(30 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.
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.
The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea 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 text states that Vitrea, Version 7.0 Medical Image Processing Software, underwent a special 510(k) submission for proposed software changes. The information focuses on demonstrating substantial equivalence to its predicate device (Vitrea, Medical Image Processing Software, Version 4.0, K071331) rather than presenting a performance study with specific acceptance criteria and detailed results for a new medical claim.
Therefore, the document does not contain details about acceptance criteria, a specific study proving the device meets these criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, or ground truth types and training set information.
Instead, the document details:
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Scope of Changes: The document primarily describes changes in the software's components and deployment, such as:
- Replacing/updating product infrastructure components (e.g., "Study Directory" replaced by "Vitrea Client" and "Study List") for better user experience and web-based application support.
- Redesigning the Vitrea Services Platform (VSP) for improved manageability and application integration, with enhanced features like Application Management, User Management, Data Access, System Management, and Workflow.
- Adding a new CPU-based rendering engine to support deployments without GPU hardware, particularly for virtual deployments. The rationale is that this new engine was designed to mirror the behavior of the GPU rendering in both image quality and performance.
- Replacing the DICOM Cache component ("External Communications Framework (ECF)") with "Vitrea Information Management System (VIMS)" and "MINT" for better user experience and improved functionality.
- Adding a new "Multiple User Workstation Deployment" to allow multiple concurrent users access to the workstation without degrading performance.
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Rationale for Changes: Each change is accompanied by a brief rationale, generally related to improving user experience, functionality, manageability, platform support, or deployment capabilities.
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Comparison to Predicate Device: The document extensively compares the modified subject device (Vitrea, Version 7.0) to its predicate device (Vitrea, Version 4.0) across various criteria including device type, common name, regulation, product code, classification, review panel, indications for use, general description, key features, and software functionality. For all these aspects, the comparison column consistently states "Same."
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Absence of Clinical Studies: The "Summary of Clinical Tests" section explicitly states: "The subject of special 510(k) notification, Vitrea software, did not require clinical studies to support safety and effectiveness of the software."
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Non-Clinical Tests: The "Summary of Non-Clinical Tests" mentions that changes were designed and tested according to written procedures including risk management, requirements reviews, code designs, code development testing, code reviews, design reviews, and verification of the software. It states that "The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements." However, specific quantitative acceptance criteria and the performance metrics against those criteria are not provided.
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Cyber and Information Security: Details on confidentiality, integrity, availability, and accountability are provided, indicating compliance with internal security measures and DICOM standards.
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Performance Standards: The device complies with voluntary recognized consensus standards such as NEMA PS 3.1-3.20 (DICOM), ISO 14971:2007 (Risk Management), and IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes).
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Substantial Equivalence Conclusion: The conclusion is that the minor software enhancements do not affect the intended use or alter the fundamental scientific technology, and the modified software has the same indications for use, principle of operation, and performs the same technological functions as the predicate device. The differences are considered "not consequential from the standpoint of device operation, safety, effectiveness or intended use."
In summary, this document is a 510(k) Special submission for software changes, focusing on demonstrating that the modifications do not introduce new questions of safety or effectiveness, and therefore, does not present a performance study with specific acceptance criteria as it would for a novel device or a device with new clinical claims.
§ 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).