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The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Owlet OSS 3.0-M1 Sensor | Experimental | Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application and monitoring with an Owlet OSS 3.0-M1 Sensor | Device | Owlet OSS 3.0-M1 Sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulse rate accuracy | Average root mean square (ARMS) error between the pulse rate measured by the Owlet OSS 3.0-M1 vs. a reference pulse oximeter | 2 hours |
| SpO2 Accuracy | The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Stratmann, MD, PhD | Vital Signs Research Group, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vital Signs Research Group, LLC | Recruiting | San Francisco | California | 94107 | United States |
Data collected during the course of this study are specifically intended for a regulatory submission and may or may not be shared publicly.
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Prospective study
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| Reference Pulse Oximeter | Device | Application and monitoring with an FDA cleared reference pulse oximeter |
|