(51 days)
Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data.
lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care.
Key features:
General Viewing:
- · Linked 2D, MPR and 4D viewers for single and multi-study comparison
- · Creation of retrievable evidence and snapshots
- · User defined flexible display protocols
Access to Advanced Applications and Workflows:
- In application access to MR Stitching application
- · Evidence creation and sharing across workflows
General Image Display, Manipulation, and Analysis Tools:
- · Maximum and Minimum Intensity Projection (MIP/MinIP)
- · Identification and Display of Regions of Interest (ROIs)
- · CINE image display
- · Multi-frame display
- · Color image display
- . Simultaneous multiple studies review
- · Cross-reference lines support
- Display of selected images, series, or entire study .
- · Comparison of multiple series or studies
- · Scroll
- Pan
- Zoom
- · Focus
- · Flip (Vertically, horizontally)
- Invert
- · Rotate (Clockwise, counter-clockwise)
- · Arrow
- · Adjust Registration
- · Auto window level/width setting
- · Text/Arrow annotation (Label)
- · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI
Specialized Tools:
- · Image subtraction of two series/datasets
- · Access to semi-automated image stitching
- Study and series linking .
- · Register two different series or groups that do not share a frame of reference to link them spatially
The Multi Modality Viewer is a software application for examining and manipulating medical images from MRI and CT scanners.
It is considered substantially equivalent to its predicate device, the MR Core Software (K151115), which only handled MRI images, and a reference device, Softread Software (K040305), which supports both CT and MRI.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or a specific performance study comparison table for the Multi Modality Viewer beyond feature-by-feature comparison with predicate/reference devices. Instead, it focuses on demonstrating that the device has similar technological characteristics, intended use, and indications for use, and that verification and validation testing confirms its safety and effectiveness.
The document primarily performs a feature-by-feature comparison to establish substantial equivalence.
| Criteria (for comparison/equivalence) | Subject Device: Multi Modality Viewer | Predicate Device: MR Core Software (K151115) | Reference Device: Softread (K040305) | Reported Performance (or comparison outcome) |
|---|---|---|---|---|
| Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | N/A | Same |
| Regulatory Number | 892.2050 | 892.2050 | N/A | Same |
| Product Code | LLZ | LLZ | N/A | Same |
| Classification | Class II | Class II | N/A | Same |
| Review Panel | Radiology | Radiology | N/A | Same |
| Indications for Use | Examines/manipulates MRI and CT images; compares multiple series side-by-side. | Examines/manipulates MRI images; compares multiple series side-by-side. | N/A | Added CT support compared to predicate; similar to reference. |
| Intended Users | Radiologists, Clinicians, Technologists | Radiologists, Clinicians, Technologists | N/A | Same |
| Patient Population | Not applicable (viewer software) | Not applicable (viewer software) | N/A | Same |
| Modality Support | CT and MRI | MRI | CT and MRI | Added CT support compared to predicate; same as reference. |
| DICOM Image Communication | Yes | Yes | Yes | Same |
| 2D Image Review | Yes | Yes | Yes | Same |
| 2D Comparative Review | Yes | Yes | Yes | Same |
| Multi-Planner Reformatting | Yes | Yes | Yes | Same |
| MIP/MinIP | Yes | Yes | Yes | Same |
| Image Editing, Setting, Saving | Yes | Yes | Yes | Same |
| Annotation & Tagging Tools | Yes | Yes | Yes | Same |
| Display Options (e.g., thickness) | Yes | Yes | Yes | Same |
| Quantitative Measurements | Yes | Yes | Yes | Same |
| Snapshot | Yes | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Yes | Same |
| Color Image Display | Yes | Yes | Yes | Same |
| Simultaneous Multiple Studies Review | Yes | Yes | Yes | Same |
| Cross-reference Lines Support | Yes | Yes | Yes | Same |
| Display of Selected Images/Series/Study | Yes | Yes | Yes | Same |
| Comparison of Multiple Series/Studies | Yes | Yes | Yes | Same |
| Scroll Image | Yes | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Yes | Same |
| Pan Image | Yes | Yes | Yes | Same |
| Focus Image | Yes | Yes | Yes | Same |
| Rotate Image | Yes | Yes | Yes | Same |
| Flip Image - Vertical | Yes | Yes | Yes | Same |
| Flip Image - Horizontal | Yes | Yes | Yes | Same |
| Rotate Image - Clockwise | Yes | Yes | Yes | Same |
| Rotate Image - Counter-clockwise | Yes | Yes | Yes | Same |
| Invert Image | Yes | Yes | Yes | Same |
| Arrow | Yes | Yes | Yes | Same |
| Auto Window Level/Width Setting | Yes | Yes | Yes | Same |
| Measurement of Distance | Yes | Yes | Yes | Same |
| Measurement of Angle | Yes | Yes | Yes | Same |
| Measurement of Cobb Angle | Yes | Yes | Yes | Same |
| Identification & Display of Ellipse ROIs | Yes | Yes | Yes | Same |
| Identification & Display of Freehand ROIs | Yes | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Yes | Same |
| Image Subtraction of two series/datasets | Yes | Yes | Yes | Same |
| Study and Series Linking | Yes | Yes | Yes | Same |
| Semi-automated Image Stitching | Yes | Yes | Yes | Same |
| Time Intensity Analysis | Yes | Yes | N/A (not listed for Softread) | Same (comparison with predicate) |
| Batch Save of MPR reformats | Yes | Yes | N/A (not listed for Softread) | Same (comparison with predicate) |
Overall Conclusion: The device is considered substantially equivalent because the added CT modality feature is similar to the reference device and does not raise different questions of safety and effectiveness. The verification and validation testing performed "demonstrate the subject device is as safe and effective as the predicate and reference devices."
2. Sample Size for Test Set and Data Provenance
The document mentions "Verification of the software that included performance and safety testing" and "Validation of the software that included simulated usability testing by experienced professionals." However, it does not specify the sample size used for any test set or the country of origin of the data, nor whether it was retrospective or prospective. The information provided is high-level about the testing processes.
3. Number of Experts Used to Establish Ground Truth and Qualifications
For the "External Validation" mentioned under the "Validation" section, "experienced medical professionals evaluated the application." However, the exact number of experts and their specific qualifications (e.g., radiologist with 10 years of experience) are not specified.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set. It only states that "All validators confirmed that the Multi Modality Viewer software fulfills its intended use."
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study and therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. This device is a viewer, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.
6. Standalone (Algorithm Only) Performance Study
The primary evaluation appears to be of the software's functionality as a viewer, not as an algorithm performing a specific diagnostic task in standalone mode. Verification and validation tests were conducted to confirm proper function of the device's features, but no standalone performance study measuring diagnostic accuracy or similar metrics for an algorithm without human-in-the-loop was reported.
7. Type of Ground Truth Used
The document indicates that "simulation usability testing by experienced professionals" and "workflow testing" were conducted, with "validators confirmed that the Multi Modality Viewer software fulfills its intended use." This suggests "expert consensus" on usability and fulfillment of intended use as the form of "ground truth" or validation outcome, rather than pathology, outcomes data, or a specific diagnostic ground truth, as the device is a viewing platform.
8. Sample Size for the Training Set
The document does not refer to a "training set" because the Multi Modality Viewer is described as a software application for viewing and manipulating images, not an AI/ML algorithm that requires a training set for model development.
9. How Ground Truth for Training Set Was Established
Since there is no mention of a training set, the method for establishing ground truth for a training set is not applicable or discussed.
§ 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).