(42 days)
CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).
CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MRI guided interventional procedures.
When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream.
CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.
CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
CADstream receives DICOM magnetic resonance images from a PACS of directly from the MRI scanner. As they are received, CADstream processes and displays the results on the CADstream server or a client personal computer.
Available features support:
- . Visualization (standard image viewing tools, MIPs, and reformats)
- Analysis (registration, subtractions, coil inhomogeneity correction, kinetic curves, parametric image maps, apparent diffusion coefficient maps, automatic and manual segmentation and 3D volume rendering)
- Reporting of user-selected findings and assessment
- Interventional planning
- Workflow efficiency ■
- 예 Communication and storage (DICOM import/export, query/retrieve, and study storage)
The CADstream system consists of proprietary software developed by Merge Healthcare installed on an off-the-shelf computer.
The provided 510(k) summary for CADstream Version 5 (K092954) states that the device modification primarily involves adding capabilities for calculating and presenting apparent diffusion coefficient (ADC) maps and values. It emphasizes that this change is consistent with previously cleared indications for use and does not alter the fundamental scientific technology.
Therefore, the performance testing described focuses on demonstrating that the new ADC functionality meets acceptance criteria related to its implementation and the existing functionalities.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New ADC functionality: |
- Correct calculation and presentation of ADC maps and values.
- Integration into existing CADstream workflow.
- No adverse impact on previously cleared functionalities. | The submission states: "The potential hazards of adding the ADC map functionality have been studied and controlled as part of the product development process, including risk analysis and design considerations." and "The successful completion of verification testing has demonstrated conformance to design controls, user needs, and intended use, and that the device is safe and effective." |
| Overall Device Safety and Effectiveness (for the modified device): - Continues to meet intended use as an image processing system for visualization, analysis, and reporting of MRI studies.
- Maintains safety and effectiveness as demonstrated by the predicate devices. | The submission concludes: "Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
The document states "verification testing was completed" but does not provide details regarding the sample size of the test set, or the specific provenance (country of origin, retrospective/prospective nature) of the data used for this testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The 510(k) summary does not specify the number of experts or their qualifications used to establish ground truth for the verification testing. Given that the modification is primarily software-based for a calculation and presentation feature (ADC maps), the "ground truth" for this specific modification would likely relate to the accuracy of the algorithm's output compared to expected mathematical results or established reference methods, rather than expert interpretation of a diagnostic outcome. The general indications for use, however, mention interpretation by a "skilled physician."
4. Adjudication method for the test set
The document does not specify any adjudication method used for the test set.
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 was done or reported in this 510(k) summary. The modification described is focused on the technical implementation of ADC calculation and presentation, not on evaluating human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The provided information indicates that "verification testing was completed," but does not explicitly detail whether standalone algorithm-only performance testing was conducted for the ADC functionality. Given the nature of ADC calculation, it is highly probable that the verification testing involved evaluating the algorithm's output accuracy against known inputs or established methods, which can be considered a form of standalone performance evaluation for that specific feature. However, the document does not break down the testing in this way.
7. The type of ground truth used
For the specific modification (ADC map functionality), the ground truth would likely be mathematical accuracy and fidelity to established methods for calculating ADC values. This would involve comparing the device's calculated ADC maps and values against highly accurate reference calculations or values derived from well-defined input MRI sequences. The document does not explicitly state the type of ground truth beyond "conformance to design controls, user needs, and intended use."
8. The sample size for the training set
The 510(k) summary does not mention a training set sample size or details about any machine learning training for this specific modification. The change described (ADC map calculations) suggests a deterministic algorithmic implementation rather than a machine learning model that would require a distinct training set.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not applicable and not provided in the document.
§ 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).