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The AC3™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions:

• 1. Acute Coronary Syndrome
• 2. Cardiac and Non-Cardiac Surgery
• 3. Complications of Heart Failure

The AC3™ Series Intra-Aortic Balloon Pump (IABP) system is a professional use device that provides counterpulsation therapy to adult patients with impaired Left Ventricular (LV) Function. The AC3 Series IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.

The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The IABP delivers helium (He) into the IAB catheter during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes He from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.

The provided text describes a 510(k) submission for the AC3™ Series IABP device and outlines its substantial equivalence to a predicate device. However, the document does not contain information regarding detailed acceptance criteria or the specific study that proves the device meets those criteria in the context of a performance study with human readers or an AI algorithm, as described in the prompt.

The document focuses on demonstrating substantial equivalence through:

• Identical Indications for Use: Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, Complications of Heart Failure.
• Identical Fundamental Technologies, Principles of Operation, and Performance compared to the predicate device (K201112 - AC3™ Series IAB Pump).
• Minor modifications in the subject device, primarily an updated software revision addressing anomalies, an enhancement for disabling data transfer via USB, and other minor reliability/usability changes, along with an alternate SD Card and battery.
• Conclusion based on software verification and validation testing, stating that these tests "raised no new questions of safety or effectiveness and demonstrated that the subject AC3™ IABP is substantially equivalent to the predicate device."

Therefore, I cannot provide the requested information for the following points as they are NOT present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-assisted device. It's for an Intra-Aortic Balloon Pump.
2. Sample size used for the test set and the data provenance: Not applicable in this context.
3. Number of experts and their qualifications for ground truth: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study and effect size: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The provided document is a 510(k) clearance letter for a medical device (Intra-Aortic Balloon Pump), focusing on demonstrating equivalence to an existing device rather than detailing a clinical performance study with AI or human readers. The "software verification and validation testing" mentioned is likely related to the functional integrity and safety of the pump's control system, not a diagnostic accuracy study.

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