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The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IABPs.

This document (K151254/S001) is a 510(k) premarket notification for a modification to an existing device, the CARDIOSAVE Intra-Aortic Balloon Pump. The modification is specifically an "alternative AC/DC Bulk Senior Power Supply with an increased load driving capacity."

Because this is a submission for a minor modification (a Special 510(k)), and not a new device or a significant functional change, there is no AI or software component involved, and therefore no study addressing AI performance. The review focuses on demonstrating that the new power supply does not negatively impact the device's original validated performance.

Therefore, most of the requested information about AI acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document.

However, I can extract information related to the non-clinical tests performed for this specific modification:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in terms of number of units tested. The testing involved compliance with standards and performance/design validation, which typically involves a representative sample of the hardware component.
• Data Provenance: Not applicable as this is hardware testing against engineering standards and requirements, not biological data. The tests were performed by "Datascope Corp." as part of their development process.

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

• Not applicable. This is hardware safety and performance testing against engineering standards, not clinical or diagnostic ground truth establishment by medical experts.

4. Adjudication method for the test set:

• Not applicable. This is hardware safety and performance testing.

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:

• Not applicable. This document refers to a power supply modification, not an AI or software device. There are no human readers or AI involved.

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

• Not applicable. This document refers to a power supply modification, not an AI or algorithm.

7. The type of ground truth used:

• The "ground truth" here is defined by engineering standards (IEC60601-1-2, IEC60601-1) and internal performance specifications for the power supply. The device is expected to meet these predefined technical benchmarks.

8. The sample size for the training set:

• Not applicable. This is hardware testing, not machine learning.

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

• Not applicable. This is hardware testing, not machine learning.

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The CARDIOSAVE™ Intra Aortic Balloon Pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.

The CARDIOSAVE™ Intra-Aortic Balloon Pump (1ABP) is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation.

The provided text describes a 510(k) summary for the CARDIOSAVE™ Intra-Aortic Balloon Pump, focusing on its substantial equivalence to a predicate device (CS300 IABP). The document is a regulatory submission for a medical device that has undergone design modifications.

Crucially, this document states "No clinical evaluation of the modified device was conducted or required." This means that the information you are asking for, which pertains to clinical studies, acceptance criteria for device performance in a clinical setting, and the rigorous testing methodology described in your prompt, is not present in the provided text.

The acceptance criteria listed in the document relate to non-clinical tests and are primarily focused on the development process, such as:

• Requirements specification review
• Hardware and software testing
• Code design and code reviews
• Environmental testing
• Safety testing
• Performance testing
• Hardware and software validation

These are internal development and quality control activities, not performance metrics derived from a human study against established ground truth.

Therefore, I cannot populate the table or answer the specific questions about clinical studies, ground truth establishment, or expert involvement based on the provided text.

The document indicates that the device was deemed "substantially equivalent" based on its technological characteristics and the non-clinical tests performed, and that no clinical data was required for its 510(k) clearance.

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