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The Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.

Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter.

Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholine-based biocompatible material.

The provided document is a 510(k) summary for a medical device called the "Quantum Perfusion Dual Lumen Cannula 31F-V1." It does not describe an AI/ML powered device, therefore the requested information regarding acceptance criteria, study details, and human-AI interaction is not applicable. The document focuses on regulatory approval for an updated version of an existing medical cannula.

Here's a breakdown of why this information isn't available in the document:

• Device Type: The device is a physical medical cannula used in cardiopulmonary bypass, not an AI/ML software or algorithm.
• Approval Type: The document is a 510(k) premarket notification, which is for demonstrating substantial equivalence to a legally marketed predicate device, not for a novel AI/ML application that would require extensive performance studies as requested.
• Performance Data: The "Performance Data" section explicitly states "NON-CLINICAL TESTING" and lists updates to labeling and performance tests according to recognized consensus standards for the physical device. It also states "No animal studies have been performed" and "No clinical data have been included."

Therefore, I cannot provide the requested information for acceptance criteria and study proving device meets said criteria as it pertains to AI/ML devices.

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