(181 days)
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 incorporatescontinuous, 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.
The provided text describes a 510(k) premarket notification for the T-Line Hernia Mesh and does not include information about an AI/ML powered medical device. Therefore, I cannot answer the questions about acceptance criteria, study details, expert qualifications, or comparative effectiveness as these are not relevant to the provided content.
The document discusses the substantial equivalence of the T-Line Hernia Mesh to a predicate device, focusing on an expansion in its Indications for Use to include an open sublay approach. It details performance testing conducted on an animal model to support this expanded indication for use.
§ 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.