(117 days)
Atrium ProLite S Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
Not Found
This document is a 510(k) clearance letter from the FDA for the Atrium ProLite S Mesh. It confirms that the device is substantially equivalent to a predicate device for specific indications of use (hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material).
However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter is a regulatory approval based on demonstrating substantial equivalence, not a summary of a performance study with specific metrics and methodologies.
Therefore, I cannot provide the requested information based on the provided text. The document is solely an FDA clearance letter and does not include the details of a performance study.
§ 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.