(17 days)
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting.
VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning.
VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
The Acceptance Criteria and Study for the VitreaView software are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software Functionality | New features operate according to defined requirements. | Test cases were executed against system features and requirements, and the Requirements Traceability Matrix (RTM) was reviewed to ensure coverage. |
| Diagnostic Quality (External Validation) | Resulting image display is of diagnostic quality (brightness, sharpness, artifacts, overall diagnostic quality). | During external validation, experienced radiologists found the display to be of diagnostic quality in all cases. |
| Risk Management | All risks were reduced as low as possible, and the medical benefits outweigh the residual risk (individual and collective). | Each risk was assessed, determined to have a probability of occurrence of harm of "Improbable," and benefits were found to outweigh risks. The overall residual risk was deemed acceptable. |
| Software Verification | Software fully satisfies all expected system requirements and features. | Test cases were executed against the system features and requirements, ensuring RTM coverage. |
| Software Validation | Software conforms to user needs and intended use, and system requirements/features are implemented and met. | Workflow testing was conducted, providing evidence that system requirements and features were implemented, reviewed, and met. |
| Cyber and Information Security | Follows security best practices (OWASP, HIPAA) to limit unauthorized access (User Identification, Automatic logoff, Audit, Data integrity, Authentication, Transport Layer Security, Authentication & Authorization, Access Control, Audit subsystem). | VitreaView implements all listed HIPAA security standards and described security measures (TLS, Active Directory integration, internal database for user passwords, third-party system integration, role-based authorization, site-configurable access control, audit subsystem). |
| Voluntary Recognized Consensus Standards Compliance | Complies with NEMA PS 3.1-3.20 (DICOM), ISO 14971 (Risk Management), and IEC 62304 (Software Life Cycle). | VitreaView software complies with all three listed standards. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the validation by radiologists. It generically refers to "datasets."
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Experienced radiologists" were used. The exact number is not specified.
- Qualifications of Experts: They were "experienced radiologists." Further specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication method for the test set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that "In all cases the radiologists found the display to be of diagnostic quality," implying a consensus or individual judgment without a specific adjudication process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving AI assistance for human readers was mentioned or performed. The device is a medical image viewing and information distribution application, not an AI-powered diagnostic aid that enhances human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device described is a medical image viewer intended for human use and interpretation. There is no mention of a standalone algorithm-only performance assessment. The "external validation" involved human radiologists evaluating the display.
7. The type of ground truth used:
- The ground truth for assessing diagnostic quality was expert consensus/judgment from experienced radiologists. They evaluated "brightness, sharpness, artifacts, and overall diagnostic quality" of the displayed images.
8. The sample size for the training set:
- The document does not describe a training set or a machine learning model that would require one. The VitreaView software is a viewing and information distribution application, and its validation focused on software functionality, risk management, and the diagnostic quality of its image display as perceived by human readers, rather than training an algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is mentioned in the document.
§ 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).