The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation.
The study is a single center, prospective, non-randomized study to measure the accuracy of an investigational device compared to blood reference values. The design of the study will be conducted in accordance with the recommendations of ISO 80601-2-61:2011 Annex EE.2 Procedure for invasive laboratory testing on healthy volunteers. The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Norbert Device. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3.5 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
Study Type
OBSERVATIONAL
Enrollment
15
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.
SpO2 root mean square accuracy of the Norbert Device
SpO2 root mean square accuracy will be calculated following FDA guidelines.
Time frame: Up to 1 hour
SpO2 bias of the Norbert Device
SpO2 bias calculation of the Norbert Device will follow the FDA guidelines for analyzing population mean bias, between-subject variance, and within-subject variance.
Time frame: Up to 1 hour
Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement
A method comparison study will be analyzed with a Bland-Altman plot. This study will produce limits of agreement (LoA) and associated confidence intervals from the two measurements obtained on each subject. The conclusion that the two measurements are in agreement depends on whether the confidence intervals constructed from the data are within the boundaries set from the maximum allowable difference.
Time frame: Up to 1 hour
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