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The Medtronic AFFINITY® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface is intended for use in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The Medtronic AFFINITY Oxygenator with Balance" Biocompatible Surface is a single-use, disposable, sterile, nonpyrogenic fluid path, gas exchange device with a self contained, venous-side heat exchanger for regulating blood temperature. The microporous polypropylene hollow fibers are wound around a core and encased in a plastic outer shell. Oxygen flows through the hollow fibers and blood flows from the stainless steel heat exchanger around the hollow fibers. Gas exchange occurs by diffusion across the hollow fiber membrane. A gas outlet is provided for scavenging, and a gas vent prevents over pressurization. The modification to the currently marketed AFFINITY® Hollow Fiber Oxygenator is to coat the primary blood contact surfaces with a non-leaching, biocompatible coating (Balance™).

The provided text is a 510(k) submission for a medical device, specifically an oxygenator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of quantitative acceptance criteria through a standalone clinical study. Therefore, general acceptance criteria and performance data are discussed in the context of comparison to the predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating that the new device, the AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface, does not raise new safety or effectiveness concerns compared to its predicate devices and performs comparably. The "reported device performance" refers to the results of in vitro bench testing and biocompatibility testing.

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

The document does not specify a "test set" in the sense of a clinical trial patient cohort. The evaluation was done through in vitro bench testing and biocompatibility testing.

• Sample Size: Not explicitly stated for each test. The testing would involve a certain number of device units or components subjected to standardized laboratory tests.
• Data Provenance: The testing was conducted by Medtronic Perfusion Systems. The provenance is internal company testing, likely done in a lab setting, rather than from a specific country of origin or being retrospective/prospective clinical data. It is retrospective in the sense that the data was collected for the purpose of this 510(k) submission.

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

This information is not applicable to this type of submission. Ground truth, in the context of expert review, is typically associated with diagnostic devices where expert interpretation of images or other data is compared against device output. Here, the "ground truth" for the bench tests would be the established scientific methods and engineering specifications.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical trials or studies involving expert consensus, which are not described here. The "adjudication" for the bench testing would be the interpretation of the test results against predefined engineering and performance standards by qualified engineers and scientists.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study investigates how human readers' performance (e.g., diagnostic accuracy) changes with or without the assistance of an AI algorithm. The device in question is an oxygenator, which is a therapeutic device, not a diagnostic one that would typically involve human "readers" interpreting output.

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

This question is not applicable as the device is a medical apparatus (oxygenator), not an AI algorithm. It functions autonomously in terms of gas exchange and heat regulation within the extracorporeal circuit.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the performance evaluation was established through:

• Established scientific methods and engineering standards: Referenced standards include ISO/DIS 7199, BG7199-1996, and ISO 10993-1. These standards define the acceptable performance and safety parameters for blood-gas exchangers and biocompatibility.
• Comparison to predicate devices: The "ground truth" for demonstrating substantial equivalence is the known safety and effectiveness of the legally marketed predicate devices (AFFINITY® Hollow Fiber Oxygenator and MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface). The new device's performance data was compared against the expected performance of these predicates.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data. The device's design and manufacturing are based on engineering principles and established medical device development processes.

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

This is not applicable as there is no training set mentioned or implied for this device.

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