(15 days)
Vitrea2 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. In addition, Vitrea2 Version 3.9 has the following additional indication:
The SUREPlaque™ tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
The Vitrea2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 system 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 describes a 510(k) summary for Vitrea2, Version 3.9 Medical Image Processing Software. It outlines the device description, intended use, predicate device comparison, and a summary of studies. However, it does not contain specific details about acceptance criteria, detailed study designs, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test sets, or training set details.
The provided text focuses on regulatory approval and mentions general software design, development, testing, and validation according to written procedures but does not give specific performance metrics or detailed study results.
Therefore, many of the requested fields cannot be populated from the given information.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states that the software was "designed, developed, tested, and validated according to written procedures," and that "Beta testing/validation will be successfully completed prior to Dlease." However, it does not specify what the acceptance criteria for these tests were, nor does it provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) that were met. | Not provided in the document. The document concludes that the device is "substantially equivalent to the predicate devices" and that its changes do not raise "new questions re: safety or effectiveness." This implies that it performs similarly to its predicates, but no quantitative performance data is presented. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: It is not explicitly stated that an MRMC comparative effectiveness study was done. The phrase "assist trained physicians" in the intended use suggests human-in-the-loop, but no study details are provided to confirm an MRMC design or its results.
- Effect Size: Not provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No details are provided regarding a standalone performance study. The "SUREPlaque™ tool kit application software package is intended to assist trained physicians," implying human interaction is part of its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not specified.
Summary of what can be inferred:
- The device is "Vitrea2®, Version 3.9 Medical Image Processing Software" with an additional indication for the "SUREPlaque™ tool kit application software package" to assist in the stratification of patients with coronary disease using multidetector Aquilion CT images.
- The software was designed, developed, tested, and validated according to internal written procedures.
- Beta testing/validation was planned to be completed before release.
- The conclusion is that the device is substantially equivalent to its predicate devices and does not raise new questions of safety or effectiveness.
§ 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).