(20 days)
The vRad Viewer software is used with general purpose computing hardware which meets or exceeds minimum specifications. The vRad Viewer is intended to receive, display, and transmit images for clinical purposes. The vRad Viewer is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with storage components. The vRad Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad Viewer can process medical images from DICOM modalities, such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities.
The vRad Viewer may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and may only be used on monitors determined to be appropriate for the desired task.
The vRad Viewer is a Software as a Medical Device (SaMD) that imports medical data in the Digital Imaging and Communications and Medicine (DICOM) standard from local storage or remote Picture Archiving and Communications System (PACS) sources. The vRad Viewer is a modified version of the Viewer component cleared as part of vRad PACS with Mammography (K162145). Like the Viewer component of the vRad PACS with Mammography device, the vRad Viewer is intended to allow users to visualize, manipulate, and interpret medical images from X-ray radiography, X-ray computed tomography, MRI, ultrasound, nuclear medicine, and other DICOM-compliant modalities on compatible PC workstations. The vRad Viewer is designed to interface with radiologist workflow applications, such as PACS or caching applications, as well as operate as a standalone image viewer.
The vRad Viewer allows users to perform operations related to the manipulation, enhancement, compression, and quantification of medical images at the command of the operator and based on user preferences. Other workflow tools (e.g., Color Map, Window Level Presets, Overlay Display Schemes) exist within the Viewer to allow for operator customization of display and usage preferences.
The Viewer is a Microsoft Windows-based software application that runs on "off-the-shelf" computers that meet the specified minimum basic computer configuration for the Viewer and are running Microsoft Windows 10 Operating System (OS). For operator input and control of the software, standard Microsoft Windows-compatible input devices are used, including keyboards of various configurations, multi-button mice, grips, foot pedal controls, the Contour ShuttlePRO (Jog-Dial), etc. The vRad Viewer is not a hardware device; however, a monitor is required to display images and to interface with the software. Image quality may vary depending on the display monitor, and users must utilize a compatible monitor that meets technical specifications required for the tasks intended to be performed by the user.
The provided text does not contain detailed information about the acceptance criteria and a specific study proving the device meets those criteria. The document is primarily an FDA 510(k) clearance letter and a summary of the device, its intended use, and its equivalence to a predicate device.
The document states that "Software verification and validation testing were conducted" and "Cybersecurity testing for the vRad Viewer was conducted." However, it does not provide specifics on:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance of any test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Results of a multi-reader, multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (e.g., pathology, expert consensus, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing "substantial equivalence" to a predicate device (vRad PACS with Mammography, K162145) based on intended use, principles of operation, and technological characteristics. It mentions that "Any minor differences in technological characteristics do not raise new or different questions regarding its safety and effectiveness when used as labeled. Software and cybersecurity testing demonstrate that the device performs as expected." This indicates that the software was tested to ensure it functions as intended and securely, but the specific performance metrics and studies you've asked for are not detailed in this documentation.
§ 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).