EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Description
The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain transthoracic echo (TTE) clinical applications, initially including AutoStrain LV, AutoEF, 2D Auto LV (collectively referred to as “AutoStrain”), and AutoMeasure applications. The R-trigger algorithm is expected to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. The Auto-Measure and AutoStrain features, cleared on Philips EPIQ and Affiniti systems (K211597, K190913 resp.) support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients. The current AutoMeasure and AutoStrain applications require input from physio signal (ECG), using electrodes, because the modules and their detectors work on single cardiac cycles, starting and ending with the End Diastole (ED), or more precisely, with delimiting R-trigger events as a good approximation. Determining the R-triggers is currently done on the EPIQ and Affiniti Ultrasound Systems by a dedicated physio board. To enable clinical users to be able to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, R-trigger feature (non-ECG-based) has been developed.
Detailed example
Automates some routine ultrasound measurements. The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, and Harmonic Imaging.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Accelerate ultrasound workflows: the R-trigger algorithm is expected to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. The Auto-Measure and AutoStrain features, cleared on Philips EPIQ and Affiniti systems (K211597, K190913 resp.) support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients.
Controls / human review
ATO: Not reported; PIA: Not published