(24 days)
Fuji Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The Fuji Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical Images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities.
The Synapse Workstation may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible, displays. Synapse does not provide spatial frequency enhancement, dynamic range control, or mulli-objective frequency image processing for DICOM MG "For Presentation" mammography images.
The Synapse Workstation provides viewing and manipulation of radiological data including images, reports, patient status, and clinical information.
The workstation utilizes a folder structure providing easy navigation and organization of images, studies, documents, etc. that most users are familiar with from Microsoft Explorer and other Windows applications. The workstation contains workflow scripting and hanging protocols designed to maximize productivity and allow each user to tailor the workstation operation to their individue looging
In addition to common image manipulation functions such as windowlevel and windowlydth variation, magnification, density value, etc., the Synapse Workstation provides more advanced image processing, including processing of CR and CT images.
The provided text is a 510(k) summary for the Fuji Synapse Workstation Software. This type of document focuses on establishing substantial equivalence to predicate devices rather than providing detailed studies proving specific performance metrics against defined acceptance criteria for AI/ML-based devices.
Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, specific studies demonstrating the device meets those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.
The device description primarily highlights its functions for viewing and manipulating radiological data, workflow, and image processing capabilities, comparing them to predicate devices like the Fuji CR Console and Amicas Light Beam Workstation. The "Safety Information" section discusses hazard analysis and compliance with standards like DICOM, but not performance-based acceptance criteria in the context of AI/ML evaluation.
The 510(k) summary concludes with a statement of substantial equivalence to its predicate devices for its intended use, which is typical for a device of this type and era (2005).
§ 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).