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The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Cordis ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.

This document describes a premarket notification for a medical device (Cordis ST Steerable Guidewire). It does not contain information about software or AI, nor does it detail a study involving acceptance criteria for device performance. Instead, it focuses on general device description, classification, and biocompatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. These details are typically found in documents related to performance testing, often for software-based medical devices or devices undergoing specific clinical trials.

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The Cordis CINCH® OR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter

The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDETM . The extension is 145 cm long and has a shaft diameter of 0.014 inches.

This document is a 510(k) premarket notification for a medical device (Cordis CINCH® QR Steerable Guidewire Extension). It is not a study report demonstrating the device meets acceptance criteria, nor does it contain information about clinical performance or AI algorithm validation.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory submission details like device description, intended use, and equivalence to predicate devices, and explicitly states that "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." and "Biocompatibility testing was not repeated".

To answer your questions, I would need a different type of document, such as a clinical study report or a validation study for an AI-powered device.

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