(15 days)
Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologista, technologists and clinicians.
Obliquus is an integrated Maximum Intensity Projection (MIP) and Multi-Planar Reformatting (MPR) software package intended to be used with Fuji Synapse Workstation Software Version 3.1.1 and higher. This software is designed to be used by radiologists, clinicians and referring physicians to acquire, process, review, store, print and distribute DICOM compliant image studies utilizing standard PC hardware. Obliquus offers similar user interface and image manipulation functionality as was cleared in Synapse Workstation software version 3.1.0.
The Obliquus software enables the user to display MPR visualization of CT or MRI studies in Synapse. Once opened in Synapse, the images can be presented in the following viewers:
MPR Viewer: Visualizes a study image of the selected series in the following four types of plane images:
(1) Original view is the original CT or MRI study image.
(2) Reformatted A view represents visualization of the original view orthogonal to the original study plane (i.e., if original image is axial, then Reformatted A will be of the coronal plane).
(3) Reformatted B view represents visualization of the original view orthogonal to the original study plane (i.e., if the original image is axial, then Reformatted B will be of the sagittal plane).
(4) Oblique view shows a plane image from any direction specified by the user.
Compare Viewer: Compare viewer consists of four windows and up to four series that can be displayed for visual comparison. The Compare viewer functions are as follows:
- . Synchronously display images of each series
- Make synchronous display setting which includes adjusting slice position and changing . synchro unit
- . Switch among 3 orthogonal plane images
- Set rendering mode and slab thickness .
- Display patient study and image information .
- . Toggle with the MPR viewer
Stereo Viewer: Presents images for stereopsis, particularly for Magnetic Resonance Angiography (MRA) MIP images. The Stereo viewer's functions include:
- . Rotating and displaying plane images horizontally
- . Setting image display format
- . Setting rendering mode, slab thickness and projection angle interval
- . Display patient, study and image information
- . Toggle with the MPR viewer
Images can be saved either as bitmap files or to the Synapse server.
The provided text is a 510(k) summary for the FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D MIP/MPR Image Visualization Software OBLIQUUS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically understood for performance metrics like accuracy, sensitivity, or specificity.
The document focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study with quantitative metrics. The "Testing" section broadly refers to "Functional testing" as part of the product development process, but provides no specifics on methodology, results, or acceptance criteria.
Therefore, for the requested information, many fields will be marked as "Not provided in the document."
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not specified. | Not specified. | The document states "Functional testing is a part of the Product Development process" but does not detail specific acceptance criteria (e.g., accuracy, precision) or quantitative performance results for the device's image visualization capabilities. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document. The document mentions "CT or MRI studies" as input for the software but does not specify the origin or nature of the data used for any testing.
- Retrospective or Prospective: Not provided in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of experts: Not provided in the document.
- Qualifications of experts: Not provided in the document.
As there is no detailed performance study described for the device's visualization capabilities, the concept of "ground truth" and expert adjudication in the context of diagnostic accuracy, which these questions imply, is not applicable or detailed in this 510(k) summary. The summary focuses on functional equivalence to a predicate device for image display and manipulation.
4. Adjudication Method for the Test Set
- Adjudication method: Not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs. Without AI Assistance
- MRMC study done: No. This document describes an image visualization software, not an AI software intended to assist human readers in a diagnostic capacity or a comparative effectiveness study of its impact on reader performance.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable/Not provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- Standalone study done: Not explicitly described in the context of performance metrics for image visualization. The "Testing" section refers to "Functional testing" but doesn't detail a standalone performance study with specific outcomes. The device itself is an "Image Visualization Software," implying human interaction is integral to its intended use, rather than an autonomous algorithm making diagnoses.
7. The Type of Ground Truth Used
- Type of ground truth: Not provided in the document. (Given the nature of the device as image visualization software, "ground truth" in the diagnostic sense is not the primary focus of this submission, which emphasizes functional equivalence).
8. The Sample Size for the Training Set
- Sample size for training set: Not applicable/Not provided. This software is described as an image visualization tool, not a machine learning or AI-based diagnostic tool that would typically involve a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
- How ground truth for training set was established: Not applicable/Not provided. (See point 8).
§ 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).