(65 days)
Optilene Mesh LP is indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Optilene Mesh LP is a synthetic implantable sheet for the reinforcement of connective tissue structures. It consists of monofilament polypropylene, which is knitted into a dimensionally stable, thin, and flexible net that is cut into various sizes and shapes.
The provided document is a 510(k) summary for the Optilene Mesh LP surgical mesh. It declares substantial equivalence to existing predicate devices but does not contain information about acceptance criteria, performance studies, or details regarding the development and validation of an AI-powered device.
Therefore, I cannot extract the requested information to fill in the table and answer the questions. The document describes a traditional surgical mesh, not an AI/ML device.
§ 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.