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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.

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