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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 6 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 Hollow Fiber Oxygenator with Integrated Arterial Filter and Balance Biosurface is a single use, microporous, hollow fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger. The oxygenator is coated on its primary blood contacting surfaces with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function.

The provided document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface. The focus of the submission is on demonstrating substantial equivalence to a predicate device (Affinity NT Oxygenator 511T), rather than establishing de novo performance criteria with a clinical study. Therefore, the information requested regarding acceptance criteria and studies proving the device meets those criteria in the traditional sense of a clinical trial (e.g., sample size for test set, number of experts for ground truth, MRMC studies) is largely not applicable in this context.

Instead, the submission relies on in vitro testing to show that the new device performs comparably to the predicate device and meets established performance specifications and standards for cardiopulmonary bypass oxygenators and arterial bloodline filters.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various in vitro tests conducted. It states that "The Affinity Fusion Oxygenator passed each test mentioned in the table below." This implies that the acceptance criteria for each test were met, demonstrating functional/performance and physical/mechanical characteristics. However, specific numerical acceptance criteria (e.g., "gas transfer efficiency must be >X%") and the exact numerical results obtained ("gas transfer efficiency was Y%") are not provided in this summary.

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

• Sample Size: Not explicitly stated. The tests were "in vitro testing," meaning laboratory bench tests rather than tests on human subjects. The number of devices or test runs for each in vitro test is not specified.
• Data Provenance: In vitro testing, conducted in a laboratory setting. No country of origin for patient data or retrospective/prospective classification is applicable as it's not a clinical study.

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

• Not Applicable. As this was in vitro performance testing against established standards and specifications, there was no "ground truth" established by human experts in the way it would be for diagnostic device evaluation (e.g., radiologists interpreting images). The "ground truth" here is the adherence to performance standards and specifications outlined in the referenced guidance documents and ISO standards.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or adjudication in the context of expert consensus was involved for these in vitro tests. The results were likely measured objectively by instruments and compared against predetermined numerical or pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is relevant for diagnostic imaging devices or algorithms where human readers' performance is being evaluated. The Affinity Fusion Oxygenator is a medical device for cardiopulmonary bypass; therefore, an MRMC study is not applicable.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. This concept applies to AI/software as a medical device. The Affinity Fusion Oxygenator is a physical device, not an algorithm. Its "standalone" performance refers to its operational characteristics during in vitro testing.

7. Type of Ground Truth Used:

• For in vitro testing, the "ground truth" is defined by:
  • Relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff issued on November 13, 2000."
  • ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)."
  • ISO 15675 "Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters."
    The device's performance was measured against the specifications and requirements laid out in these regulatory and international standards.

8. Sample Size for the Training Set:

• Not Applicable. The device did not involve machine learning or an algorithm that required a "training set" of data.

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

• Not Applicable. As there was no training set, this information is not relevant.

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