Search Results

JLK-CTP 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 CT perfusion images for the brain.

Data and images are acquired through DICOM compliant imaging devices.

JLK-CTP provides both viewing and analysis capabilities for dynamic imaging datasets obtained through CT Perfusion protocols.

The analysis is for visualization and examination of imaging data, revealing characteristics of contrast changes over time. This functionality includes the calculation of CT perfusion parameters associated with tissue flow (perfusion) and tissue blood volume.

JLK-CTP is image processing software designed to analyze CT perfusion (CTP) images. Using the analyzed perfusion map, the software calculates the volume of the reduced cerebral blood flow (CBF) area and the volume of the delayed Tmax area in the CTP images.

JLK-CTP can be used to communicate with a DICOM-compliant device or a PACS server to receive CTP images. The software is designed to automatically receive and analyze a head CTP image with DICOM image data. The analyzed perfusion parametric maps, which are related to the tissue blood flow and volume, are written to the source DICOM and stored in the data storage. Users can review the analysis results through the implemented user interface (UI) or a connected PACS server.

JLK-CTP Device Acceptance Criteria and Study Details

The provided FDA 510(k) summary for the JLK-CTP device describes its intended use as an image processing software for analyzing CT perfusion (CTP) images of the brain. The primary goal of the regulatory submission is to demonstrate substantial equivalence to the predicate device, iSchemaView RAPID (K121447).

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that JLK-CTP "demonstrated reliable and accurate performance in calculating the reduced blood flow and delayed Tmax tissue volumes. The software's results were substantially equivalent to those obtained using RAPID." While explicit quantitative acceptance criteria are not detailed in this summary, the implicit acceptance criterion is demonstrated substantial equivalence to the predicate device, RAPID, in terms of its ability to calculate these perfusion parameters.

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 or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "extensive performance validation testing," but no specific numbers are provided in this summary.

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 or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison is made to "results obtained using RAPID," suggesting a comparative analysis to the predicate's output rather than an independent expert adjudication of each case.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The focus of this submission appears to be on the standalone performance of the algorithm in comparison to the predicate device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The summary explicitly states: "JLK-CTP demonstrated reliable and accurate performance in calculating the reduced blood flow and delayed Tmax tissue volumes. The software's results were substantially equivalent to those obtained using RAPID." This indicates that the performance of the JLK-CTP algorithm itself was evaluated and compared to the output of the predicate device.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be the results of the predicate device, iSchemaView RAPID. The summary repeatedly emphasizes that JLK-CTP's results were "substantially equivalent to those obtained using RAPID." This implies that RAPID's output was used as the reference standard for comparison.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. Given the comparison to the predicate device for evaluation, it is plausible that data processed by the predicate, or data with established clinical interpretation, would have been used for training, but this is not confirmed in the provided text.

Ask a specific question about this device