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The Affinity Fusion Oxygenator with Integrated Arterial Filter and 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 procedures up to six hours in duration.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active 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 six hours in duration.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Affinity Fusion Oxygenators with Integrated Arterial Filter and with Balance Biosurface or Carmeda BioActive Surface are single-use, microporous, hollow-fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenators are bonded on their primary blood contacting surfaces with either Balance Biosurface or Carmeda BioActive Surface.

The device is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood. The device is also used to cool or warm the blood during routine cardiopulmonary bypass procedures up to six hours in duration. The integrated filter is designed to filter from the extracorporeal circuit microemboli larger than the specified micron size (25u). The filtration functionality is achieved through the progressively tighter fiber spacing within the fiber bundle assembly (FBA) inside the oxygenator.

The purpose of this Special 510(k) Notification was to notify the FDA of an alternate material formulation for the luer caps used on the recirculation, cardioplegia and sampling ports of the Affinity Fusion Oxygenator with Integrated Filter and with either Balance Biosurface or Carmeda BioActive Surface.

This document describes a Special 510(k) Notification for the Medtronic Affinity Fusion Oxygenator with Integrated Arterial Filter, with either Balance™ Biosurface or Carmeda® BioActive Surface. The purpose of this notification is to advise the FDA of an alternate material formulation for the luer caps used on the recirculation, cardioplegia, and sampling ports of the device.

Given that this is a Special 510(k) focusing on a minor material change to luer caps and states that "Clinical testing was not required to establish substantial equivalence," the typical comprehensive device performance study structure (including detailed acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment) is not present in the provided text in the way it would be for a novel device or a significant modification that impacts clinical performance.

However, I can extract the relevant information regarding the performance data that was required and what was concluded regarding substantial equivalence, and then explain why other typical study details are absent.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria for the performance tests in the format of a table with specific thresholds. It confirms that the tests were conducted and the device continued to meet the substantial equivalence requirements.

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

• Sample Size: Not explicitly stated for either biocompatibility or positive pressure integrity tests. The document only mentions that "bench testing was used."
• Data Provenance: The tests were "bench testing," meaning in-vitro, laboratory-based testing conducted by Medtronic. The origin of any specific biological materials (if used in biocompatibility) or external data is not specified. It is prospective testing performed on the modified device.

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

Not applicable. The "ground truth" in this context refers to engineering specifications and regulatory standards for biocompatibility and pressure integrity, not a clinical interpretation by medical experts. These are objective, measurable parameters.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed (biocompatibility, positive pressure integrity) involve objective measurements against established engineering and regulatory requirements, not subjective interpretation requiring an adjudication panel.

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

No. This type of study is conducted for diagnostic or image-interpretation devices to assess human reader performance with and without AI assistance. The Affinity Fusion Oxygenator is a therapeutic device (extracorporeal perfusion circuit component), not an AI-based diagnostic tool.

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

No. This also relates to AI-based diagnostic algorithms. The performance of the oxygenator itself (oxygenation, CO2 removal, heat exchange, filtration) is assessed in a standalone context on the bench, but it's not an algorithm, so the terminology doesn't fit. The "algorithm-only" concept typically refers to the diagnostic output of an AI system without human medical interaction.

7. The Type of Ground Truth Used:

• For Biocompatibility: Established international and national standards for biological evaluation of medical devices (e.g., ISO 10993 series), ensuring the new material does not induce harmful biological responses.
• For Positive Pressure Integrity: Established engineering specifications for the device's structural integrity, ensuring it can withstand operational pressures without leakage or failure.
• For other performance characteristics: Established engineering specifications and performance benchmarks derived from the predicate device's cleared performance, ensuring oxygenation efficiency, CO2 removal rate, heat exchange capabilities, and filtration efficacy remain consistent.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable for the same reason as point 8.

Summary of the Study and Conclusion:

The study described here is a bench-testing verification of a minor material change to a previously cleared medical device (Affinity Fusion Oxygenator). The primary goal was to demonstrate that changing the luer cap material does not adversely affect the device's fundamental performance characteristics, safety, or effectiveness.

The document states:
"Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence."
And
"The following performance tests were conducted:

• Biocompatibility
• Positive pressure integrity"

The conclusion is that:
"In summary, the information included in this submission demonstrates that with changes made to the Affinity Fusion Oxygenators with Integrated Filter and with Balance Biosurface or Carmeda BioActive Surface are substantial equivalent to the legally marketed predicate versions."

This means that the implied acceptance criteria for these tests were successfully met, affirming that the modified device, despite the new luer cap material, maintains the same performance and safety profile as the predicate devices.

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