(133 days)
ETHICON PHYSIOMESH™ Open may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device is a sterile, partially absorbable skirted mesh device designed for the repair of hernias and other fascial defects. The implant device is composed of a macroporous mesh, knitted from polypropylene and polydioxanone fibers, laminated to an absorbable poliglecaprone 25 film that is intended to physically separate the mesh from underlying tissue and organ surfaces thereby reducing unintended tissue attachment to the mesh. The perimeter edges are prefolded to create the fixation skirt that facilitates manual placement and positioning against the intra-abdominal wall, while allowing for the use of mechanical fixation devices.
The provided text describes the 510(k) premarket notification for the "ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device". However, this document pertains to a medical device (surgical mesh) and does not include information about a software AI/ML device.
Therefore, I cannot extract any information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device from this document. The document primarily focuses on the physical and biological characteristics of the surgical mesh, its intended use, and its substantial equivalence to predicate devices based on bench and animal testing.
There is no information in the provided text to answer any of the requested points regarding an AI/ML device 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.