which means it has been found to be as safe and effective as a device already on the market. For this type of device (surgical mesh), substantial equivalence is typically demonstrated through a comparison of technological characteristics, materials, and intended use with the predicate device, rather than through performance metrics like sensitivity, specificity, or F1-score which are relevant for AI/ML devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as this document pertains to a traditional medical device clearance and not an AI/ML 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.