(14 days)
Vitrea 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. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indications:
Cardiac EP Planning is a post-processing advanced visualization that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite® System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.
The SUREPlaque™ software application is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. This software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
The Vessel Probe option is intended for viewing the anatomy and pathology 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. Cross-sectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The Vitrea 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 Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea system 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 . Web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server .
The provided document, K071331 for Vitrea®, Version 4.0 Medical Image Processing Software, does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and a specific study proving it.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
No specific acceptance criteria or reported device performance metrics are provided in the document. The document states that the software "will successfully complete integration testing/verification testing prior to Beta validation" and "Software Beta testing/validation will be successfully completed prior to release," but it doesn't specify what those "successful" criteria are (e.g., minimum accuracy rates, precision, etc.) for its various functions (Cardiac EP Planning, SUREPlaque, Vessel Probe).
Study Details
Given the lack of a specific study to prove acceptance criteria, most of these questions cannot be answered.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The intended use for several features (Cardiac EP Planning, SUREPlaque, Vessel Probe) implicitly involves trained physicians for analysis and assessment, suggesting a human-in-the-loop scenario.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary of Findings from the Document:
The K071331 submission for Vitrea®, Version 4.0 is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate substantial equivalence to a currently marketed predicate device, rather than to independently establish the safety and effectiveness of the new device through extensive clinical trials with predefined acceptance criteria.
The document states:
- "The software utilized was designed, developed, tested, and validated according to written procedures."
- "The Vitrea, Version 4.0 system will successfully complete integration testing/verification testing prior to Beta validation."
- "Software Beta testing/validation will be successfully completed prior to release."
- "The Vitrea, Version 4.0 system has similar intended uses as the predicate devices and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea, Version 4.0 system is substantially equivalent to the predicate devices."
This indicates that internal testing and validation were performed, but the details of these tests, including specific acceptance criteria, sample sizes, ground truth establishment, or clinical performance metrics, are not included in this publicly available 510(k) summary. These details would typically be found in the full 510(k) submission, which is not usually made public in its entirety.
§ 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).