(208 days)
nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast over time. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be used to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
The nordicTumorEx Software is a post-processing application for dynamic MRI data developed with a view to ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The software encompass well-established analysis methods and dedicated visualization tools for dynamic contrast enhanced imaging data from MRI where a bolus injection of a contrast agent material results in a temporal change in the signal intensity. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow (perfusion) and tissue blood volume as well as leakage (due to capillary permeability) of the injected contrast material from the intracellular space. These parameters and their derived properties together with anatomical/structural MR images are presented to support the diagnostic process.
The application workflow has been optimized to ensure efficiency and high throughput in a clinical environment.
The provided text is a 510(k) summary for the nordicTumorEx Software. It describes the device, its intended use, and states that performance testing was conducted. However, it does not present specific acceptance criteria or details of a study with reported performance metrics that directly demonstrate the device meets those criteria.
The document states: "Prospectively defined verification and validation activities for the nordicTumorEx Software assure that the nordicTumorEx Software meets design and performance specifications as well as user needs when operated according to the operating instructions." This is a general statement about the testing performed, but it lacks the quantitative results needed to populate the requested table or answer most of the questions about a specific performance study.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or reported device performance metrics are provided in the document. The document states that "verification and validation activities... assure that the nordicTumorEx Software meets design and performance specifications," but what those specifications are and what the quantitative results were are not detailed.
Study Details (Based on available information)
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 specified. The device is described as a post-processing application for image analysis and visualization, not explicitly an AI-assisted diagnostic tool in the sense of comparative effectiveness with human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a standalone performance study. The description suggests it's a tool for "trained professionals," implying human interaction.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified.
- The sample size for the training set: Not specified.
- How the ground truth for the training set was established: Not specified.
Conclusion:
The provided 510(k) summary (K123306) describes the nordicTumorEx Software and its intended use, and states that performance testing was conducted. However, it does not include the detailed, quantitative results or acceptance criteria of those performance tests. A typical 510(k) summary would often refer to an internal report (e.g., a Verification and Validation Report) from which these details could be drawn, but the summary itself generally does not contain them in this depth. Therefore, the majority of the requested information cannot be provided from this 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).