(57 days)
DynaCAD software consists of the MR Analysis Server software and the viewer workstation software.
The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadman tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and nondynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/ or projected path of the interventional instrument.
The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.
DynaCAD is a software platform for post-processing of MR datasets to provide a reliable means for visualizing MR datasets. It is also designed to provide study review and mathematical and/or statistical analysis. DynaCAD serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. that runs software modules that use algorithms to evaluate MR images as a postprocessing module. The DynaCAD software platform consists of a viewer workstation and the MR Analysis Server. The MR Analysis Server consists of 5 software modules controlled by license keys:
- DynaCAD Breast
- DynaCAD Prostate ●
- PK MR Analysis
- DynaLoc Breast Intervention ●
- DynaLoc Prostate Intervention .
It is used to review, analyze, and generate reports for MRI studies, as well as post-processing of MR raw images directly from the scanner for viewing and analysis. The software facilitates the analysis of dynamic and non-dynamic MR Datasets to provide study review and additional mathematical and statistical analysis. The results can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (P01) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that should be performed to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates smoothly into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician, the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
DynaLOC Breast
The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures.
DynaLOC Prostate
DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and the DynaTRIM Interventional device. The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional or diagnostic procedures of the prostate. The application provides the user with patient data processing, visualization, and storage functions.
PK MRI Analysis
The PK analysis software is designed to allow radiologists to visualize the presence and pattern of contrast induced enhancement for protocols other than Breast and Prostate MR datasets. The option uses the same core processing algorithm contained within All-Time Point pharmacokinetic analysis software, permitting the calculation of Ktrans and Ve values for all voxels within a region of interest in contrast-enhanced MRI studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images.
The provided text describes the DynaCAD software, a post-processing software package for analyzing MR datasets. However, it does not provide specific details about acceptance criteria or a dedicated study proving performance against those criteria.
Instead of a specific performance study, the document mentions adherence to international and FDA-recognized consensus standards for nonclinical testing and performance information.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The text states: "The test results demonstrate that DynaCAD meets the acceptance criteria and is adequate for its intended use." However, the specific quantitative or qualitative acceptance criteria themselves are not detailed in this document. It implies that these criteria are covered within the technical documentation submitted for the 510(k) premarket notification. | The document states: "The test results demonstrate that DynaCAD meets the acceptance criteria and is adequate for its intended use." It also notes that the device adheres to "international and FDA-recognized consensus standards" such as IEC 62304: 2015 Ed 1.1 and ISO 14971:2007. The general performance is described as providing "a reliable means for analyzing MR datasets" and facilitating "analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
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 specified. The document describes DynaCAD as a tool to "assist in the interpretation of dynamic and non-dynamic MR studies" by a "trained physician," but doesn't detail how ground truth was established for testing the software itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 study is explicitly mentioned. The document focuses on the substantial equivalence of DynaCAD to predicate devices based on similar technology, functions, and adherence to standards, rather than comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes DynaCAD as a "post-processing software package" and a "workflow roadmap tool" that "guides the radiologist." This implies a human-in-the-loop system where the software assists the radiologist, rather than a standalone algorithm making diagnoses independently. The nonclinical testing mentioned would likely include software validation of its functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the nature of the software (analysis and workflow guidance), ground truth for its validation would likely relate to the accuracy of its calculations, display of information, and adherence to specified workflows, rather than direct diagnostic accuracy against a histological or outcome ground truth.
8. The sample size for the training set
- Not applicable. DynaCAD is described as a post-processing and workflow tool, not specifically an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. While it uses "algorithms to evaluate MR images," these are likely pre-defined analytical algorithms rather than machine learning models that undergo extensive training.
9. How the ground truth for the training set was established
- Not applicable (as above).
§ 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).