(15 days)
Synapse Obliquus MIP/MPR/Fusion software enables the display of 3D (MIP/MPR) visualization of CT, MR and PET studies and fusion or blending of CT and PET studies. Typical users are radiologists, technologists, and clinicians. Obliquus is not intended for mammography use.
Synapse Obliquus MIP/MPR/Fusion Software (this submission) is an upgraded version of the Synapse 3D Visualization Software Obliquus (K061672) with all previous features plus a newly developed Fusion feature. The major change is the addition of Fusion blends images from CT and PET series and displays the blended series using various color tables assigned to one of the two source series. A few improvements have also been made to the functionality cleared in K061672. It will now be possible to add annotations in the MPR viewer and length measurement and ROI measurement functions have been added to Common Image Processing Features (for all Viewers).
The provided text does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the FUJIFILM Medical Systems U.S.A., Inc. Synapse Obliquus MIP/MPR/Fusion software, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance metrics against predefined acceptance criteria from a specific study.
The document highlights:
- Substantial Equivalence: The primary assertion is that the Synapse Obliquus MIP/MPR/Fusion Software is substantially equivalent to a combination of two predicate devices: Synapse 3D (MIP/MPR) Image Visualization Software OBLIQUUS (K061672) and GE Advantage Windows CT/PET Fusion (K010336).
- Added Features: The new device adds a "Fusion" feature for blending CT and PET images and improvements to existing functionalities (annotations in MPR viewer, length measurement, ROI measurement).
- Safety Information: A hazard analysis was conducted, and preventive measures indicate the device is of "moderate concern" according to relevant guidance.
- Conclusion: The submission concludes that the device is "as safe and effective as the predicate devices."
Therefore, it is not possible to complete the requested table and answer the specific study-related questions based on the provided text.
The document discusses the regulatory pathway and rationale for substantial equivalence, but it does not present:
- A table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, processing speed, measurement precision) or reported device performance against such criteria.
- Details about a specific performance study, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth, either for a test set, training set, or an MRMC study.
- Information on standalone algorithm performance or the type of ground truth used in such studies.
The provided text pertains to the regulatory submission process and the determination of substantial equivalence, which often relies on comparison to existing legally marketed devices without necessarily requiring de novo performance studies with pre-defined acceptance criteria for every feature, especially for visualization and image processing software.
§ 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).