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The SAFE MAXI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

SAFE MAXI venous/cardiotomy reservoir is a hard shell reservoir with separate venous and cardiotomy inlets. The venous inlet with 175 micron venous filter is placed at the bottom of the reservoir, which provides a bottom to top venous blood flow. Returning suction blood enters the large surface area 20 micron depth filter at the top of the reservoir. The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.

This 510(k) summary describes a medical device, the SAFE MAXI venous/cardiotomy reservoir, and its claim of substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving the device meets them through a dedicated study with defined metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted directly from this document.

However, based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating similar characteristics and comparable performance to predicate devices to establish substantial equivalence.

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

The document does not specify a distinct "test set" in the context of a clinical or performance study with a defined sample size. The evaluation appears to be based on:

• Biocompatibility: Likely laboratory testing, potentially on material samples or the predicate device.
• Blood Cell Damage Test: This was performed using a "same blood pool" setup, suggesting a comparative in vitro or ex vivo experiment. The number of samples or runs is not specified.
• Effectiveness Testing: "Evaluating its operational characteristics" suggests various engineering or bench tests.

Data Provenance: Not explicitly stated, but given the manufacturer (POLYSTAN A/S, Denmark), the testing would likely have taken place in a laboratory setting, possibly in Denmark or the US. The nature of these tests (e.g., in vitro, bench testing) means they are not "retrospective" or "prospective" in the clinical trial sense.

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

Not applicable. This type of device evaluation (substantial equivalence to predicates for a physical component) does not involve expert consensus on "ground truth" derived from clinical cases, as would be common for diagnostic algorithms or imaging devices.

4. Adjudication Method for the Test Set

Not applicable. As above, this isn't a study design that involves expert adjudication of findings.

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 device is a passive medical component (blood reservoir) and does not involve AI or human "readers."

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

Not applicable. This device is a physical component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices. The device's substantial equivalence is established by demonstrating (through laboratory/bench testing) that its performance and safety characteristics are comparable.

• Biocompatibility: Chemical and biological testing standards (e.g., ISO 10993).
• Blood Cell Damage: Measured parameters (e.g., free hemoglobin, platelet activation) in an in vitro setup.
• Effectiveness: Engineering performance metrics (e.g., flow rates, defoaming efficiency, filtration efficacy, volume capacity).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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