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The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.

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

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

The document does not explicitly state the sample size used for the test set beyond mentioning "In-vitro tests were performed." The data provenance is also not specified; however, given that the manufacturer is based in Germany (Jostra AG, Hirrlingen, Germany) and the submission is to the US FDA, it can be inferred that the testing would have been conducted by the manufacturer, likely in Germany, to meet international standards for device evaluation. The data is retrospective in the sense that it's based on tests conducted on the modified device to compare against an existing predicate device.

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

Not applicable. This submission concerns a device modification, focusing on material change and functional equivalence demonstrated through in-vitro tests, not diagnostic performance requiring expert interpretation of results. No expert adjudication of "ground truth" as typically understood in AI/imaging studies is relevant here.

4. Adjudication method for the test set

Not applicable. As this is not a study involving human interpretation of data for diagnostic purposes, no adjudication method was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This is not an MRMC comparative effectiveness study. This submission is for a modification to a medical device (oxygenator) and relies on in-vitro testing to show substantial equivalence to a predicate device, not on human reader performance.

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

Yes, in a way. The "performance" of the device is evaluated in a standalone manner through in-vitro tests without human intervention in the device's operation or data interpretation during the test, beyond setting up the experiment and analyzing the results. The focus is on the device's physical and functional characteristics.

7. The type of ground truth used

The "ground truth" in this context is the predicate device's established performance and safety profile (Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030, K992559). The new device's performance is compared against the known and accepted performance of this predicate through physical and functional equivalence demonstrated by in-vitro testing. It's about demonstrating that the modified device performs effectively identically to the previously approved one, despite a material change.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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