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The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sublay approach in adults (greater than 21 years of age).

The T-Line® Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using wellestablished standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line® Hernia Meshare incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.

I am sorry, but the provided text from the FDA 510(k) notification does not contain information about acceptance criteria or a study that proves the device meets those criteria, such as a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, details on ground truth establishment, or sample sizes for training and test sets.

The document is a substantial equivalence determination for a surgical mesh, not an AI-powered medical device. It focuses on demonstrating that the T-Line Hernia Mesh is substantially equivalent to previously cleared predicate devices, primarily due to a change in contract manufacturer. The performance data mentioned refers to non-clinical testing to ensure the modified mesh continues to meet functional and performance requirements, not the kind of clinical study details typically associated with AI/ML device evaluations.

Therefore, I cannot provide the requested information based on the given text.

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