(98 days)
nordiclCE 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.
nordic!CE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRJ, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
nordiclCE – Nordic Image Control and Evaluation software – is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.
The provided 510(k) summary (K090546) for the nordicICE Software does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
This document is a 510(k) premarket notification for a modification to an existing device (nordicICE). The modification involves adding new software modules for dynamic contrast-enhanced imaging data analysis (Perfusion and DCE Modules).
Here's what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Missing. The document states, "The nordicICE software has been tested for function and safety and fulfills all requirement specifications." However, it does not provide any specific acceptance criteria (e.g., performance metrics, thresholds) or report any quantitative device performance data from a validation study.
2. Sample Size Used for the Test Set and Data Provenance
- Missing. The document does not mention any test set, sample size, or the provenance (country of origin, retrospective/prospective) of any data used for testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Missing. There is no mention of experts, ground truth establishment, or their qualifications.
4. Adjudication Method
- Missing. No information on adjudication methods is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Missing. There is no indication that an MRMC study was performed, nor any data on human reader improvement with or without AI assistance. The device is primarily a viewing, processing, and analysis tool, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.
6. Standalone (Algorithm Only) Performance Study
- Missing. While the device offers analysis capabilities, the document does not describe a standalone performance study where the algorithm's output is compared against a ground truth without human intervention. The nature of the device as a "viewing, analysis, and processing package" suggests it's primarily a tool for professionals, rather than a fully autonomous diagnostic algorithm.
7. Type of Ground Truth Used
- Missing. The document does not describe any specific ground truth used for testing or validation of the expanded functionality.
8. Sample Size for the Training Set
- Missing. There is no mention of a training set, as the document focuses on modifications to an existing software package and its functional testing rather than a new machine learning algorithm that requires extensive training data.
9. How the Ground Truth for the Training Set Was Established
- Missing. As no training set is mentioned, information on how its ground truth was established is also absent.
Summary of available information related to testing:
The document states:
"The nordicICE software has been tested for function and safety and fulfills all requirement specifications."
This statement confirms that testing was conducted to ensure the device met its functional and safety requirements, but it does not provide any details about the methodologies, data, or results of these tests, especially concerning clinical performance or diagnostic accuracy. The 510(k) process for this type of modification often relies on functional verification and validation that the new modules perform as intended and do not introduce new safety concerns, rather than extensive clinical comparative studies, particularly when the device is an image processing tool rather than a diagnostic algorithm.
§ 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).