EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Overview

Development stage

DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

High-impact designation

High-impactSource: a) High-impact

Impact justification

Not reported

Start date

Not reported

Withheld from public reporting

Not reported

Mission

Topic area

Health and Medical

Operational functions

Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

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.

Expected benefits

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.

System outputs

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.

Technology

AI classification

Computer visionSource: Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

System name(s)

Not reported

Custom-developed code

No

Public source code

Not reported

Sourcing

How it was built

Purchased from vendorSource: a) Purchased from a vendor

Vendor (as reported)

Not reported

Vendors (standardized)

None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII

Not reported

Privacy Impact Assessment

Not reported

Authorization to Operate

Not reported

Demographic features

Not reported

Training and evaluation data

Not reported

Federal Data Catalog

Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Potential impacts and how they were identified

Not reported