(15 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.
The Vitrea Advanced Visualization software 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 Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- Retrieve image data over the network via DICOM
- Display of images in dedicated protocols which are automatically adapted based on exam type
- Select images for closer examination from a gallery of 2D or 3D views
- Interactively manipulate an image in real-time to visualize anatomy and pathology
- Annotate, 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 is a 510(k) summary for Vitrea Advanced Visualization, Version 7.6. This documentation focuses on demonstrating substantial equivalence to a predicate device (Vitrea, Version 7.0 (K150258)) by detailing software changes, intended use, and technological similarities.
Crucially, this document does not describe acceptance criteria for device performance based on clinical outcomes or a study that specifically proves the device meets such criteria. Instead, it discusses:
- Software Verification Testing: This ensures that new features operate according to defined requirements (functional and performance specifications internal to the company for the software itself).
- Risk Management: Assessment of potential harms associated with software modifications and implementation of controls to reduce these risks.
- Compliance with Standards: Adherence to recognized consensus standards like DICOM, ISO 14971, and IEC 62304.
The document explicitly states: "The subject of this 510(k) notification, Vitrea Advanced Visualization software, did not require clinical studies to support safety and effectiveness of the software." This indicates that there are no clinical acceptance criteria or studies providing device performance metrics in the way you've outlined.
Given this, I cannot provide details on your specific requests for acceptance criteria, device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, or training set ground truth. These are typically associated with clinical performance studies, which were not conducted or required for this 510(k) submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the software's functional and technical requirements and the verification testing performed to confirm these requirements are met.
Below is a table summarizing the information that is available regarding the device's assessment, which relates to software functionality and risk, rather than clinical performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria and performance reported here are for software functionality and safety features, not clinical diagnostic performance, as clinical studies were not required or performed for this 510(k) submission.
| Acceptance Criteria Category | "Acceptance Criteria" (as implied by document) | Reported Device Performance (as described in document) |
|---|---|---|
| Software Functionality | New features operate according to defined requirements. | Software verification testing confirmed the software functions according to its requirements. |
| Risk Management | Potential risks are assessed, benefits outweigh residual risk, risks are as low as possible. | Each risk assessed individually; benefits outweigh risk; all risks reduced "as low as possible"; overall residual risk deemed acceptable. |
| Cybersecurity | Adherence to cybersecurity guidance (FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices). | Follows internal documentation based on FDA Guidance; includes hazard analysis, mitigations, controls, traceability, software update plan, integrity controls, and IFU recommendations. |
| Compliance with Standards | Compliance with specified voluntary recognized consensus standards. | Complies with NEMA DICOM (PS 3.1-3.20), AAMI/ANSI/ISO 14971:2007 (Risk Management), and AAMI/ANSI/IEC 62304:2006 (Software Life Cycle Processes). |
| Intended Use Equivalence | Similar intended use to predicate device. | Identical Indications for Use statement as the predicate device (Vitrea, Version 7.0 K150258). |
| Technological Equivalence | Similar principle of operation and technological characteristics to predicate device. | Detailed comparison table shows "Same" across numerous software functionalities (e.g., selection/loading study, visualization, analysis, reporting, DICOM compliance, data security). |
| Safety and Effectiveness Equivalence | Does not raise different questions of safety or effectiveness compared to the predicate device. | Verification/validation testing, risk management, and labeling demonstrate safety and efficacy. Changes do not alter fundamental scientific technology, safety, or intended use. |
2. Sample size used for the test set and the data provenance
Not applicable for clinical performance. For software verification, the "test set" and "data provenance" would refer to the specific test cases and data used for software testing, which are internal to the manufacturer and not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set for diagnostic performance was used.
4. Adjudication method for the test set
Not applicable, as no clinical test set for diagnostic performance was used.
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
Not applicable. The document explicitly states no clinical studies were performed. This device is described as "Radiological Image Processing Software" and not an AI-assisted diagnostic tool that would typically undergo such studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is software for processing and visualization, not a standalone diagnostic algorithm requiring performance evaluation. No clinical studies were done.
7. The type of ground truth used
Not applicable, as no clinical outcome-based ground truth was established. For software verification, "ground truth" implies the expected output or behavior according to the software requirements.
8. The sample size for the training set
Not applicable, as no clinical studies or machine learning model training are described in this 510(k) summary.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned or elaborated upon.
§ 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).