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The Eko Electronic Stethoscope System is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

The Eko Electronic Stethoscope System is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

This document is a 510(k) clearance letter for the Eko Electronic Stethoscope System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the letter and the "Indications for Use" statement do not contain information about acceptance criteria or a study proving that the device meets such criteria.

The provided text describes the device's intended use and FDA regulatory information but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Whether a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore,Based on the provided document, I cannot answer your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, neither of which includes the detailed performance study information you've requested.

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