This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
200
Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references. Main references: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.
Parameters Research Laboratory
Broomfield, Colorado, United States
RECRUITINGBlood pressure mean value of differences
The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Time frame: 7 days
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Time frame: 7 days
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-G1-US heart rate determinations and the reference method.
Time frame: 7 days
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