(234 days)
Synapse 3D Perfusion Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals, with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Perfusion Analysis accepts DICOM compliant medical images acquired from CT and MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Base Tools, Synapse 3D Perfusion Analysis provides the parameter images by post-processing of dynamic scanned CT arteriography and magnetic resonance (MR) images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time To Peak (TTP),
Synapse 3D Perfusion Analysis is medical device software for Perfusion Analysis that provides the parameter images by post-processing of dynamic scanned CT arteriography and MR images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time to Peak (TTP). The perfusion parameter images can be presented to the trained medical professionals as the time-density curves (TDC) and perfusion characteristics maps (in parametric and summary) to assist them in assessing the blood flows. Synapse 3D Perfusion Analysis includes the following perfusion analysis applications.
- (1) Brain Perfusion (CT and MR) (unchanged from the FDA-cleared version K120637) is an application that analyzes the cerebral blood flow using the contrast-enhanced dynamic scanned CT and MR cerebral arteriography images. The Brain Perfusion post-processes the cerebral arteriography CT and MR images, and generates the parameter images of Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), MTT, and TTP.
- (2) 4D Perfusion (CT) is an application that analyzes the changes in the cerebral blood flow over time (in 4D) using the contrast-enhanced multi-phase 3D whole-brain images. The 4D Perfusion post-processes the cerebral arteriography CT and MR images, and generates the 4D (over time) parameter images of CBV, CBF, MTT, and TTP.
- (3) Abdominal Perfusion (CT) is an application that analyzes the blood flow of abdominal organs over time (in 4D) using the contrast-enhanced multi-phase 3D abdomen images. The Abdominal Perfusion post-processes the abdominal CT images, and generates the parameter images of Tissue Blood Volume (TBV), Tissue Blood Flow (TBF), MTT, and TTP.
- (4) Cardiac Perfusion (CT) is an application that analyzes the myocardial blood flow using the multi-phase 3D heart images. The Cardiac Perfusion post-processes the contrast-enhanced Myocardial CT images, and generates the parameter images of Myocardial Blood Volume (MBV), Myocardial Blood Flow (MBF), MTT, and TTP.
Synapse 3D Perfusion Analysis runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. Synapse 3D Perfusion Analysis is an optional software module that works with Synapse 3D Base Tools (cleared by CDRH via K120361 on 04/06/2012) which is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices, and it retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools, and the associated image-related information of the image data is registered in the database and is used for display, image processing, analysis, etc. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.
The provided text describes the Fujifilm Synapse 3D Perfusion Analysis device and its 510(k) submission. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Error Rate | The error is within ± 1%. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of cases or patients. The document refers to "all of the test cases" but does not quantify them.
- Data Provenance: "actual clinical images" were used for benchmark performance testing. No specific country of origin or whether it was retrospective or prospective is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The ground truth ("Reference data (Pt)") was derived from a perfusion calculation model using arbitrary CT signal values, not directly from expert consensus on clinical images in the performance testing section.
4. Adjudication method for the test set
Not applicable. The ground truth for performance testing was established computationally through a perfusion calculation model, not through expert adjudication of cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned. The submission focuses on the performance of the algorithm itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance test was done. The "benchmark performance testing" calculated the "Result data (Pc)" by Synapse 3D Perfusion Analysis using input data (Pi) and compared it to "Reference data (Pt)" derived from a perfusion calculation model. This evaluates the algorithm's accuracy in isolation.
7. The type of ground truth used
For the benchmark performance testing, the ground truth (Reference data (Pt)) was derived from a perfusion calculation model using input data (Pi: an image created using an arbitrary CT signal value).
8. The sample size for the training set
Not mentioned in the provided text.
9. How the ground truth for the training set was established
Not mentioned in 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).