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The Affinity Fusion Cardiotomy/Venous Reservoir with Baiance Biosurface is intended to be used in an extractivered perfusion circuit to collect venous and canioned blood during routine cardiopulmonary procedures up to 6 hours in duntion. 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 head surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) 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 to the patient for blood volume replacement. The inside of the jar is coated with Balance Biosurface to reduce platelet activation and preserve platelet function.

This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.

Here's a breakdown of the acceptance criteria and study information for the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria:

The document states that the device demonstrated "substantially equivalent" performance to the predicate device and that all tests "Passed." While the specific numerical acceptance criteria values are not explicitly detailed in this summary, the implication of the "Pass" result is that the device met pre-defined, acceptable thresholds for each performance metric, consistent with the predicate device and relevant special controls guidance.

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

The document does not specify the exact sample sizes used for each individual test. It states that "The following verification and validation testing has demonstrated that substantially equivalent to the predicate device."

• Data Provenance: The studies were conducted by Medtronic, Inc. as part of a 510(k) submission. The data is retrospective in the sense that it's being submitted for regulatory approval, but the studies themselves would have been prospective tests undertaken by the manufacturer during product development and validation. No country of origin for data collection is specified, but the applicant is Medtronic, Inc., a US-based company, and the submission is to the FDA.

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

This information is not applicable and not provided. The device is a medical device (cardiotomy/venous reservoir), not an AI/software device that requires expert-established ground truth for its performance metrics (like diagnostic accuracy). The tests conducted are engineering and biocompatibility evaluations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data where consensus among experts is needed to establish ground truth for algorithm comparison. The studies for this device are laboratory/benchtop performance and biocompatibility tests.

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

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. This device is a physical medical device, and its performance is evaluated through engineering and biocompatibility tests, not human interpretation tasks.

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

This information is not applicable and not provided. This device is a physical product (a reservoir), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Pre-defined performance specifications and industry standards: For tests like Blood Damage Testing, Defoaming, Filtration Efficiency, Gaseous Microemboli, Dynamic Holdup, Prime Breakthrough, Static Holdup, Volume Marking Accuracy, Reservoir Capacity, and Particulate Count. These would be established through engineering requirements, regulatory guidance (Special Controls Guidance Document), and comparison to the predicate device.
• Biocompatibility standards: For Cytotoxicity and Hemocompatibility, the ground truth is established by the criteria defined in ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set."

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

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

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The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures.

The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is a hardshell collection reservoir for venous blood and for blood recovered from Cardiotomy ouction room of for renease ices. The blood recovered by intracardiac suction ouslow and venthoular devices enters the reservoir through the top and passes through a filter media. The design of the reservoir is such that if, under normal operating a lume of less than 1000ml and if there is no foaming of the recovered blood, there is no blood contact with the open cell polyurethane defoamer. Venous there to ho blood comugh the top of the reservoir and is mixed with the filtered blood. As with the recovered Cardiotomy blood, under normal operating volume of less than 1000ml if there is no foaming of the venous blood entering the reservoir, there is no blood contact with the defoamer.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K021287 does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., a certain percentage of accuracy, sensitivity, or specificity). Instead, it relies on a determination of "substantial equivalence" to a predicate device.

However, based on the determination of substantial equivalence, we can infer the implicit "acceptance criteria" are that the new device, Trillium™ AFFINITY NT CVR with Filter with Trillium BioPassive Surface, performs at least as safely and effectively as the predicate devices and does not raise new safety or effectiveness concerns.

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

The provided summary does not specify a sample size for a test set in clinical trials or performance studies involving human subjects. The evaluation appears to be based on biocompatibility and in vitro bench testing.

• Sample Size: Not specified for any "test set" in the context of clinical performance. The testing mentioned is "biocompatibility and in vitro bench testing."
• Data Provenance: Not explicitly stated, but the submission is for a US FDA 510(k) clearance, implying the testing was conducted to US regulatory standards. It's likely a combination of preclinical lab studies. The text does not indicate retrospective or prospective clinical data.

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

This information is not applicable or provided in the context of this 510(k) submission. The device is a physical medical device (venous reservoir), not an AI/diagnostic software. Therefore, there's no "ground truth" establishment by experts in the typical diagnostic sense. The "ground truth" for material compatibility and functional performance would be established through established scientific and engineering testing protocols.

4. Adjudication Method for the Test Set

This is not applicable or provided. As stated above, this is a physical medical device, and the evaluation relies on biocompatibility and bench testing, not expert adjudication of diagnostic outcomes.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems where human readers interpret medical images or data. The device in question is a component of an extracorporeal perfusion circuit.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI system was not done. This device is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Established scientific and engineering metrics: For biocompatibility (e.g., cytotoxicity, hemocompatibility, sensitization testing) and in vitro bench testing (e.g., flow rates, filtration efficiency, defoaming effectiveness, structural integrity).
• Comparison to predicate device performance: The "ground truth" for safety and effectiveness is largely anchored to the established performance profile of the predicate devices. If the new device performs equivalently or better in these established tests, it meets the "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable or provided. The device is a physical product, not a machine learning model, so there is no "training set" in this context.

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

This information is not applicable or provided. As there is no training set for a machine learning model, there is no ground truth established for one.

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