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The Quantum Perfusion Arterial Cannula Graft is designed to the patient through an arterial vessel during cardiopulmonary bypass procedures for periods of maximum 6 hours. The device is equipped with an additional valved access which allows accessing arterial circulation.

The Quantum Perfusion Arterial Cannula Graft is a standalone single use device intended to be used in medical procedures requiring extracorporeal life support. It is designed to infuse blood coming from extracorporeal circuit into the patient's vascular district while being sutured to an arterial vessel.

The device also consists of a 3/8″ barbed connection with a side branch containing a hemostatic valve. Due to this valve, the Quantum Perfusion Arterial Cannula Graft can also act as an additional access for interventional catheterization. This feature allows the clinician to perform a single site access during medical procedures, avoiding multiple site access and thus reducing invasiveness.

The application duration of the Quantum Perfusion Arterial Cannula Graft is 6 hours.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch.

The provided text describes the 510(k) summary for the Quantum Perfusion Arterial Cannula Graft. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria and device performance in the context of an AI-powered diagnostic device, which your questions pertain to.

The device discussed is a physical medical device (an arterial cannula graft) for cardiopulmonary bypass procedures, not an AI/ML-driven software or diagnostic tool. Therefore, the questions regarding AI/ML performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable to the information contained in this document.

The document states:

• No clinical data were included to support substantial equivalence.
• No animal studies were performed except for mandatory biocompatibility tests.
• In-vitro testing was performed to demonstrate substantial equivalence and compliance with user needs and safety/effectiveness requirements.

The non-clinical testing included:

• Evaluation of device performances (pressure drop, valve backflow and leakage, graft water entry pressure, suture retention strength, dynamic blood damage, kinking resistance, mechanical integrity) according to specific ISO standards.
• Evaluation of product shelf life and sterility.
• Validation of EtO Sterilization process.
• Packaging Validation tests.
• Biocompatibility testing according to ISO 10993-1:2018.

Conclusion stated in the document:
"Based on the indications for use, technological characteristics and results of non-clinical testing, the Quantum Perfusion Arterial Cannula Graft has been demonstrated to its intended use and is considered substantially equivalent to claimed predicate VASCUTEK CANNULA GRAFT, cleared by K081560."

Since your request is tailored for AI/ML device evaluations, and this document describes a physical medical device, I cannot provide answers to most of your specific questions based on the input provided.

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