(90 days)
The XenMatrix™ AB Surgical Graft is 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, 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 reduction 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 proposed 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. The coating is shaded orange in color due to the color of the antimicrobial agents.
The provided document describes the XenMatrix™ AB Surgical Graft, a collagen surgical mesh containing drugs, which is intended for implantation to reinforce soft tissue. However, it does not contain information about acceptance criteria, the specific study that proves the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes for an AI/CADe device.
The document is a 510(k) summary for a medical device (surgical mesh) that references preclinical in vitro and in vivo testing to support the claim of reduced microbial colonization. It explicitly states that "The claim of reduction 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." This indicates the absence of human clinical trials for this specific claim.
Therefore, I cannot fulfill your request for information related to acceptance criteria, specific study details as you've outlined, or AI/CADe performance metrics, as these are not present in the provided text. The document focuses on regulatory approval (510(k)) based on substantial equivalence to a predicate device and preclinical data.
§ 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.