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Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surqical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

The provided text describes a 510(k) premarket notification for a medical device, the "Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U" and "Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U". This document outlines the device's characteristics, intended use, and comparison to predicate devices. It states that the submission does not include clinical data and relies on non-clinical testing to demonstrate substantial equivalence.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, particularly those related to human-in-the-loop performance, expert ground truth, and training sets, are not applicable to this submission. This device is a traditional medical device (oxygenator), not an AI/ML-powered diagnostic or therapeutic tool.

Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted, but does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for the device alongside those criteria. It only states that "all testing passed by meeting the established requirements."

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for the non-clinical performance tests (e.g., how many oxygenators were tested for gas exchange). The tests are described as "non-clinical testing" and appear to be laboratory or bench testing. Data provenance is not applicable in the sense of patient data; it's device performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an oxygenator, not an AI/ML diagnostic. Ground truth would be defined by engineering specifications and physical measurements, not expert consensus on medical images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to human review of ground truth in AI/ML performance studies, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device. The submission explicitly states "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate devices."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm. The performance tests mentioned (gas exchange, hemolysis, etc.) are inherent performance characteristics of the physical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of traditional medical device, "ground truth" for performance relates to:

• Engineering specifications and standards: Adherence to established performance parameters outlined in standards like ISO 7199 for Cardiopulmonary Bypass Oxygenators.
• Physical and chemical measurements: Examples include flow rates, pressure drops, gas transfer rates (O2 and CO2), and hemolysis rates.
• Biocompatibility testing results: As per ISO 10993.

8. The sample size for the training set

Not applicable. This is not an AI/ML-powered device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/ML-powered device.

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