(136 days)
Synapse 3D Cardiac Tools 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 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 in Synapse 3D Base Tools, Synapse 3D Cardiac 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 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.
-Coronary artery analysis for MR heart images: which is intended for the qualitative analysis of coronary arteries.
-Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification 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.g. NM image, Bulls eye) and anatomical data.
-Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the valves, measurement of the calcification area in the aorta and the valves. Placement of a virtual prosthetic valve.
-MR parametric maps: which is provided for pixel maps for myocardial MR relaxation times.
Synapse 3D Cardiac Tools (V5.4) is an optional software module that works with Synapse 3D Base Tools (V3.0) (cleared by CDRH via K120361 on 04/06/2012) that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools (V5.4) accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA. The main functions of Synapse 3D Cardiac Tools are shown below.
- Cardiac Function (CT)
- Cardiac Function (MR)
- Coronary Artery Analysis (CT)
- O Calcium Scoring
- Cardiac Fusion
- Coronary Artery Analysis (MR)
- 0 Aortic Valve Analysis
- MR Flow Analysis (MR)
- 4-Chamber Analysis (CT)
- Cardiac Ablation Analysis (CT)
- Cardiac Tx-maps
- Mitral Valve Analysis
Synapse 3D Cardiac Tools runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. It 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 develop treatment plans.
The provided text confirms that the device, Synapse 3D Cardiac Tools (V5.4), was tested for functionality to support its claim of substantial equivalence to its predicate device, Synapse 3D Cardiac Tools (V3.2). However, the document does not provide explicit acceptance criteria in a table format, nor does it detail a specific study with quantitative results to prove the device meets such criteria. It primarily focuses on comparing features and technical characteristics with its predicate and outlines general software development and testing processes.
Here's an attempt to answer your questions based only on the provided text, highlighting what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Cardiac Analysis (CT/MR) | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Coronary Artery Analysis (CT/MR) | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Calcium Scoring | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Cardiac Fusion | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Valve Analysis | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| MR Parametric Maps | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Bulls-eye Display | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Reporting of Results | Not explicitly stated as quantitative acceptance criteria | All tests passed successfully according to design specifications and intended use. |
| Accuracy of (Semi-)Automatic Segmentation, Detection, Registration | Expected accuracy performance | Achieved expected accuracy performance (through benchmark performance testing using actual clinical images). The specific accuracy values or metrics are not provided. |
| System-level Functionality | Pass/Fail criteria based on requirements and intended use | All tests passed successfully. |
| Component Testing | Pass/Fail criteria based on requirements and intended use | All tests passed successfully. |
| Usability Testing | Pass/Fail criteria based on requirements and intended use | All tests passed successfully. |
| Installation/Upgrade Testing | Pass/Fail criteria based on requirements and intended use | All tests passed successfully. |
| Labeling Testing | Pass/Fail criteria based on requirements and intended use | All tests passed successfully. |
| Risk Mitigation Testing | Pass/Fail criteria based on risk management process | All tests passed successfully. |
| Stress Testing | System provides all capabilities necessary to operate according to intended use and substantially equivalent to predicate devices | All components stress tested successfully ensure the system operates as intended and is substantially equivalent. |
| Cybersecurity (Confidentiality, Integrity, Availability) | Maintained in accordance with Section 6 of "Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | Assures an adequate degree of protection for cybersecurity. |
Note: The document describes "benchmark performance testing" for segmentation, detection, and registration, implying a quantitative assessment (achieved "expected accuracy"). However, the specific numerical acceptance criteria or performance metrics are not disclosed in this document. The "All tests passed successfully" statements refer to the system-level validation against general design specifications and intended use, not necessarily against predefined numerical accuracy thresholds for clinical tasks.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "actual clinical images" were used for benchmark performance testing. However, the sample size (number of cases/images) used for any of the testing (system-level, benchmark, etc.) is not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only states "actual clinical images."
3. Number of Experts and Qualifications for Ground Truth
The document states that "Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning." However, it does not specify how many experts were used to establish the ground truth for the test set, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not described in the provided text. The document does not mention any studies evaluating human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The text describes "benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection, and registration functions implemented in Synapse 3D Cardiac Tools achieved the expected accuracy performance." This implies a standalone evaluation of the algorithm's performance for these specific functions. However, the results (e.g., specific accuracy metrics) of this standalone performance are not provided.
7. Type of Ground Truth Used
For the "benchmark performance testing" of segmentation, detection, and registration, it implies a ground truth was used to assess "expected accuracy performance." However, the exact type of ground truth (e.g., expert consensus, pathology, outcome data) is not explicitly stated. It's common in such tools for ground truth to be established by expert manual annotation or consensus, but this is not confirmed in the text.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set, its sample size, or how its ground truth was established. This suggests that the device, or at least the version being evaluated, might be more of a sophisticated image processing and visualization tool with semi-automatic functions rather than a deep learning-based AI device requiring extensive training data in the modern sense. The "benchmark performance testing" focuses on the accuracy of its segmentation, detection, and registration functions, which could be rule-based or model-based, but the origin of any models is not described.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not available 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).