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The Affinity NT Oxygenator with Cortiva™ BioActive Surface is intended to be used 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 device listed in this 510(k) Notification is a single use, non-toxic, non-pyrogenic, and is supplied sterile in packaging.

The Medtronic Affinity NT Oxygenator is a single use device designed to oxygenate and remove carbon dioxide from the blood and with the heat exchanger and arterial filter cools or warms the blood during extracorporeal circulation. The oxygenator has a blood contacting Cortiva™ -BioActive Surface.

The Affinity NT Hollow Fiber Oxygenator (Affinity NT Oxygenator) is intended to be used 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.

Affinity NT Oxygenator is designed to be an integral part of the cardiopulmonary heart lung bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a blood pump to the oxygenator and other auxiliary devices, and back to the patient.

The purpose of this 510(k) Notification is to notify the FDA of a labeling change to the disinfectant warning on the Instructions for Use to allow for disinfectant use in the water path of the oxygenator as well as report previous changes for the Affinity NT Oxygenator model included in this submission.

The provided text is a 510(k) premarket notification for the Medtronic Affinity NT Oxygenator with Cortiva™ Bioactive Surface. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding a labeling change and previous modifications.

This document does not contain information on acceptance criteria for device performance related to a study proving the device meets those criteria, nor does it describe a study like a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The content of this document suggests that the device in question is a medical device (oxygenator) rather than an AI/ML powered device, which is relevant to why such information is absent.

Therefore, many of the requested details cannot be extracted from this document, especially those pertaining to AI/ML device performance and ground truth establishment.

However, I can provide information based on the performance tests conducted to verify the device's characteristics, as described:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

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 information is not provided in the document. The tests described are engineering/mechanical performance tests, not clinical evaluations requiring expert interpretation.

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

This information is not applicable and not provided in the document. The performance tests are objective engineering measurements.

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

An MRMC study was not done, and this device is not an AI-powered device. Clinical testing was explicitly stated as not required to establish substantial equivalence for this submission.

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

A standalone performance evaluation of an algorithm was not done, as this is not an AI-powered device.

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

The "ground truth" for the performance tests appears to be engineering specifications and measurements. For example, the water path resistance to pressure is a quantitative engineering specification.

8. The sample size for the training set

This information is not applicable and not provided in the document, as this is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided in the document.

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