(108 days)
The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.
Valved Tearaway Introducer Generation II
I am sorry, but the provided text from the FDA 510(k) letter for the "Generation II Valved Tearaway Introducer" does not contain information about acceptance criteria, study details, or performance data for a device in the context of an AI or diagnostic algorithm.
The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as product codes, regulations, and general controls, but it does not include any technical or clinical study details that would allow me to answer your specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or AI performance metrics.
Therefore, I cannot provide the requested information based on the text provided.
§ 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).