(128 days)
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.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.