|Example use cases||Questions VERIFICATION answer:||Questions ANALYTICAL VALIDATION answer:||Questions CLINICAL VALIDATION answer:|
|Heart rate variability (HRV) from a commercial chest strap||
Is the raw data from the ECG sensor on the commercial chest strap accurate, precise, and consistent?|
Are the processed RR intervals from the ECG sensor and post-processing on-board algorithms accurate with low errors45?
Does the HRV measured from the commercial chest strap ECG sensor provide clinical-grade accuracy of HRV (compared with a traditional ECG and Kubios clinical-grade software45?)|
Does HRV from the commercial chest strap meet standards set by the HRV Task Force46?
Does HRV analysis meet the needs of users using the commercial chest strap (high accuracy under daily activities and during movement)47?
|Can heart rate variability identify the presence of autism spectrum disorder in 8-year-old children48?|
|Gait speed from a commercial accelerometer||
Is the accelerometer sensor accurate and precise within predetermined uncertainty?|
Is the accelerometer sensor raw data uniform and consistent?
|Do the accelerometer sensor and processing algorithms provide clinical-grade accuracy of gait speed (compared to clinical automatic timing system used for gait speed analysis49 under the specific use case the device was developed for)50?||Can gait speed predict the onset of dementia in older adult patients51?|
Is the heart rate sensor (optical heart rate or ECG) accurate, precise, and consistent?|
Does the post-processing algorithm for arrhythmia detection provide high sensitivity and specificity with low errors?
|Does the arrhythmia detector (sensor and algorithms) meet the standards set by the FDA Class II Special Controls Guidance Document: arrhythmia detector and Alarm52? Does the arrhythmia detector provide information consistent with clinical review of ECG53?||Does the product acceptably detect atrial fibrillation (AF) in adults?|
|Closed-loop continuous glucose monitor (CGM)/glucose pump systems||
Is the CGM sensor accurate, precise, and consistent with low errors?|
Is the pump system accurate, precise, and consistent with low errors?
Does the closed-loop feedback algorithm provide timely, accurate feedback from the CGM to the pump consistent with FDA Considerations for Closed-Loop Controlled Medical Devices54?
Does the closed-loop CGM/pump system provide similar accuracy when compared with the current standard (system with multiple devices and manual calibration throughout the day?55)|
Do the closed-loop system components (CGM, pump, and feedback algorithm) meet specifications set by the FDA Regulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care54?
|Does this hybrid closed-loop system acceptably monitor glucose and automatically adjust the delivery of long acting or basal insulin based on the user’s glucose reading in the pre-specified context of use and patient population56?|
|Cuffless blood pressure (CBP) monitoring||
Is the sensor used for CBP monitoring accurate, precise, and consistent with low errors?|
Is the algorithm used for determining BP accurate, precise, and consistent with low errors?
Does CBP monitoring provide clinical-grade accuracy (when compared to a traditional cuff BP monitor)57?|
Does the CBP device meet the standards for wearable devices issued by the Institute of Electrical and Electronics Engineers (IEEE 1708–201457,58) and AAMIA Advancing Safety in Health Technology (ANSI/AAMI/ISO 81060-2:2013)59?
|Do parameters of in-clinic blood pressure monitoring still apply to ambulatory/remotely captured blood pressure when considering the use of blood pressure as a prognostic biomarker for cardiovascular outcomes29?|