(50 days)
Visualize: Vascular is a software application package. It is designed to view and quantify image data acquired on commercially available ultrasound products. Regions of interest can be segmented, measured and annotated. The results can be displayed in 2D or 3D. The system automatically generates reports of user inputs.
Visualize: Vascular™ 1.0 is a software application designed to assist in visualization, analysis and reporting of ultrasound vascular images. All images acquired for use with Visualize must be obtained using the data acquisition protocol found in the Visualize: Vascular User Guide.
Visualize: Vascular displays cine clips in stack mode, which can be viewed going forward and in reverse. When the user selects a region(s) of interest within the cine clips, Visualize provides a 3D volume reconstruction and surface rendering of the segmented information. The user can manipulate and annotate the 3D reconstructed images. Visualize can also map the cine colour flow information provided by the ultrasound system onto the 3D rendered data. Visualize provides an automated method to measure the narrowest and widest sections of segmented areas.
Visualize: Vascular displays 2D sagittal ultrasound images and provides a manual tool for measurements to be recorded on these 2D images.
The software application automatically generates reports from user inputs annotated during the image analysis process. The user may select the images, measurements and clinical findings to display in the report. All fields may be modified by the user at any time during the analysis and prior to archiving.
An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device.
The Visualize software is a Windows 7, DICOM-compatible platform that may be installed on a standalone PC, PACS, imaging system or embedded in software applications cleared for use in medical imaging. The Medipattern software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM ultrasound equipment manufacturers.
Visualize: Vascular is a software application package. It is designed to view and quantify image data acquired on commercially available ultrasound products. Regions of interest can be segmented, measured and annotated. The results can be displayed in 2D or 3D. The system automatically generates reports of user inputs.
The provided text is a 510(k) summary for the Visualize:Vascular™ device. It describes the device's function and claims substantial equivalence to predicate devices but does not contain specific information about acceptance criteria or a detailed study proving performance. The document largely focuses on regulatory aspects and the general capabilities of the software.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information on a standalone performance study.
- Type of ground truth used (beyond implying user input and clinical findings).
- Sample size for the training set.
- How ground truth for the training set was established.
The document states:
- "Visualize: Vascular has been demonstrated to be as safe and effective as the predicate devices for their intended use."
- "Visualize: Vascular has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices."
These statements indicate that some form of testing was performed to establish equivalence, but the details of this testing, including specific acceptance criteria and performance metrics, are not included in this document. The document essentially states that the device is substantially equivalent to predicates without detailing the specific performance criteria or a study that rigorously proves it meets them.
§ 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).