(68 days)
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Basic Tools 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. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools with Synapse 3D Basic Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows. custom UI, targeted measurements and reporting functions including:
- Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
- Functional cardiac analysis for non contrasted MR heart images: which is intended to evaluate the functional characteristics of heart
- Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
- Calcium scoring for non contrasted CT heart images: which is intended for non invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
- Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.q. NM imaqe. Bulls eye) and anatomical data.
Synapse 3D Cardiac Tools is with Fujifilm's Synapse 3D Basic Tools (K101662, cleared by CDRH on July 26, 2010) and can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.1.0 and above as a part of a Synapse system. Synapse 3D Cardiac Tools also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.
Synapse 3D Cardiac Tools offers physicians the following clinical applications in addition to the features available from our cleared Synapse 3D Basic Tools (K101662) to analyze the image data retrieved from various connected devices.
Functional cardiac analysis (CT)
Functional cardiac analysis (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, etc.
Functional cardiac analysis (MR)
Functional cardiac analysis (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, output volume per beat, etc.
Coronary artery analysis (CT)
Coronary artery analysis is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.
Calcium Scoring
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.
Cardiac Fusion
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.
I'm sorry, but relevant information specifying the acceptance criteria, study details, and device performance for the Synapse 3D Cardiac Tools is not present in the provided text. The document K103465 mainly provides general information, device description, indications for use, and regulatory correspondence.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- The type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 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).