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The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.

The provided text is a 510(k) summary for a medical device (Quantum Perfusion Hybrid System) and primarily focuses on proving substantial equivalence to predicate devices through non-clinical testing. It does not contain information about a study proving device performance against specific acceptance criteria for an AI/software-driven device.

Therefore, I cannot provide the requested information, as the document details a traditional medical device submission, not one related to an AI/ML component with associated performance studies (MRMC, standalone algorithm, ground truth establishment, etc.). The document explicitly states: "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." and "No animal studies have been performed except for mandatory biocompatibility tests...".

The non-clinical testing mentioned is focused on general device performance for a cardiopulmonary bypass blood reservoir, such as pressure drop, mechanical resistance, air handling, and filtration efficiency, verifying it meets established engineering requirements for this type of device, which are inherent to the device's design and function rather than a set of statistical acceptance criteria that would typically be associated with an AI/ML algorithm's performance.

To answer your request, a document detailing an AI/ML device would be needed, specifically discussing its performance study, acceptance criteria, test set details, ground truth, and potentially MRMC study results.

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