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The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The application and use of the oxygenator is the sole responsibility of the attending physician.

The Quadrox D Safeline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

In open heart surgery it is used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Safeline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a model of the Quadrox Safeline Hollow Fiber Membrane Oxygenator. In contrast to the Quadrox, a tight diffusive membrane instead of a microporous membrane is used for the gas exchange.

With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.

The diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.

The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.

The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.

It may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to Jostra Quadrox Safeline Oxygenator (K992559). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator will be provided with a Jostra Manifold Sampling Line.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in terms of patient data or clinical trials. The testing appears to be primarily engineering and bench testing, focused on verifying the device's physical and functional properties. The data provenance is internal testing performed by Maquet Cardiopulmonary AG ("Non-clinical Testing"). There is no mention of country of origin for specific data or whether it was retrospective or prospective.

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

There is no information provided about experts establishing ground truth for a test set. This type of device evaluation relies on objective measurements against established engineering and biological standards (e.g., ISO standards), rather than expert consensus on a "ground truth" derived from clinical cases.

4. Adjudication Method for the Test Set

Not applicable. The evaluation is based on meeting pre-defined standards and specifications through testing, not on adjudicated clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative medical devices where human readers play a critical role in diagnosis or assessment (e.g., radiology AI). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a life-support device, and its performance is evaluated through engineering and biocompatibility testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the testing described appears to be for the standalone device's performance. The "Non-clinical Testing" section states that the device was tested to meet specific ISO standards and for various performance aspects (integrity, performance, stability, biocompatibility, sterility). This refers to the device's inherent functional characteristics, not its performance in conjunction with a human operator.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is established by international consensus standards (ISO 10993-1 and ISO 7199:1996) and the performance characteristics of the legally marketed predicate device (Jostra Quadrox Safeline Oxygenator). The goal of the testing was to demonstrate that the new device meets these established benchmarks and is "substantially equivalent" to an existing, approved device.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's design and manufacturing process would involve extensive engineering development and testing, but these are not described as "training sets" for an AI model.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

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