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These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.

The Medtronic ClearView® Intravascular Arteriotomy Shunt is a temporary arterial shunt for use during coronary artery bypass grafting procedures (CABG). The device features two teardrop shaped bulbs over-molded onto the ends of a flexible tubular shaft. The device is provided in nine sizes. A tag attached to each device identifies size. The device is radiopaque.

The provided document does not describe the acceptance criteria or a study proving the device meets them in the context of an AI-powered medical device. This document is a 510(k) Summary for a Medtronic ClearView® Intravascular Arteriotomy Shunt, which is a physical medical device (a temporary arterial shunt for use during coronary artery bypass grafting procedures).

Therefore, I cannot provide answers to the requested information (1-9) as they pertain to the evaluation of AI/ML-based medical devices.

The document focuses on non-clinical performance data for a physical device, including:

• Biocompatibility testing: Performed according to ISO 10993-1, testing for cytotoxicity, hemolysis, sensitization, systemic toxicity, and intracutaneous toxicity. All tests were negative.
• Flow Curve testing: Compared the shunt's flow characteristics to a predicate device, showing equivalent or better flow.
• Radiopacity testing: Confirmed that the shunt's radiopaque components were visible via radiographic imaging on a phantom chest device.
• Tensile Strength testing: Demonstrated the device could withstand physical forces exceeding normal usage without failure.

The conclusion states that these non-clinical tests indicate the device is safe and effective for its indicated use and substantially equivalent to the predicate device.

To reiterate, the questions asked (1-9) are specific to the evaluation of AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, use of expert-annotated test sets, MRMC studies), which are not applicable to the physical medical device described in this 510(k) summary.

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