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The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system. The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.

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This document is a 510(k) clearance letter from the FDA for the Gereonics Ultra-Piezo Respiratory Effort Sensor. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for a test set.
• Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Information about the training set size or how its ground truth was established.

This type of information would typically be found in the 510(k) submission itself, which is a much more extensive document than this clearance letter. The letter is merely the FDA's formal response indicating approval.

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