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The Affinity™ Hollow Fiber Membrane Oxygenator Systems are 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.

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This document is an FDA 510(k) clearance letter for a medical device (Affinity™ Hollow Fiber Oxygenator with Trillium™ Biopassive Surface, K973760). It signifies that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, this document does NOT contain information regarding acceptance criteria or a study proving the device meets those criteria. Medical device clearance documents like this typically do not include detailed performance study results or acceptance criteria.

These details would be found in the manufacturer's 510(k) submission to the FDA, which is a much more extensive document that typically includes:

• Detailed descriptions of the device and its intended use.
• Performance data from various tests (e.g., in vitro, animal, and sometimes human clinical studies) to demonstrate substantial equivalence. This data would be compared against the performance of a predicate device or against pre-defined acceptance criteria.
• Risk analysis.
• Labeling information.

Therefore, I cannot provide the requested information based solely on the provided FDA clearance letter. To answer your questions, one would need access to the full 510(k) submission or the underlying studies conducted by AVECOR Cardiovascular, Inc. for the Affinity™ Hollow Fiber Oxygenator.

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The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The AVECOR Cardiovascular Affinity Pump System consists of the Model 2000 Affinity Pump Console, Affinity Pump Rotor, Affinity Pump Holder, Affinity Pump Chamber, 5/8" Connecting Tube and an AVECOR venous reservoir with 5/8" outlet. The AVECOR Affinity Blood Pump Console and components' shall conform with all the applicable requirements of IEC 601, UL 544 and will display the European Community CE marking. The Affinity Pump Console, Model 2000 provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure, timed events and battery status. The AVECOR Affinity Pump has been designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyurethane chamber incorporating polycarbonate inlet and outlet connectors, which fills passively due to the filling pressure exhibited by the fluid height in a reservoir. The peristaltic action of the rollers against the filled pump chamber results in forward flow. Flow rate is affected by the combination of reservoir volume, RPM's of the pump rotor and the total circuit resistance.

This document describes the premarket notification (510(k)) for the AVECOR Affinity Blood Pump System, establishing its substantial equivalence to the Stockert Instrumente (Sorin) Pump System.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the Affinity Blood Pump System was substantial equivalence in performance to the Stockert Instrumente (Sorin) Pump System. This was assessed across various aspects, particularly focusing on blood trauma.

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

The document does not specify the sample sizes for the various tests (In Vitro Operating Characteristics, In Vitro Cellular Damage, etc.) used to establish equivalence. It refers to these details being in other sections/appendices of the 510(k) application.

The data provenance is retrospective, as the tests were conducted by AVECOR to compare their new device against an existing, already marketed predicate device. The country of origin of the data is implicitly the USA, as AVECOR Cardiovascular Inc. is based in Minnesota, and the application is to the US FDA.

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

This type of information is not applicable in this context. The "ground truth" for a medical device's performance in a 510(k) submission for substantial equivalence is typically established by comparing its performance to a predicate device, as opposed to expert consensus on clinical outcomes or diagnoses. The "truth" is whether the new device performs acceptably and similarly to the predicate. The FDA acts as the ultimate arbiter by reviewing the provided data.

4. Adjudication Method for the Test Set

This type of information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials involving expert interpretation of medical images or diagnoses. In this 510(k) submission, the "adjudication" is essentially the review process by the FDA based on the technical and performance data submitted by AVECOR, comparing it against the predicate device.

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

No, an MRMC comparative effectiveness study was not done. This device is a blood pump system, not an AI-assisted diagnostic tool.

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

This concept is not applicable to a mechanical blood pump system. The device itself operates, and its performance is measured directly, not as an algorithm's output for human interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this substantial equivalence determination is the established performance characteristics of the predicate device (Stockert Instrumente (Sorin) Pump System). The new device's performance (e.g., blood trauma, operating characteristics) was tested and compared against the known performance of the predicate. This is a direct comparative performance evaluation against an already approved device.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI-based device that would require training data. The "training" for such a mechanical device involves engineering design, material selection, and iterative physical testing and refinement, not data-driven model training.

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

This information is not applicable for the same reasons as #8.

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The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

The AVECOR MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardion in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

Here's a breakdown of the acceptance criteria and study information for the AVECOR MYOtherm™ XP Cardioplegia Delivery System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number of devices. The study compares the MYOtherm XP Cardioplegia Delivery System to the "similar commercially available MYOtherm Cardioplegia Delivery System." It mentions "Cardioplegia delivery systems of each type were tested." This implies at least one of each type, but likely more for statistical comparison.
   • Data Provenance: The blood trauma study involved in vitro perfusion using "fresh heparinized bovine blood." This indicates the data is from an in vitro laboratory setting rather than human clinical data, and the origin of the blood is bovine. The effectiveness tests (heat exchanger, pressure drop, etc.) were laboratory tests on the device itself.

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

   • This information is not provided in the given text. The studies described are in vitro and engineering performance tests on the device itself, rather than human diagnostic performance studies that would typically require expert ground truth. The "ground truth" for blood trauma was measured directly (platelet/WBC depletion, plasma hemoglobin). The "ground truth" for effectiveness was based on engineered performance metrics.

3. Adjudication method for the test set:

   • This information is not applicable and therefore not provided in the text. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical outcomes where discrepancies among experts need resolution. The studies described are objective measurements of device performance.

4. 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:

   • This information is not applicable and therefore not provided in the text. MRMC studies are relevant for evaluating AI's impact on human diagnostic performance. This submission is for a medical device (cardioplegia delivery system), not an AI diagnostic tool.

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

   • This information is not applicable and therefore not provided in the text. This is a medical device, not a software algorithm or AI. The performance tests (blood trauma, heat exchanger, etc.) are inherently "standalone" in the sense that they measure the device's intrinsic function without human intervention in the measurement process itself.

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

   • Blood Trauma Study: The "ground truth" was established by direct quantitative measurements of blood parameters: platelet counts, white blood cell counts, and plasma hemoglobin levels. This is an objective, laboratory-derived ground truth.
   • Effectiveness Studies: The "ground truth" for heat exchanger performance, pressure drop, gross air management, and structural integrity was established against predefined functional requirements and engineering specifications for a cardioplegia delivery system. This is an objective, engineering-based ground truth.

7. The sample size for the training set:

   • This information is not applicable and therefore not provided in the text. This is a traditional medical device, not a machine learning model that requires a "training set."

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

   • This information is not applicable and therefore not provided in the text for the same reason as above.

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