(56 days)
JLK-PWI 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 computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of Diffusion-weighted imaging (DWI) and Perfusion-weighted imaging (PWI) images for the brain from Magnetic Resonance Imaging (MRI) systems. Data and images are acquired through DICOM-compliant imaging devices. JLK-PWI provides both viewing and analysis capabilities for dynamic imaging datasets obtained through MRI protocols.
The DWI analysis capabilities are used to analyze local water diffusion properties from diffusion-weighted MRI data.
The PWI analysis capabilities are for analyzing dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculating parameters related to tissue flow (perfusion) and tissue blood volume.
JLK-PWI is image processing software designed to analyze Diffusion-weighted imaging (DWI) and Perfusionweighted imaging (PWI) images from Magnetic Resonance Imaging (MRI) scanners. The software calculates local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images.
JLK-PWI can be used to communicate with a DICOM-compliant device or a PACS server to receive DWI and PWI images. The software is designed to automatically receive and analyze DWI and PWI images with DICOM image data. The analyzed diffusion and perfusion parameters, which are related to the tissue blood flow and volume, are written to the source DICOM and stored in the data storage. Medical professionals can review the analysis results through the implemented user interface (UI) or a connected PACS server.
The FDA 510(k) summary for JLK-PWI presents the following information regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. | "JLK-PWI demonstrated reliable and accurate performance in calculating local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images." |
| "The software's results were substantially equivalent to those obtained using RAPID." | |
| "These results indicate that JLK-PWI meets the predetermined performance criteria, validating its reliability and accuracy in analyzing DWI and PWI images." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set.
The data provenance is not explicitly stated in terms of country of origin or explicit retrospective/prospective study design for the performance validation. However, the context implies the data would be real-world medical image data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications.
4. Adjudication Method for the Test Set
The document does not explicitly describe the adjudication method used for the test set. It mentions comparison to "results obtained using RAPID," suggesting the predicate device's output may have served as a reference in some capacity, but no expert adjudication method is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not discussed in the provided summary as a method for evaluating the device's performance. The study focused on the standalone performance of JLK-PWI and its equivalence to the predicate.
6. Standalone Performance Study
Yes, a standalone performance study was done. The summary states, "JLK-PWI demonstrated reliable and accurate performance in calculating local water diffusion properties from DWI images and the perfusion area, which is a delayed perfusion area, using the analyzed perfusion map from PWI images." This indicates that the algorithm's performance was evaluated independently.
7. Type of Ground Truth Used
The primary "ground truth" or reference standard used for evaluating JLK-PWI's performance appears to be the results generated by the legally marketed predicate device, iSchemaView RAPID (K121447). The summary states, "The software's results were substantially equivalent to those obtained using RAPID." This suggests a comparative approach where RAPID's output served as the benchmark.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for the training set.
9. How Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established.
Summary of Study Information Provided:
The provided 510(k) summary focuses primarily on asserting that JLK-PWI's performance, particularly in calculating DWI and PWI parameters, is reliable, accurate, and "substantially equivalent" to that of the predicate device, iSchemaView RAPID. While it indicates that "extensive performance validation testing and software verification" were conducted, many specific details about the study design, such as sample sizes for test and training sets, data provenance, expert involvement for ground truth, and adjudication methods, are not explicitly provided in this summary. The primary claim of meeting acceptance criteria is through demonstrating "substantial equivalence" to the predicate device's results.
§ 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).