(26 days)
The Parietex® Polyester Mesh is indicated for use in the reinforcement of tissue during surgical repair of inguinal hernias through laparoscopic approach.
The Parietex® Polyester Mesh will be packaged with an Introducer. Suture loops are attached to the meshes and aide in inserting and removing the mesh from the Introducer.
The provided text describes a 510(k) premarket notification for a medical device, the Parietex® Polyester Mesh. However, the document focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain information about a study that establishes acceptance criteria for device performance in the context of an AI/ML algorithm.
The "PERFORMANCE DATA" section explicitly states: "Bench tests were conducted to demonstrate that the modification to the device did not change the performance when compared to the predicate device." This indicates that the performance evaluation was a comparison to an existing device, not an establishment of new performance criteria for an AI/ML system.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as this document pertains to a traditional surgical mesh and not an AI/ML device.
To answer your request, I would need a document describing the performance evaluation of an AI/ML medical device.
§ 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.