(237 days)
The Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
The finished device is a tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed of the same or similar materials. The device is being modified to add a tear-away hemostasis valve. The combined performance characteristics of the predicate devices are unchanged and are consistent with other legally marketed predicate devices.
The provided document is a 510(k) summary for a medical device (GaltVTI™ Valved Tearaway Introducer) and its FDA clearance letter. It describes the device's intended use, materials, and performance testing for demonstrating substantial equivalence to predicate devices. However, the document does NOT contain information related to an AI/ML device, a clinical study involving human readers or AI assistance, or data provenance. Therefore, I cannot fulfill most of your request regarding acceptance criteria for an AI device or a study proving device performance as it pertains to AI/ML.
I can only extract information related to the device's non-AI performance testing.
Here's the relevant information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria (e.g., "leak rate must be
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).