(336 days)
ARISTE AB Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The non-absorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surqical implantation.
ARISTE AB Mesh is intended for single patient one-time use only.
ARISTE AB Mesh is a non-resorbable sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The mesh is constructed of polypropylene fibers knitted together to form the mesh. The resulting structure is an implant which reinforces the tissue defect. The mesh is coated with a thiolene polymer. The coating acts as a carrier for antibiotic agents rifampin and minocycline in equal concentrations of approximately 171μg/cm² to help provide protection from bacterial colonization of the device during surgical implantation.
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically expected for an AI/ML device submission (e.g., performance metrics like sensitivity, specificity, accuracy, or AUC).
The document is a 510(k) clearance letter and summary for a surgical mesh (ARISTE AB Mesh), which is a physical medical device, not an AI/ML software device. The "performance testing" described refers to bench, animal, and biocompatibility testing for a physical implant, and the "acceptance criteria" for such devices are related to mechanical strength, biocompatibility, sterilization, and drug elution, rather than diagnostic accuracy or concordance with expert readers.
Therefore, I cannot provide the requested information in the format specific to AI/ML device evaluations.
§ 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.