(28 days)
Performer™ Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.
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The provided text is a 510(k) premarket notification letter from the FDA to Cook Incorporated for the Performer Introducer device. It confirms the device's substantial equivalence to legally marketed predicate devices.
However, this document does NOT contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the device's functional performance or an AI/software component.
The document is purely a regulatory approval letter for a physical medical device (catheter introducer) and does not describe a study involving algorithms, AI, or performance metrics in the way your request specifies. The "Indications for Use" section simply states the device's intended purpose ("introduce therapeutic or diagnostic devices into the vasculature") and confirms it's for Prescription Use.
Therefore, I cannot fulfill your request based on the provided text. To answer your detailed questions, I would need a different type of document, such as a clinical study report, a performance evaluation report, or a 510(k) submission summary that includes detailed performance data for an AI or software device.
§ 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).