(42 days)
The Synapse 3D Basic Tools Software is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. The Synapse 3D Basic Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, CR, US, NM, PT, and XA, etc.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
The Synapse 3D Basic Tools Software provides several levels of tools to the user:
- Basic imaging tools for general images, such as 2D viewing, volume rendering and 3D volume A viewing, orthogonal / oblique / curved Multi-Planar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, CT PET fusion, surface rendering, sector and rectangular shape MPR image viewing, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, printing, storing, distribution, and general image management and administration tools, etc.
- Tools for regional segmentation of anatomical structures within the image data, path definition a through vascular and other tubular structures, and boundary detection.
The Synapse 3D Basic Tools software offers software tools which can be used by trained professionals, such as radiologists, clinicians or general practitioners to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans. The SYNAPSE 3D Basic Tools software runs on Windows Vista or Windows Server 2008 installed on commercial general-purpose Windowscompatible computers. SYNAPSE 3D Basic Tools is connected through DICOM standard to other medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medial devices. Image data obtained from these devices are used for display, image processing, analysis, etc. SYNAPSE 3D Basic Tools cannot be used to interpret Mammography images.
SYNAPSE 3D Basic Tools can be integrated with Synapse Workstation (cleared by CDRH via K051553 on 07/07/2005) and can be used as a part of a SYNAPSE system.
The provided text describes a 510(k) submission for the FUJIFILM Medical Systems U.S.A. Inc., Synapse 3D Basic Tools. However, it does not contain the detailed information required to fill out a table of acceptance criteria and specific device performance metrics, nor does it describe a study with the specified details.
The document states:
- "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the proposed device."
- "Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process."
- "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed."
This indicates that testing was performed and passed, but the specific acceptance criteria, reported performance values, or details of the study for these performance characteristics are not included in the provided text. The document focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, rather than providing a detailed performance study with quantitative results.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.
§ 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).