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The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the QUART Arterial Filter is 71/min.

The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.

The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line.

Utilization of the QUART Arterial Filter therefore reduces the patient risk of injury from a micro-embolism resulting from gases or solids.

This 510(k) summary describes a device modification rather than the development of a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device submissions, are not applicable here.

The submission focuses on demonstrating substantial equivalence of the modified device (QUART Arterial Filter with SOFTLINE COATING) to its predicate devices by comparing technical characteristics and performance based on standard medical device testing, not AI/ML algorithm validation.

However, I can extract the relevant information presented in the document regarding the device modification and the testing performed to demonstrate substantial equivalence.

Device Description:
The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line, reducing patient risk from micro-embolisms.

Device Modification:
The QUART Arterial Filter with SOFTLINE COATING is identical to the QUART Arterial Filter with Safeline Coating, with the only exception that it has been coated with SOFTLINE. The SOFTLINE COATING is the same as that used with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING. Besides this difference, both QUART Arterial Filters are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.

Acceptance Criteria and Reported Device Performance (as implied by the substantial equivalence determination):

The submission does not list specific numerical acceptance criteria in a table format, as would be expected for AI/ML performance metrics. Instead, it asserts that the modified device's performance aligns with the predicate devices through evaluation and testing. The "reported device performance" is essentially that it meets the expected standards for an arterial filter and is substantially equivalent to the predicate devices.

Study Information (for a device modification, not an AI/ML algorithm):

1. Sample sizes used for the test set and the data provenance: Not applicable. This submission concerns a physical device modification, not a software algorithm tested on data sets. The "testing" refers to bench testing and material compatibility, not analysis of a data set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic AI/ML algorithms, not for evaluating a physical device modification.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in ground truth labeling.
4. 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 a physical medical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the physical properties and biological interactions of the device materials and function, assessed through standard engineering and biological testing (e.g., biocompatibility testing, flow rate performance, particulate removal efficiency against a known standard).
7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. This pertains to AI/ML algorithm development.

Conclusion stated in the 510(k):
"The data given demonstrate that the QUART Arterial Filter with SOFTLINE COATING is substantially equivalent to the named predicate devices which hold currently market clearance."

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