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Esophageal Stethoscope: Monitoring heart and breath sounds.
Esophageal Stethoscope with Electrical Conductors: Monitoring heart and breath sounds, and core temperature.

Disposable Esophageal Stethoscope

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Disposable Esophageal Stethoscope, dated March 19, 1998. This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device's performance evaluation as would be required to answer your request.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (monitoring heart and breath sounds, and core temperature for models with electrical conductors). It does not include a performance study summary or the details of how the substantial equivalence was demonstrated in terms of specific performance metrics.

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