Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.
For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aktiia.product-G0 device under test | Other | Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device under test evaluation against references | Device | Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references. Device under Test: Aktiia.product-G0 References: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure mean value of differences | The mean value of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements. | 23 hours |
| Blood pressure standard deviation of differences | The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements. | 23 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate root-mean-square error | The root-mean-square difference between the Aktiia.product-G0 heart rate determinations and the reference method. | 23 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parameters Research Laboratory | Broomfield | Colorado | 80021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided