(48 days)
FUJIFILM Synapse PACS Software is intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.
The FUJIFILM Synapse PACS Software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports.
The FUJIFILM Synapse PACS Software 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. It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies.
Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians.
MIP, MPR, and Fusion are not intended for Mammography use. The FUJIFILM Synapse PACS Software may be used to process FUJIFILM's DICOM MG "For Processing" images and also 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 for mammography.
The Synapse PACS which is the subject of this Premarket Notification Submission is a multipurpose, enterprise-wide application intended for communication, storage, display, printing, and processing of medical images. Its software components perform operations related to image manipulation and measurements relevant to radiology and cardiology. As a software-only device, it does not control image acquisition.
Typical users of Synapse PACs are radiologists, cardiologists, technologists, sonographers, technicians, nurses, and clinicians.
The software runs on standard PC equipment using MS Windows operating systems meeting minimum system requirements. An installed Synapse PACS system will typically be comprised of several Synapse PACS clients and one or more Synapse PACS servers
Synapse PACS accepts images and information from any DICOM-compliant acquisition device. In addition to system administrator tools, the device offers additional options for radiologist and cardiologist interpretation, in-house clinical review, and information access including reports, patient status, and clinical information acquired from various medical imaging and information systems.
This document is a 510(k) summary for the FUJIFILM Synapse PACS device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Here's an analysis of the provided text in relation to acceptance criteria and study details:
Overall Conclusion based on the text:
The provided document (510(k) Summary) describes the FUJIFILM Synapse PACS as a Picture Archiving and Communication System (PACS). For devices like PACS, acceptance criteria typically revolve around functionality, performance, and cybersecurity, ensuring the system reliably stores, retrieves, displays, and processes medical images without compromising diagnostic integrity.
However, the provided text does not contain a specific study that quantifies device performance against specific acceptance criteria in the way typically expected for an AI/CADe device (e.g., sensitivity, specificity, AUC). Instead, the document establishes substantial equivalence by demonstrating that the Synapse PACS has the same general intended use, similar indications for use, principles of operation, and technological characteristics as its predicate devices, K160108 (Synapse PACS) and K151859 (Synapse Cardiovascular). The "study" here is primarily a comparative analysis against legally marketed devices, rather than a clinical performance study with predefined acceptance criteria and corresponding metrics.
The statement "Accepted methods for Verification and Validation testing were used for both the current and predicate devices. Software development and testing for both is in compliance with the IEC 62304 'Medical device software – Software life cycle processes' standard" implies that standard software V&V processes were followed, which would include testing against functional and performance specifications. However, the specific results of these tests are not detailed in this summary.
Given this, I will populate the table and answer the questions based on the information that is available in the provided 510(k) summary, and note where information is not present.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Metric (as implied or stated in document) | Performance (as stated in document) | Notes |
|---|---|---|---|
| Functional Equivalence to Predicate Devices | General intended use | Same | Synapse PACS has the same general intended use as predicate devices. |
| Indications for use | Similar | Synapse PACS has similar indications for use as predicate devices. The document indicates specific changes, such as the removal of the ActiveX component, but states these "do not raise issues of safety or effectiveness." | |
| Principles of operation | Similar | Operational principles are similar to predicate devices. | |
| Technological characteristics | Similar | Technological characteristics are similar to predicate devices, including capabilities for image display, analysis (measurements, calculations), and structured reporting across various modalities (X-ray, CT, MR, US, NM). Compatibility with DICOM-compliant images and non-DICOM sources is maintained. Minor technical differences (e.g., ActiveX removal, Google Chrome support) were assessed as not impacting substantial equivalence. | |
| Compliance with Software Standards | Software development and testing | In compliance with IEC 62304 | "Software development and testing for both is in compliance with the IEC 62304 Medical device software – Software life cycle processes' standard." This indicates adherence to established software quality norms, which implicitly includes various forms of testing (e.g., unit, integration, system, regression). However, specific performance metrics from these tests are not provided. |
| Safety and Effectiveness | Differences in features/functionality | Do not raise issues | "Differences in features or functionality do not raise issues of safety or effectiveness." This is a qualitative statement of substantial equivalence rather than a quantitative performance metric. |
| Image Display (Features) | Accusoft Medical Imaging toolkit usage | Used for image processing | The Accusoft toolkit is used for brightness/contrast, enlargement/reduction, and loading of images, as well as saving images in various compression formats (uncompressed, RLE, JPEG Lossless, JPEG Lossy with DCT). The straight copy option is also available. This indicates functional capability. Specific performance metrics (e.g., display speed, accuracy of display) are not provided. |
| Image Quantification (Features) | Measurement capabilities | Full for DICOM-compliant US | Supports 2-D, M-mode, Spectral Doppler, Color Doppler calibration regions, measurements on automatically-magnified images, continuous image overlay of measurements, user-definable measurement parameters/calculations, viewable formulas, automatic image calibration. No specific accuracy metrics (e.g., mean absolute error for measurements) are given. |
| Reporting (Features) | Clinical Reporting Application (CRA) capabilities | Provides structured reporting | CRA offers pre-built, procedure-specific report templates, customization by engineers, and integration with Synapse's clinical context and measurement capabilities. Report Distribution Service (RDS) distributes reports as HL7 results. Specific performance or accuracy of reporting is not detailed. |
Based on the provided text, the following information is NOT available:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not mentioned. The document refers to "Verification and Validation testing" but does not detail any specific test sets, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not mentioned. Since specific test sets are not detailed, there is no information about experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned.
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
- Not done/Not mentioned. This device is a PACS, not an AI/CADe device designed to assist human readers directly in diagnosis to improve their performance. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not described or relevant for this submission type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not mentioned. The Synapse PACS is a system for image management and display, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not mentioned.
8. The sample size for the training set
- Not applicable/Not mentioned. This is a PACS system, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" would be its software development and testing, compliant with IEC 62304.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned. See point 8.
§ 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).