(244 days)
The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.
The original NuVasive Surgical Mesh System consists of a series of specialized shapes and sizes of mostly flat embroidered mesh and a radiographic marker. The meshes typically contain pre-formed reinforced holes to provide secure and easy to find suture or tissue anchor locations.
The provided text is a 510(k) summary for a surgical mesh system. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information requested for acceptance criteria and a study proving device performance.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details of MRMC or standalone studies, or information on training sets and their ground truth establishment.
The document explicitly states:
- Summary of Non-Clinical Tests: (Not Applicable).
- Summary of Clinical Tests: (Not Applicable).
This indicates that no specific non-clinical or clinical studies for acceptance criteria and device performance, as typically understood for in vitro diagnostic or AI/ML-based devices, were performed or required for this 510(k) submission. The FDA cleared the device based on its substantial equivalence to a legally marketed predicate device, with identical indications for use and principles of operation, without requiring new performance data.
§ 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.