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Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

• Refractory unstable angina
• Impending infarction
• Acute MI
• Refractory ventricular failure
• Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)
• Cardiogenic shock
• Support for diagnostic, percutaneous revascularization, and interventional procedures.
• Ischemia related intractable ventricular arrhythmias ●
• Septic shock
• Intraoperative pulsatile flow generation
• Weaning from bypass
• Cardiac support for non-cardiac surgery
• Prophylactic support in preparation for cardiac surgery
• Post surgical myocardial dysfunction/low cardiac output syndrome
• Myocardial contusion
• Mechanical bridge to other assist devices
• Cardiac support following correction of anatomical defects

Datascope's 8Fr. 50cc Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

The modification to the Datascope's predicate 8Fr. IAB is dimensional only. The modified 8Fr. IAB membrane's volume will increase and the polyimide inner lumen dimension will decrease.

The provided text is for a 510(k) premarket notification for a medical device (Intra-Aortic Balloon Catheter and Accessories). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than the performance of an AI algorithm or a novel medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating AI algorithms or novel diagnostic devices, cannot be found in this document.

The document states that there was "no clinical evaluation of the new device in the U.S." and that non-clinical (in-vitro) tests were conducted to demonstrate comparability to currently marketed devices for functionality and performance.

Here's an explanation of why the specific questions about acceptance criteria and study design are not applicable to the provided text:

• Acceptance Criteria and Reported Device Performance: This document doesn't define quantitative acceptance criteria in terms of clinical performance metrics that would be applicable to AI (e.g., sensitivity, specificity, AUC). It's focused on showing that the modified device (a dimensional change to an existing IAB) is functionally equivalent to existing cleared devices.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These are all concepts relevant to studies that generate new clinical performance data, often for diagnostic devices or AI algorithms. Since no clinical evaluation was performed for this device, these details are absent. The ground truth for training data is also irrelevant here as no AI model is being "trained."
• Training Set Sample Size and Ground Truth Establishment: Again, these are for AI/ML models, not for a device with only dimensional modifications and no clinical testing.

The core of the submission is the claim of "substantial equivalence" based on:

1. Same Intended Use: The device is used for intra-aortic balloon counterpulsation therapy for the same indications as previously cleared Datascope IABs.
2. Technological Characteristics: The modification is described as "dimensional only," increasing the balloon membrane's volume and decreasing the polyimide inner lumen dimension.
3. Non-Clinical Tests: "In-vitro tests" were conducted to demonstrate that the functionality and performance characteristics are "comparable to the currently marketed devices." No specific results from these in-vitro tests are provided, nor are explicit acceptance criteria for these tests.

Therefore, I cannot populate the table or answer the questions as requested based on the given text, because the document describes a 510(k) for a modified medical device with no new clinical data or AI component.

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