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The Medtronic CardioTherm™ Blood Cardioplegia System, with or without Carmeda® BioActive Surface, is intended for use in procedures requiring the mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

The Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is coated with a non-leaching bioactive heparin surface which provides thromboresistant blood contact surfaces. The Carmeda® BioActive Surface is present on blood path materials.

Each Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios depending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient.

The Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda BioActive Surface consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or non-vented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery.

The heat exchanger housing contains non-porous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.

The flow of solution through the Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda® BioActive Surface is as follows:

Blood/Cardioplegia

The blood and/or cardioplegia solution enters the bottom of the device, flows up through the polypropylene hollow fibers, flows back down a center collecting tube, and exits the from the bottom of the device.

Water

The cooling/warming water enters a side port, passes around the outside walls of the polypropylene fibers, then exits through a parallel side port.

Heat exchange occurs as the blood/cardioplegia solution passes through the hollow fibers, while the temperature regulated cooling/warming water passes around the outside walls of the same fibers. The blood/cardioplegia solution is cooled/ warmed as it flows through the heat exchanger.

By connecting tubing of specific inner diameters to the heat exchanger, a predetermined approximate ratio of blood to cardioplegia solution may be delivered to the patient. The tubing sets are equivalent to the tubing sets which are currently used for the CardioTherm™ Blood Cardioplegia System (K960755)

Four of the various delivery ratios available are:

• a tubing set for 1:1 ratio of blood to asanguineous cardioplegia. 1.
• a tubing set for 2:1 ratio of blood to asanguineous cardioplegia. 2.
• a tubing set for 4:1 ratio of blood to asanguineous cardioplegia.
• a tubing set for 9:1 ratio of blood to asanguineous cardioplegia. 4.

These tubing ratios are identical to the commercially available CardioTherm™ Blood Cardioplegia Systems.

The provided text describes a 510(k) premarket notification for the Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove that the device meets specific acceptance criteria through a clinical study with real-world patient data, as would typically be the case for novel AI/ML medical devices.

Instead, the submission focuses on comparing the modified device (with the Carmeda® coating) to existing predicate devices already approved for market, primarily through in-vitro bench testing and biocompatibility testing. The "acceptance criteria" here are implicitly related to demonstrating that the new technological characteristic (the Carmeda® coating) does not negatively affect safety or effectiveness and that the modified device remains substantially equivalent to its predicates.

Therefore, the requested information elements related to clinical studies, human readers, ground truth establishment, and training/test set sample sizes (common for AI/ML device evaluations) are not directly applicable or available in the provided document, as this is a modification to an existing device rather than a de novo submission for a new AI/ML diagnostic or therapeutic device.

Here's an interpretation based on the provided text's context:

Acceptance Criteria and Study Details for Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface

The "acceptance criteria" in this context are not explicit numerical thresholds from a clinical trial, but rather the demonstration of substantial equivalence to predicate devices through various tests. The device is considered to meet these criteria if the performance data from in-vitro bench testing and biocompatibility testing show that the addition of the Carmeda® BioActive Surface does not significantly affect safety and effectiveness compared to the predicate devices.

1. Table of "Acceptance Criteria" and Reported Device Performance

Given that this is a 510(k) for a device modification, the "acceptance criteria" are implied to be comparable performance to the predicate device across key characteristics, and absence of new safety/effectiveness questions. The "reported device performance" refers to the results of the in-vitro bench testing and biocompatibility studies conducted on the CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" here refers to the in-vitro bench tests and biocompatibility tests conducted on the modified device and compared to the predicate. The specific number of devices or test runs for these in-vitro tests is not provided in the summary.
• Data Provenance: The data primarily comes from in-vitro bench testing and biocompatibility testing performed by Medtronic, Inc. It is not patient data from a specific country or retrospective/prospective study in the clinical sense.

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

• Number of Experts: Not applicable. For this type of device modification submission, "ground truth" is established through engineering and scientific test methods (e.g., measuring pressure, analyzing coating, biological compatibility assessments), not through expert clinical consensus on patient cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept applies to expert review of ambiguous clinical cases, which is not relevant for this engineering and biocompatibility assessment.

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

• MRMC Study: No. This type of study assesses the impact of an AI algorithm on human reader performance, which is not relevant for a blood cardioplegia system with a bioactive surface coating.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No. This device is not an algorithm, and the concept of standalone performance does not apply to a physical medical device in this context. The closest analogy would be the in-vitro bench testing evaluating the device's physical and functional characteristics.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on established scientific and engineering measurement standards for device performance (e.g., pressure drop, heat exchange efficiency) and biocompatibility assessment protocols. It is not pathology, expert consensus on patient outcomes, or clinical outcomes data. The acceptance is based on demonstrating that the new coating does not alter these "ground truths" of established performance and safety compared to the predicate.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that undergoes a training phase.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/ML algorithm.

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The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.

The provided document is a 510(k) summary for the Medtronic CardioTherm™ Blood Cardioplegia Delivery Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the manner one might expect for a novel diagnostic or AI-driven device.

Therefore, many of the requested points regarding acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission. This document details a comparison of general characteristics and nominal specifications to establish substantial equivalence.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of defined metrics and thresholds for a specific performance study. Instead, it presents a comparison of the Medtronic CardioTherm™ Blood Cardioplegia System's characteristics and specifications against four predicate devices to demonstrate substantial equivalence. The "performance characteristics" listed are:

The "acceptance criteria" for this type of submission are implicitly that the new device's characteristics and performance are comparable to, or within the established safety and effectiveness profile of, the predicate devices. The document argues that this is the case, stating, "The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are either identical or substantially equivalent to other These predicate/marketed Blood Cardioplegia Systems currently in commercial distribution."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is a comparison of product specifications and intended use, not a clinical trial or performance study on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as there is no mention of a test set requiring expert-established ground truth. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and market history.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no test set or adjudication process described.

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

This information is not applicable. The device described is a medical instrument (blood cardioplegia delivery system), not an AI-driven diagnostic tool. Therefore, there are no "human readers" or AI assistance involved in its function or evaluation in the context of this submission.

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

This information is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices as previously cleared by regulatory bodies. The submission aims to demonstrate that the new device is "substantially equivalent" to these already-marketed devices, implying it meets similar safety and performance standards.

8. The sample size for the training set

This information is not applicable as the device is not an AI system 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 above.

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