(45 days)
Atrium ProLite Ultra 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.
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I am sorry, but the provided text is a 510(k) clearance letter for the Atrium Prolite Ultra S Mesh. This document is a regulatory communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of details would typically be found in the 510(k) submission summary or in a separate study report, which is not included in the provided text.
Therefore, I cannot fulfill your request for that specific information based on the given input.
§ 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.