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510(k) Data Aggregation
(51 days)
vascuCAP
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels. It allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The provided text describes the performance data for the vascuCAP A.1.2 device, comparing it to a predicate device. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as pass/fail thresholds against which the device was evaluated. Instead, it presents "analytic performance metrics" as established results from the testing. For each metric, the reported performance includes bias, intercept, slope, quadratic term, and R^2, along with 95% confidence intervals. The "tested range" indicates the range of true values for the measurand.
Table: Reported Device Performance Metrics (Implicit Acceptance Criteria)
| Structure/Composition | Measurand (Tested Range) | Reported Performance (Point Estimate [95% Confidence Interval]) |
|---|---|---|
| Structure | Lumen Area (0.3 - 290.1mm²) | Bias: 0.81mm² [0.3, 1.9], Intercept: 0.65mm² [-0.6, 0.9], Slope: 1.01 [0.9, 1.0], Quadratic term: 0.0 [0.0, 0.0], R²: 0.9987 |
| Wall Area (9.4 - 448.6mm²) | Bias: 0.50mm² [-1.08, 1.29], Intercept: -0.59mm² [-4.1, 2. 8.0], Slope: 1.0 [0.99, 1.04], Quadratic term: 0.0 [0.0, 0.0], R²: 0.9974 | |
| Stenosis** (33-69%) | Vessels ≥5.9mm: Bias: 3.7% [1.29, 4.47], Intercept: 5.99% [-0.81, 9.93], Slope: 0.96 [0.84, 1.1], Quadratic term: -0.01 [-0.02, 0.01], R²: 0.8034 | |
| **Vessels |
Ask a specific question about this device
(203 days)
vascuCAP
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The provided document is a 510(k) premarket notification letter from the FDA to Elucid Bioimaging, Inc. concerning their device, vascuCAP. While it outlines the device's intended use and the general process of software verification and validation, it does not contain specific details regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment methods, or whether MRMC studies were conducted.
The document indicates that software verification and validation were performed consistent with FDA guidance on "General Principles of Software Validation," and that "Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions." However, it does not present the results of this validation in a quantitative manner or specify the details requested in your prompt.
Therefore, I cannot extract the information required to populate the table or answer the specific questions about the study design and results from the provided text. The document concludes that "vascuCAP is as safe and effective as the predicate device for the intended use" based on this general testing, but the specifics of how that was demonstrated are not included.
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