Vital Signs

Oxehealth Vital Signs is a software-based system that utilizes fixed optical sensors and proprietary algorithms to noninvasively measure pulse rate via remote photoplethysmography and estimate breathing rate from chest wall movements in video. It is designed for spot-check monitoring of still, adult subjects in non-critical care settings by trained healthcare professionals, with performance validated against clinical reference standards.

Oxehealth Vital Signs is a software-based medical device designed for noninvasive spot measurement of pulse rate and estimated breathing rate. It operates by analyzing video footage captured by a fixed-installation optical sensor (camera) located in a single occupancy room. The system utilizes proprietary algorithms: pulse rate is determined by detecting subtle skin color changes indicative of blood flow (remote photoplethysmography - rPPG), while breathing rate is estimated from subtle chest wall movements visible in the video. The device is intended for use by trained healthcare professionals to monitor adult patients (18 years or older) who are still and do not require critical care or continuous vital signs monitoring. It is designed for environments such as hospitals, general care facilities, and secured settings where periodic health checks are standard practice. The underlying science involves optical sensing and algorithmic interpretation of physiological signals from video. Pulse rate measurement relies on rPPG technology, while breathing rate estimation is based on motion analysis of the chest. The system's performance has been validated through non-clinical software verification and validation, including algorithm performance, usability, and cybersecurity assessments. Clinical validation studies compared its accuracy for pulse rate and breathing rate against recognized reference methods (like pulse oximeters, ECG, manual counts, or capnography) in diverse adult populations within intended use environments, meeting predefined acceptance criteria. It's important to note that this device is not intended to be the sole method for assessing a subject's physical health and is specifically for non-continuous, spot-check measurements when the subject is still.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the validated range of skin tones and lighting conditions under which the rPPG algorithm maintains its stated accuracy for pulse rate measurement?; How does the system differentiate between actual chest wall movements for breathing rate and other body movements, especially in restless but not critically ill subjects?; What are the specific performance metrics (e.g., mean absolute error, limits of agreement) from the clinical validation studies when compared to the reference methods for both pulse rate and breathing rate?; Could the video footage be retrospectively analyzed for other subtle physiological or behavioral markers beyond pulse and breathing rate, and what ethical considerations would this entail?; What is the minimum duration of "stillness" required by the subject for the device to acquire accurate pulse rate and breathing rate measurements?