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The "Rhythm Digital Electronic Stethoscope" is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering and can be used on any patient undergoing physical assessment. The device can also be used to measure heart rate, based on measurement of heart sound signals.

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The provided text is a 510(k) premarket notification approval letter for the "Rhythm Digital Electronic Stethoscope." It confirms the device's substantial equivalence to predicate devices but does not contain information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance evaluation.

Therefore, I cannot populate the requested table and answer the study-related questions based on this document. The information typically required for these questions (e.g., performance metrics like sensitivity, specificity, or AUC; details of clinical trials; characteristics of the test set) is not present in this regulatory approval letter.

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