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The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) 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 the 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 Small Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter. The QUADROX-i Small Adult may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136).

This document is a 510(k) summary for the MAQUET QUADROX-i Small Adult Microporous Membrane Oxygenator. It describes non-clinical testing performed to establish substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria in a way that aligns with the detailed requests of questions 1-9.

The submission focuses on comparing the new device to existing, legally marketed predicate devices, primarily in terms of design, principles of operation, biocompatibility, and performance, as well as meeting recognized standards like ISO 10993-1, ISO 7199, and ISO 15675.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

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

The document states that the device "has been tested to and met the requirements of ISO 10993-1, ISO 7199:1996, and ISO 15675:2001." However, the specific acceptance criteria within these standards and the reported device performance values against those criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions general "testing and evaluation on safety and effectiveness" but does not detail sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the testing described is non-clinical (device performance and biocompatibility), not involving human expert assessment of a test set for ground truth.

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

This is not applicable for the same reason as point 3.

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

There is no mention of an MRMC study or AI assistance. This document describes a medical device (oxygenator), not an AI diagnostic tool.

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

This is not applicable as the device is an oxygenator, not an algorithm.

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

For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the ISO standards mentioned (ISO 10993-1, ISO 7199, ISO 15675). The device's performance was measured against these engineering and biological requirements. No human "expert consensus" or "pathology" ground truth is relevant for device performance.

8. The sample size for the training set

This is not applicable as there is no machine learning or AI component to this device, and thus no "training set."

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

This is not applicable as there is no training set.

Summary of available information:

The 510(k) summary indicates that the QUADROX-i Small Adult Microporous Membrane Oxygenator was subjected to non-clinical testing to demonstrate substantial equivalence to predicate devices and adherence to relevant ISO standards, specifically:

• ISO 10993-1: Biologic Evaluation of Medical Devices
• ISO 7199:1996: Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)
• ISO 15675:2001: Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters

The testing covered:

• Integrity
• Performance (general, no specific metrics provided)
• Biocompatibility
• Sterility

The document explicitly states that the device "met the requirements" of these standards. However, the specific values, acceptance criteria thresholds, or detailed study results are not elaborated upon in this 510(k) summary.

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