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The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

The provided text does not contain detailed information about specific acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for the Cardeon Aegis™ Catheter in the way requested in the prompt. The document is a 510(k) summary and an FDA clearance letter, which typically focus on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with the requested metrics.

The document states:

• Substantial Equivalence: "The determination of substantial equivalence was also based on an Product Testing: assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as a predicate devices."
• Performance Claim: "Differences between the Aegis Catheter and other devices do not alter or diminish the rate of arterial return required during cardiopulmonary bypass."

However, it does not provide the granular details requested in the prompt about specific acceptance criteria or the study that proved the device met them. It generally states that testing demonstrated safety and effectiveness compared to predicate devices.

Therefore, I cannot fully populate the requested table and answer all the questions based on the provided text.

Based on the provided text, here is what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Note: The document emphasizes substantial equivalence to predicate devices and general statements about biocompatibility and performance rather than specific, quantitative acceptance criteria that would typically be found in a detailed study report.

Study Details

1. Sample sizes used for the test set and the data provenance: Not specified in the provided text. The document mentions "in vitro and in vivo performance" testing but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified in the provided text. This type of information is typically related to diagnostic devices or image analysis, not physical medical devices like catheters, where "ground truth" might be established through direct measurement or observation during testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for performance testing of a physical medical device like this catheter.
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 study type is for AI/diagnostic devices and involves human readers assessing cases. The Cardeon Aegis™ Catheter is a physical device for perfusion.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This study type is for AI/diagnostic devices. The Cardeon Aegis™ Catheter is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in the context of "ground truth" as typically defined for AI/diagnostic devices. For this type of device, "ground truth" would likely refer to objective measurements of flow rates, pressure, material integrity, and biocompatibility observed during in vitro and in vivo testing, often compared against established medical standards or predicate device performance.
7. The sample size for the training set: Not applicable. Training sets are for machine learning algorithms. The Cardeon Aegis™ Catheter is a physical medical device.
8. How the ground truth for the training set was established: Not applicable.

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