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The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,

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The provided text is a 510(k) clearance letter from the FDA for a device called the "EP-4 Clinical Stimulator." This document confirms that the FDA has reviewed the premarket notification and found the device to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study designs (like MRMC or standalone studies). This letter is a regulatory approval document, not a clinical study report or a technical performance specification.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text. The requested information would typically be found in a separate submission, such as an engineering report, validation study report, or clinical trial documentation, which is not part of this 510(k) clearance letter.

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