(78 days)
The Specialty Surgical Products Ventral Wall Defect Reduction Silo is indicated for use in the treatment of I he opecially burgiour routed "remat" oschisis and ompalocele, where primary closure attempts must be abandoned in favor of a staged repair.
Ventral Wall Defect Reduction Silo
The provided document is a 510(k) clearance letter from the FDA for a device called "Ventral Wall Defect Reduction Silo." This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. This process generally relies on comparing the new device's technological characteristics and indications for use to a predicate device, rather than requiring new clinical studies with pre-defined acceptance criteria and performance metrics.
Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory approval letter.
§ 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.