Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population

Pulse Oximeter Validation

Pulse oximetry, Neonates, Owlet, Accuracy

The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date. The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.

This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate population up to 44 weeks corrected gestational age using convenience sampling of arterial blood gas samples as a part of routine clinical monitoring. The Owlet OSS 3.0 Sensor is the component of the Owlet Dream Sock (DEN220091) and BabySat (K222597), both Food and Drug Administration (FDA) cleared pulse oximeters for infants 1-18 months in 2023. This component performs the signal acquisition and analysis to estimate pulse rate and SpO2 readings. The study will enroll between 20-100 neonates weighing a minimum of 1500g in the hospital setting with available arterial line access and arterial blood gas samples being performed as part of planned patient management. No additional blood gas samples will be taken beyond clinical care indications. The primary outcome of the study is the accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation. Secondary outcomes will include: * Bias in the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as (Owlet OSS 3.0 Sensor SpO2 - SaO2). * Precision of the Owlet OSS 3.0 Sensor SpO2 vs SaO2 defined as ABS (Owlet OSS 3.0 Sensor SpO2 - SaO2). Accuracy will be stratified by a number of demographic elements, including by a 10 point skin tone scale and Individual Typology Angle (ITA) as determined by a spectrophotometer to demonstrate that the sensor technology under test can be accurate across diverse user populations. The primary hypothesis is that the Owlet OSS 3.0 Sensor will measure SpO2 values within +/- 3% ARMS compared to SaO2 measurements. Each study participant will have a total study exposure time of 48 hours. Each participant will be assigned to a unique Owlet device with a specific serial number which will be paired with the study subject identifier. The Owlet OSS 3.0 Sensor will be attached to a study subject's foot and SpO2 readings will be acquired at a set frequency and time-aligned with arterial blood gas sampling performed during the course of routine patient care. Study operators will be blinded to Owlet device readings. Time stamping of Owlet SpO2 readings will be achieved by a prescribed tapping of the device's Base Station which will mark the point at which readings simultaneous to the blood gas sample were recorded. SpO2 readings from the available noninvasive reference pulse oximeter will also be recorded during the time of blood gas sampling to document the subject's baseline SpO2 plateau.

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