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This device can be used for the treatment of: The Sola Counter-Pulsating device is a non invasive external counterpulsation device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction, cardiogenic shock and congestive heart failure.

The Sola Counter-Pulsating device is a non invasive external counterpulsation device.

The provided text is a 510(k) premarket notification approval letter for the "Sola Counter-Pulsating Device." This document approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.

Crucially, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The letter focuses solely on the regulatory approval process, stating that the device is "substantially equivalent" to existing devices for specific indications of use (stable angina pectoris, acute myocardial infarction, cardiogenic shock, and congestive heart failure). Substantial equivalence is a regulatory determination, not a detailed scientific evaluation of performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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