(333 days)
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated in sterile saline prior to use. The thickness of the device is 1.5 to 2.3mm. The XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline at 180 µg/cm each. The coating is shaded orange in color due to the color of the antimicrobial agents. The bioresorbable L - Tyrosine succinate polymer is essentially absorbed in 12 months based on in vitro studies. The antimicrobial coating present on this device is intended to protect the graft from bacterial colonization.
The provided text describes the XenMatrix™ AB Surgical Graft, a surgical mesh, and its comparison to predicate devices for 510(k) clearance. However, the document does not describe an AI/ML-driven device, nor does it contain information about acceptance criteria and a study proving an AI device meets those criteria.
Instead, the document details the safety and effectiveness summary for a physical medical device (a surgical graft) based on biocompatibility testing, bench testing, in vivo strength determinations, drug content analysis, and animal testing.
Therefore, I cannot fulfill your request for an AI device's acceptance criteria and study information using the provided text. The information requested (multi-reader multi-case study, effect size of human readers with AI, standalone performance, training set details, ground truth establishment methods for training/test sets, expert qualifications) is specific to AI/ML device approval and is not present in this document.
§ 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.