(90 days)
DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-POSTERIOR is a textile structure knitted from non-absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 from Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a ziqzag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates a rapid orientation and visual monitoring of whether the mesh is positioned tension-free. The used green dye is Phtalocyanine green, CAS1328-53-6, PG7 from BASF. DynaMesh®-POSTERIOR is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-POSTERIOR will be packed in a cardboard box. Within the cardboard box the device will be doublepacked in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
The provided text is a 510(k) summary for the DynaMesh®-POSTERIOR surgical mesh. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.
The document describes a medical device, a surgical mesh, which is a physical implant, not an AI/ML software device. The listed "Summary of Non-Clinical and Clinical Data" refers to laboratory bench tests (e.g., Burst Strength Test, Tensile Strength, Porosity Test) conducted on the physical mesh to demonstrate its performance and substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance from an AI/ML study, sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, or standalone algorithm performance. This information is not relevant to the type of device and submission described in the provided text.
§ 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.