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The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing.

The Biological Sound Monitor Sensor is indicated for use with children and adults under the supervision of a physician or other trained health care professional. It is indicated for use during routine exam in clinical or other suitably prescribed environment in conjunction with such devices as an electronic stethoscope.

In no way are any of the sensor functions represented as being in and of themselves diagnostic. Sound signals must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Biological Sound Monitor (BSM) Sensor

This document is a 510(k) clearance letter for the "Biological Sound Monitor (BSM) Sensor". It does not contain information about acceptance criteria or a study proving the device meets them. The document primarily confirms that the FDA finds the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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