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The device is intended to be used as perfusion cannulae to return arterial blood from the extracorportal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.

The devices are intended to be used to cannulate the arterial vessels during cardiopulmonary bypass surgery. They are sterile, single use devices.

These cannulae are comprised of three main components:

1. A barbed proximal end connector to attach to cardiopulmonary bypass tubing. A female luer lock connector is also optionally available to provide venting and can be oriented up or down.
2. Single-lumen polymer tubing with an optional wire reinforcement to prevent kinking.
3. A straight or bent tip that is inserted into the patient. The Aortic Arch Cannulae has a monodimensional tip design whereas the Optiflow Aortic Arch Cannulae has a three dimensional basket tip design.

The provided text is a 510(k) summary for a medical device (Aortic Arch Cannulae), and it does not contain information about an AI/algorithm-based device or its evaluation. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance for an AI/algorithm.

The document discusses:

• The device: Aortic Arch Cannulae and Optiflow Aortic Arch Cannulae, which are physical medical devices (perfusion cannulae).
• Modifications: Changes in plasticizer, tip design, and outer diameter sizes.
• Testing: Non-clinical in vitro tests (blood trauma, tensile force, structural integrity, kink resistance, pressure-flow, shipping/packaging) conducted to demonstrate substantial equivalence to predicate physical devices.

Therefore, I cannot fulfill your request for information related to AI/algorithm performance and evaluation from this document.

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