(105 days)
The Surgipro* Mesh Plug** device is indicated for the repair of groin hernia defects.
Surgipro* Mesh Plug** device is a nonabsorbable, inert sterile, porous, surgical mesh knitted from yarns o polypropylene polymer from which Surgipro* surgical sutures are manufactured.
The provided text is a 510(k) summary for a medical device (Surgipro™ Mesh Plug) and a letter from the FDA. It does not contain any information about a study proving the device meets acceptance criteria, nor does it mention any performance metrics, sample sizes, expert involvement, or any of the other specific details requested in the prompt for AI/algorithm performance.
This document is a regulatory submission for a physical medical device (surgical mesh), not an AI/algorithm-based device. Therefore, a study proving the device meets acceptance criteria in the context of AI (e.g., accuracy, sensitivity, specificity, F1 score) is not applicable here.
The document primarily focuses on establishing substantial equivalence to predicate devices for its intended use (repair of groin hernia defects) and regulatory classification.
§ 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.