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.
Participants must be able to provide informed consent to participate.
Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.
Participants must be 22 to 59 years of age.
Participants or witnesses must be able to read or write in English.
Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a visit 1 and, if applicable, visit 2 positive urine pregnancy test, unless the study participants are known to be not of child-bearing potential .
Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner.
Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
Single group
Device under test evaluation against references
DeviceBlood 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.
Blood pressure mean value of differences
The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-G1-US heart rate determinations and the reference method.
