(80 days)
Vitrea2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
Cardiac Functional Analysis (CFA)
The CT CFA option is intended to be used with CT studies of the heart to assist cardiologists in evaluating heart and left ventricle function when producing a cardiac evaluation. The CFA option includes semi-automatic heart and left ventricle segmentation, including identification of long and short axes across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.
Coronary Artery Analysis
The separately-licensed CT Coronary Artery Analysis, which is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen boundaries, obtain measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.
CT Colonography
The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatted images, supine and prone images, and transparent wall view.
Vessel Probe
The separately-licensed general Vessel Probe option is intended for determining the presence and extent of peripheral vascular obstructive disease by providing a non-invasive survey of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Crosssectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on a ratio of the largest diameter. In addition, clinicians can manually edit the centerline in standard curved MPR views and examine Houndsfield unit or signal intensity statistics.
VScore
The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
The Vitrea2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- Retrieve image data over the network via DICOM .
- Display images that are automatically adapted to exam type via dedicated protocols .
- Select images for closer examination from a gallery of up to six 2D or 3D views .
- Interactively manipulate an image in real-time to visualize anatomy and pathology .
- Annotate, tag, measure, and record selected views .
- Output selected views to standard film or paper printers, or post a report to an Intranet . Output oblooks export views to another DICOM device
- Retrieve reports that are archived on a Web server .
The provided text is a 510(k) summary for the Vitrea2, Version 3.8 Medical Image Processing Software. It outlines the device's intended use, comparison to a predicate device, and a summary of studies performed for regulatory submission.
However, the document does not contain specific acceptance criteria or detailed study results that prove the device meets such criteria. The "Summary of Studies" section only broadly states that the software was "designed, developed, tested, and validated according to written procedures" and that "integration testing/verification testing" and "Beta testing/validation will be successfully completed prior to release." It also mentions a Risk Management Plan.
Therefore, I cannot populate the table or answer many of the specific questions about acceptance criteria and study details. I will indicate where this information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
Information Missing: The document does not provide a table of acceptance criteria or specific reported device performance metrics. The submission focuses on substantial equivalence to a predicate device rather than presenting detailed performance data against predefined criteria.
2. Sample Size Used for the Test Set and Data Provenance
Information Missing: The document does not specify any sample sizes for a test set or the provenance of any data used for testing (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Information Missing: Since specific studies with ground truth establishment are not detailed, there is no information on the number of experts or their qualifications.
4. Adjudication Method for the Test Set
Information Missing: No adjudication method is mentioned as specific test sets and ground truth establishment details are absent.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Information Missing: The document does not mention any MRMC comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. The Vitrea2 system is described as a medical image processing software, and the document doesn't explicitly frame its capabilities as "AI assistance" to human readers in the context of a comparative effectiveness study.
6. Standalone (Algorithm Only) Performance Study
Information Missing: While the device is a software system, the submission does not detail any standalone performance studies where the algorithm's performance is evaluated independently of human interaction against specific metrics. The focus is on the system aiding clinicians in their analysis (human-in-the-loop).
7. Type of Ground Truth Used
Information Missing: The document does not specify the type of ground truth used for any testing.
8. Sample Size for the Training Set
Information Missing: The document does not mention a training set or its sample size. This type of detail is often associated with machine learning or AI-driven systems, which, while Vitrea2 processes images, is not explicitly detailed as having a 'training set' in this 2005 submission.
9. How Ground Truth for the Training Set Was Established
Information Missing: As no training set is mentioned, there is no information on how its ground truth would have been established.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).