Personalized Physiology Analytics Engine software
VGBio, Inc (DBA PhysIQ)The Personalized Physiology Analytics Engine software is a computerized analysis tool designed to monitor changes in a patient's vital signs relationships over time. Using data such as heart rate, respiratory rate, and activity, it calculates a Multivariate Change Index that helps clinicians track significant physiological changes during routine monitoring, aiding in patient assessment but not for direct diagnostic decisions.
Intended Use
The Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. It provides a Multivariate Change Index indicating deviations from a patient's baseline vital signs relationships, for retrospective use by qualified practitioners as an adjunct to monitoring.
Technology
The software analyzes multivariate vital sign data (heart rate, respiratory rate, activity) from existing monitoring devices, learning each patient's personalized baseline based on routine activities. It computes a scalar Multivariate Change Index (MCI) between 0 and 1 to represent how different current vital sign relationships are from baseline, presented as a time series for retrospective review.
Performance
Bench and clinical testing demonstrated the software meets specifications, and that the MCI output correlates with changes in relationships among vital signs compared to baseline. Testing included perturbed clinical data, simulator studies, and healthy volunteer studies with natural physiological perturbations, confirming the device's reliability and safety compared to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/8/2014
9 months - 2
FDA Approval
6/11/2015
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