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The Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for:

• an air/fluid separation chamber;
• a temporary storage reservoir for priming solution and blood;
• the filtration of particulates from bank blood and filtration of blood recovered from the field by suction:
• the addition of medications or other fluids.

The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for:

• the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

The Intersept™ Filtered Cardiotomy Reservoir is a single-use, device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is 2,600 ml. The maximum recommended flow rate is 2 liters per minute (LPM).

Each reservoir has eight luer or 1/4" (0.6 cm) ID access ports;

• four suction access ports .
• two pre-defoamer and two post-defoamer access ports. One of the post-defoamer access . ports is intended for use as a vent.

Each Intersept™ Filtered Cardiotomy Reservoir contains an open cell polyurethane defoamer with a 20 micron microaggregate filter covered with a polyester sleeve.

This document is a 510(k) premarket notification for the Intersept™ Filtered Cardiotomy Reservoir. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with reported performance metrics in the format requested.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth details for training and test sets) cannot be fully answered from the provided text. The document is primarily a regulatory submission for a medical device, which often uses comparison to a predicate as the basis for clearance, rather than presenting a novel clinical study with detailed performance metrics against pre-defined acceptance criteria.

However, based on the provided text, here is what can be inferred and explicitly stated:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device in terms of performance. The "Results" column only states "Pass," indicating that the device met the performance standards demonstrated by the predicate.

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

The document does not specify the sample sizes used for the "Filtration Efficiency," "Blood Trauma," or "Biocompatibility" tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. The document describes engineering and biological testing, not a study involving ground truth established by medical experts for diagnostic interpretation.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

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

For the tests mentioned:

• Filtration Efficiency: The ground truth would likely be established through standard laboratory methods for measuring particle retention (e.g., gravimetric analysis or particle counting) against a known challenge.
• Blood Trauma: Ground truth would be established through laboratory analysis of blood samples (e.g., measurement of hemolysis, platelet activation, or other markers of blood damage) directly comparing the device's impact to that of the predicate or established benchmarks.
• Biocompatibility: Ground truth is established through standardized in-vitro and/or in-vivo testing according to ISO 10993 series for medical devices.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning model, so there is no training set.

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

Not applicable. There is no training set.

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