VA · VA-24-4689 · record R2275

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Department of Veterans Affairs · VHA: Veterans Health Administration

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

With the Ultreon 1.0 software application, these systems perform Optical Coherence Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest physiological waveforms are also measured by the system to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure). The physician may use the resting full-cycle ratio (RFR) or fractional flow reserve (FFR) parameter, along with the knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.

Expected benefits

Support coronary artery scans.

System outputs

Displays measurements of interest.

Technology

AI classification: Classical / predictive MLSource: Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relatio…
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.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported