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The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1 .0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.

The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit,

The provided document is a 510(k) summary for a medical device (Medos Hilite 7000 & 7000 LT Oxygenator), not an AI/ML product. Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, standalone performance, training set details, ground truth for AI, etc.) are not applicable and cannot be found in this document.

However, I can extract information related to the device's performance testing and the criteria it meets based on the provided text.

Here's a summary of the requested information, adapted for a medical device rather than an AI/ML product:

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

The document does not explicitly present quantitative acceptance criteria in a table alongside reported performance values for each criterion. Instead, it states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." It then lists the types of tests performed. The overall conclusion is that "The Medos Hilite 7000 & 7000 LT Oxygenator meets design specifications," implying that all tested parameters fell within acceptable ranges.

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 quantitative sample sizes for the performance and safety tests. It mentions "extensive safety, performance, and validations prior to release" and "Final testing" as well as specific types of tests. There is no information regarding the data provenance (country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, Medos Medizintechnik AG, located in Germany, suggesting in-house prospective testing.

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 concept is not applicable to the evaluation of this type of medical device. The "ground truth" for device performance typically refers to established engineering specifications, safety standards, and biological compatibility requirements, assessed through laboratory testing by qualified technicians and scientists, rather than expert clinical review of data for diagnostic accuracy.

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

This concept (adjudication for ground truth in diagnostic tests) is not applicable to the engineering and biocompatibility testing of this device.

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 is not applicable as the device is a blood oxygenator, not an AI/ML diagnostic or assistive tool.

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

This is not applicable as the device is a blood oxygenator, not an AI/ML algorithm.

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

The "ground truth" for this device's performance and safety is derived from:

• Established mechanical and material engineering specifications.
• Biocompatibility standards and test protocols (e.g., ISO 10993 series used for cytotoxicity, hemolysis, sensitization, etc.).
• Functional performance specifications (e.g., blood flow rate capabilities, oxygenation efficiency, CO2 removal efficiency, heat exchange capacity – although explicit values are not detailed in this summary, they are implied to be met).

8. The sample size for the training set

This is not applicable as the device is a blood oxygenator, not an AI/ML product that requires a training set.

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

This is not applicable as the device is a blood oxygenator, and no training set or ground truth in that context is relevant.

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