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The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface 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 (CPB) procedures up to 6 hours in duration. The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The Affinity Fusion™ Cardiotomy/Venous Reservoir with Balance™ Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures. The Affinity Fusion™ Cardiotomy/Venous Reservoir with Balance™ Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood volume replacement.
The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and 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 (CPB) procedures up to 6 hours in duration. The Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The 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 (CPB) procedures up to 6 hours in duration.
The Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface 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 Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Plasma Resistant Fiber [PRF] Oxygenator with Trillium Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator with Trillium™ Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
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 (CPB) procedures up to 6 hours in duration.
The Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

Not Found

The provided document is an FDA 510(k) clearance letter for various models of Affinity™ Oxygenators and related devices. It specifies the indications for use for each device. However, this document does not contain any information regarding acceptance criteria, study designs (e.g., sample sizes, human expert involvement, ground truth establishment, or multi-reader multi-case studies) or performance metrics for AI/ML-driven devices.

The devices listed are traditional medical devices used in cardiopulmonary bypass procedures, such as oxygenators and cardiotomy/venous reservoirs. There is no mention of any AI or machine learning components associated with these devices. Therefore, I cannot extract the information required to answer your prompt about acceptance criteria and studies proving an AI device meets those criteria.

To answer your prompt, I would need a document describing the validation study of an AI/ML-driven medical device.

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Model 511:

The 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 (CPB) procedures up to 6 hours in duration.

Model 511T:

The Affinity NT Oxygenator with Trillium Biosurface 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 (CPB) procedures up to 6 hours in duration.

The device listed in this 510(k) Notification is 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 either a blood contacting Trillium™ Biosurface or is uncoated.

The 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 then 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 models included in this submission.

The request concerns a 510(k) submission for the Medtronic Affinity NT Oxygenator (Models 511 and 511T). This document is a regulatory notice granting 'substantial equivalence' and does not describe a study evaluating an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., in terms of clinical performance, ground truth, expert consensus, MRMC studies, etc.).

The device is a cardiopulmonary bypass oxygenator, which is a physical medical device, not an AI/ML product. The performance data provided is related to its mechanical integrity and basic function rather than diagnostic or analytical performance.

Therefore, many of the requested fields are not applicable to this type of device and submission.

Here's the relevant information that can be extracted, and an explanation for why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document for the mechanical tests.
• Data Provenance: Not specified. Testing was conducted internally by Medtronic. It is a pre-market submission, so the data is prospective relative to the submission but does not involve patient data in these physical tests.

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

• Not applicable. The ground truth for these physical tests is based on observable mechanical performance (e.g., does it leak, does it burst at a comparable pressure, does the port break at a comparable force) under controlled laboratory conditions, not expert interpretation of complex data.

4. Adjudication method for the test set:

• Not applicable. Results are objective pass/fail based on predetermined physical thresholds or comparison to a predicate device's physical thresholds.

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:

• Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for the performance tests (Pressure Integrity, Burst, Port Break) is based on objective physical measurements and adherence to predefined engineering specifications or comparison to the physical properties of a predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device.

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The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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.

Model CB511:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda 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.

Model 511T:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Trillium Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The Medtronic Affinity NT Hollow Fiber Oxygenator is a single use gas exchange device with plasma resistant fiber. It is designed to have the blood flow outside the fiber and includes an integral heat exchanger. The oxygenator is available uncoated or bonded on its blood contacting surfaces with either Carmeda BioActive Surface or Trillium Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.

Here's an analysis of the acceptance criteria and study information for the Affinity NT Oxygenator based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each specific bench test performed. It refers to "bench testing" and "real-time aging testing" but does not quantify the number of devices or data points used for these tests.

• Data Provenance: The studies were conducted internally by Medtronic ("Bench testing was used to verify the performance characteristics of this device. In addition, real-time aging testing for devices incorporating the previously implemented changes was completed..."). The country of origin is not specified, but the submitter (Medtronic) is based in Minneapolis, Minnesota, USA. The testing is retrospective in the sense that it's performed on manufactured devices to demonstrate compliance, not prospective clinical trials.

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

This information is not applicable as the document describes bench testing of a medical device (an oxygenator) rather than a diagnostic AI algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests would be the established engineering specifications and performance standards for oxygenators.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Bench testing results are typically objectively measured against predefined specifications, not subject to human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Affinity NT Oxygenator is a physical medical device, not an AI software.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance evaluation of an algorithm was not done. This device is not an AI algorithm. The performance evaluation presented is for the physical device itself.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is engineering specifications and established performance requirements for cardiopulmonary bypass oxygenators. For example, "Demonstrates the devices transfer gas to specification" implies a predefined target range or minimum for gas transfer efficiency. Similarly, "Demonstrates the devices meet Plasma Breakthrough requirements" refers to conforming to a pre-established threshold for plasma leakage.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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