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The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature.

The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um.

The device's utilization period is limited to six hours. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.

The provided text describes a 510(k) submission for a medical device, the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through a clinical study. Therefore, most of the requested information (e.g., sample size for test sets, number of experts for ground truth, MRMC studies) is not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to demonstrating that the new device meets the same safety and performance profiles as its predicate devices, primarily through non-clinical testing.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly that the new device (with "BIOLINE Coating") performs equivalently to the predicate devices (with "Softline Coating" for the oxygenator and "BIOLINE Coating" for the arterial filter component). The submission states that testing was undertaken to demonstrate this equivalence. Specific numerical thresholds for performance are not explicitly detailed in this summary, but would be part of the full submission.

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is a non-clinical evaluation comparing the new device against its predicate devices. The submission states:

"Evaluation and testing on safety and effectiveness was executed to demonstrate that the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with BIOLINE Coating described in this submission is substantially equivalent to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating as oxygenator and to the QUART Arterial Filter with BIOLINE Coating regarding the BIOLINE coating."

The areas tested included:

• Integrity
• Performance
• Biocompatibility
• Sterility

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. Given that this is a non-clinical submission, the "test set" would refer to the number of devices or components tested. The data provenance would likely be internal testing data from the manufacturer (MAQUET) in Germany. This is not a study involving patient data or clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This point is not applicable. "Ground truth" established by experts typically pertains to clinical diagnostic studies where human experts evaluate medical images or patient data. This 510(k) is for a physical medical device (oxygenator/filter) and relies on technical and performance testing, not expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

This point is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among expert readers in establishing ground truth. As explained above, this submission does not involve such expert-based ground truth establishment.

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

This point is not applicable. MRMC studies are relevant for evaluating the impact of AI in diagnostic imaging or clinical decision support where "human readers" interpret information. This 510(k) is for a physical device used during cardiopulmonary bypass, not an AI-driven diagnostic tool.

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

This point is not applicable. Standalone algorithm performance is relevant for AI or software as a medical device. This 510(k) concerns a physical, mechanical medical device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through objective engineering and laboratory testing based on established standards and methods for medical device performance, integrity, biocompatibility, and sterility. For example, "performance" would likely be measured against accepted physiological parameters (e.g., oxygen transfer rate, CO2 removal rate, filtration efficiency) under simulated in-vitro conditions, with the predicate device's performance serving as the reference for equivalence.

8. The Sample Size for the Training Set

This point is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) is not for an AI/ML device.

9. How the Ground Truth for the Training Set was Established

This point is not applicable for the same reason as point 8.

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