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The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting up to six hours.

The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger. Microporous polypropylene, hollow fiber membrane material separates the blood and gas pathways inside the oxygenator, with the blood pathway outside and the gas pathway inside the hollow fiber membrane. Blood is pumped into the blood inlet port. The blood inlet and blood outlet ports are 3/8" and include a locking mechanism which accepts a 1/4" reducing connector if the user desires to utilize 1/4" ID rather than 3/8″ ID circuit tubing. The blood is channeled into the blood pathway of the heat exchanger, where the blood temperature is varied by controlling the water temperature in the water pathway of the heat exchanger. As the blood exits the heat exchanger it passes around a stainless steel temperature probe well, where the temperature of the blood may be monitored as it enters the oxygenator. Blood from the heat exchanger enters the oxygenator through the inlet manifold, and then flows around the outside of the fibers are oriented horizontally in the oxygenator case, with flow entering the top of the fiber bundle and exiting the bottom to facilitate priming and debubbling. Gas exchange takes place as the blood makes its way into the bottom outlet manifold where it is directed out of the oxygenator through the blood outlet port and back to the patient. Sweep gas is introduced into the fibers through the gas inlet cap. The gas flows through the lumen of the hollow fibers. Gas exchange between the blood and gas pathways takes place through the micropores in the hollow fiber wall. Sweep gas flowing through the fibers collects in the outlet cap, where it may be scavenged.

The COBE® Optimin™ Hollow Fiber Membrane Oxygenator demonstrated substantial equivalence to predicate devices (COBE® Optima XP™ and TERUMO® Capiox® SX 10) through in-vitro testing. The submission does not provide explicit acceptance criteria values, but instead states the device performance "supports substantial equivalence" based on various in-vitro tests.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not explicitly state specific numerical acceptance criteria for each test. Instead, it indicates that the in-vitro test data "support substantial equivalence" to the predicate devices. This implies that the device's performance fell within an acceptable range compared to the predicate devices, but the exact thresholds are not detailed 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)

The document does not specify the sample size used for the in-vitro testing.
The data provenance is in-vitro testing – meaning testing performed outside a living organism, typically in a lab setting. The country of origin of the data is not specified, but the submission is to the US FDA. The nature of in-vitro testing makes the retrospective/prospective distinction less applicable in the typical clinical study sense.

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 section is not applicable to this type of device submission. The "ground truth" for the performance characteristics of an oxygenator in in-vitro testing is typically established by established engineering standards, validated laboratory protocols, and comparison to the performance of predicate devices, rather than expert consensus on medical images or clinical outcomes.

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

This section is not applicable. Adjudication methods are typically relevant in studies involving human interpretation or clinical endpoints, which is not the case for these in-vitro mechanical and biological performance tests.

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

This section is not applicable. This device is a medical device (oxygenator), not an AI diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant to its evaluation.

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

This section is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on established engineering and biological principles for oxygenator function, validated in-vitro testing methods, and direct comparison to the physical and functional characteristics of legally marketed predicate devices. It's not based on expert consensus, pathology reports, or patient outcomes data in the context of this 510(k) submission for substantial equivalence based on in-vitro data.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This section is not applicable as there is no training set for a physical medical device.

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