Search Results

VesselIQ Xpress is an optional, non-invasive, optimized, post-processing application intended to provide images and tools to analyze vascular anatomy and pathology, aiding physicians in diagnosis and determination of treatment paths, from a set of Computed Tomography (CT) Angiographic images.

VesselIQ Xpress is an option for the Advantage Workstation (AW) platform, CT Scanner, and/or PACS, which can be used in the analysis of 2D and 3D CT Angiography images/data for the purpose of cardiovascular and vascular disease assessment. This software-only device is designed to support physician assessment for a wide variety of clinical uses such as stenosis analysis, pre/post stent planning, pre/post valve replacement planning, and directional vessel tortuosity visualization.

VesselIQ Xpress' automatic visualization tools provide users the capability to segment bony structures for accurate identification of the vessels. Additional tools enable analysis of the vascular anatomy including the aorta, valves, and branching vessels for: anatomical sizing; density and volume analysis of segmented vasculature and calcified / non-calcified plaque; and measurements of abnormalities

The TAVI Analysis option for VessellQ Xpress is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aorta and displays the aortic valve in multiple views for measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to aid in evaluation of appropriate access pathways for interventional procedure planning.

VesselIQ Xpress:
CT Advanced vessel analysis is a post processing analysis software package designed to assist physicians in the evaluation and assessment of vascular anatomy.

VesselIQ Xpress is a software post-processing package for the Advantage. Workstation (AW) platform, CT scanners and PACS reading stations. It is an additional tool for the analysis of 2D & 3D CT angiographic images. It provides and facilitates generating a variety of displays, measurements and batch filming/archive features to study user-selected vasculature which include but are not limited to stenosis analysis, thrombus, pre/post stent planning procedures, pre/post valve planning procedures and directional vessel tortuosity visualization.

TAVI Analysis Option in VesselIQ Xpress:
TAVI Analysis is a post-processing software package for the Advantage Workstation (AW) and AW Server platforms. It is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aorta and displays the aortic valve in multiple views for quick and easy measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to help evaluate appropriate access pathways and can communicate directly with the interventional suite.

FlightPlan for EVAR Option in VesselIQ Xpress:
FlightPlan for EVAR is a post-processing software package for the Advantage Workstation (AW) and AW Server platforms. It is a planning tool used for Endovascular Aneurysm Repair (EVAR) procedures. The software helps to visualize the vascular anatomy, perform key anatomical measurements, choose the treatment strategy, size the endograft and save key information that can be used during the intervention.

Here's a breakdown of the acceptance criteria and study information for VesselIQ Xpress, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format for specific metrics. Instead, it relies on demonstrating high correlations and agreement with manual measurements, which is considered the "reference standard" or "current routine practice."

Study Details

2. Sample Size and Data Provenance for Test Set

• Sample Size: 80 patients
• Data Provenance: Retrospective, from patients who underwent successful TAVI procedures with pre-procedural CT exams. The document doesn't explicitly state the country of origin, but it references "the institution's TAVI planning," suggesting it's from a single clinical site.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three qualified physicians.
• Qualifications: "qualified physicians" and "different experience in cardiovascular CT." No further specific details like years of experience or subspecialty like "radiologist" are provided in the summary.

4. Adjudication Method for Test Set

The document refers to comparing "the mean values of all three readers and comparing to the reference standard" for assessing agreement. This implies some form of consensus or averaging among the three readers was used to establish the "reference standard" or against which the device was compared. It does not specify a formal 2+1 or 3+1 adjudication process where disagreements are resolved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: Yes, the study compared "manual measurements by the predicate" with "semi-automated measurements by TAVI software for aortic annulus assessment in terms of measurement agreement and time spent on tasks among different operators with different experience in cardiovascular CT."
• Effect Size of Human Readers Improvement with AI vs Without AI: The document states that the study compared "time spent on tasks among different operators." While it implies efficiency was a factor evaluated, the summary does not report specific effect size or quantitative improvement in human reader performance with AI assistance (i.e., how much faster or more accurate humans were with the software). It focuses on the agreement and correlation of the measurements themselves.

6. Standalone Performance (Algorithm Only)

The study assessed "semi-automated measurements by TAVI software." This indicates that the software plays a significant role in generating these measurements, potentially with some user interaction for refinement (as implied by "semi-automated"). Therefore, it represents the device's performance in a semi-standalone capacity where it generates the initial measurements that are then compared to manual methods. It's not a purely "algorithm-only" performance if any human input in the measurement process was still involved, but it does evaluate the algorithm's direct output. The summary focuses on comparing the software's measurements to manual ones, rather than comparing human performance assisted by AI versus unassisted human performance, although the latter was implied to be part of the MRMC study.

7. Type of Ground Truth Used

The ground truth was established by expert consensus/manual measurements (manual measurements by the predicate device, which is "routinely used during the institution's TAVI planning"). This is referred to as the "reference standard" against which the TAVI software's measurements were compared.

8. Sample Size for Training Set

The document does not provide information regarding the sample size for the training set. It only describes the clinical study for evaluation of the device.

9. How Ground Truth for Training Set Was Established

The document does not provide information on how the ground truth for any training set (if one was used for model development) was established. It only describes the ground truth for the test set used in the clinical study.

Ask a specific question about this device