(126 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, 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 in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom Ul, 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-contrast 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 and quantitative analysis of coronary arteries
- Calcium scoring for non-contrast 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.g. NM image, Bulls eye) and anatomical data.
Synapse 3D Cardiac Tools (V3.0) is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K103465 on 01/31/2011).
Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.
Synapse 3D Cardiac Tools (V3.0) is an application that supports the cardiac function, cardiac fusion, and coronary artery analysis of both the computed tomography (CT) and magnetic resonance (MR) images. Synapse 3D Cardiac Tools also supports the calcium scoring for noncontrast CT images.
The provided text describes the Synapse 3D Cardiac Tools (V3.0) and its substantial equivalence to a predicate device, but it does not include specific acceptance criteria or details of a study (e.g., performance metrics, statistical analysis) that proves the device meets those criteria.
Instead, the document states: "Synapse 3D Cardiac Tools is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Cardiac Tools software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device."
Therefore, I cannot provide the requested table or detailed study information. I can only infer what the general approach to testing was.
Based on the provided text, here is what can be extracted and what information is not available:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Compliance with Software Requirements Specification | Tested successfully |
| Performance characteristics | Established, deemed safe and effective |
| Functionality characteristics | Established, deemed safe and effective |
| Reliability characteristics | Established, deemed safe and effective |
| Substantial equivalence to predicate device (K103465) for cardiac function (CT/MR), coronary artery analysis (CT), calcium scoring, and cardiac fusion | Demonstrated for V3.0 (including new MR Coronary Artery analysis) |
Note: The document only states that testing was "successful" and that characteristics were "established." It does not provide quantitative metrics for device performance against specific targets.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "images acquired from CT and MR" but provides no details on how these images were assembled for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: Not mentioned or implied. The document focuses on the software's functionality and substantial equivalence rather than comparative effectiveness with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: The testing described focuses on the device's adherence to its specifications rather than a specific standalone performance study with defined metrics against a ground truth. The device is a "medical image processing and analysis software" intended to provide "tools to aid them [trained medical professionals] in reading, interpreting, reporting, and treatment planning," suggesting it's designed as an aid, not a standalone diagnostic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not specified. Given the nature of the application (cardiac function, coronary artery analysis, calcium scoring), it would typically involve comparisons to established clinical measurements or expert interpretations, but the document does not elaborate.
8. The sample size for the training set:
- Sample size for training set: Not specified. There is no mention of a "training set" as the device is presented as an updated version of a previously cleared software, implying its development might predate or not entirely rely on modern machine learning training paradigms in the same explicit way.
9. How the ground truth for the training set was established:
- How ground truth was established for training set: Not specified.
In summary: The provided 510(k) summary focuses on the device description, its indications for use, its technological characteristics (primarily stating no new safety/efficacy issues compared to predicates), and that it underwent successful verification and validation against its Software Requirements Specification to demonstrate substantial equivalence. It lacks the detailed performance study information typically found in submissions for AI/ML devices requiring specific performance metrics against a robust ground truth.
§ 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).