(95 days)
The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
The PTFE Super Sheath Introducer 2.1 is a catheter introducer. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.
The provided text is a 510(k) premarket notification for a medical device (PTFE Super Sheath Introducer 2.1) and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.
The document discusses substantial equivalence to a predicate device (PTFE Super Sheath Introducer 2.0, K130855) for a physically manufactured medical instrument, not a software-based AI/ML device. The "Bench / Performance Data" section lists in-vitro tests performed, but these are for the physical properties of the introducer, such as liquid leakage, air leakage, force at break, simulated use, and equipment interaction. There is no mention of an algorithm, AI, or machine learning model.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details) because the provided text is not about an AI/ML medical device study.
§ 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).