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Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive ICA or MCA-M1 Large Vessel Occlusion (LVO) findings in head CTA images.

Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO findings. Notifications include compressed preview images. These are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Rapid LVO are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Rapid LVO is a radiological computer-assisted triage and notification software device. The Rapid LVO module is a contrast enhanced CTA module which operates within the integrated Rapid Platform to provide triage and notification of suspected ICA and MCA-M1 Large Vessel Occlusion (LVO) based on the following definitions:

ICA Occlusion: A high-grade stenosis or occlusion of the intracranial portion of the ICA.

MCA-M1 Occlusion: A high-grade stenosis or occlusion of the horizontal segment of the MCA-M1, defined as the segment which extends from the ICA terminus until the vessel has turned upward into the Sylvian fissure. This includes post-bifurcation M1 segments in some patients.

The LVO module uses traditional programming algorithms. The output of the module is a priority notification to clinicians indicating the suspicion of LVO based on positive findings. The Rapid LVO module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

The Rapid LVO device, a radiological computer-aided triage and notification software for detecting Large Vessel Occlusions (LVO) in CTA head images, was evaluated against specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Additionally, the following performance metrics were reported:

• Positive Predictive Value (PPV): 0.98
• Negative Predictive Value (NPV): 0.96
• Receiver Operating Characteristic (ROC) AUC: 0.99

2. Sample Size and Data Provenance for the Test Set

   • Sample Size: 217 scans (135 positive LVO cases, 82 negative LVO cases).
   • Data Provenance: The data was collected from 8 sites/studies, with locations in both the US and OUS (Outside the US). The document does not explicitly state if the data was retrospective or prospective, but clinical validation testing typically uses retrospective data for ground truth establishment.

3. Number of Experts and Qualifications for Ground Truth

   • Number of Experts: Three expert neuroradiologists.
   • Qualifications: They are described as "expert neuroradiologists." Specific years of experience are not provided.

4. Adjudication Method for the Test Set

   • The ground truth was established using a "2:3 concurrence" method. This implies that at least two out of the three expert neuroradiologists had to agree on the presence or absence of an LVO for a case to be assigned its ground truth label.

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

   • No MRMC comparative effectiveness study was mentioned. The study focused on the standalone performance of the algorithm.

6. Standalone Performance Study

   • Yes, a standalone performance study was conducted. The reported sensitivity, specificity, PPV, NPV, and ROC AUC are all measures of the algorithm's performance without human-in-the-loop assistance.

7. Type of Ground Truth Used

   • The ground truth was established by "expert neuroradiologists" using a "2:3 concurrence" method. This indicates expert consensus was the basis for the ground truth.

8. Sample Size for the Training Set

   • The document does not explicitly state the sample size used for the training set. It only details the validation set used for performance testing.

9. How Ground Truth for the Training Set Was Established

   • The document does not provide details on how the ground truth for the training set was established. It only describes the ground truth establishment for the validation/test set.

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Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images.

Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Rapid LVO are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Rapid LVO 1.0 is a clinical module which operates within the integrated Rapid Platform to provide triage and notification of suspected Large Vessel Occlusion (LVO). The Rapid LVO module consists of the core Rapid Platform software which provides the administration and services for the Rapid image processing modules; and the Rapid LVO module which functions as one of many image processing modules hosted by the platform.

Rapid LVO acquires (DICOM compliant) medical image data from CTA scanners through the Rapid Platform interface.

The Rapid platform is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography), CTA, XA and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities. The Rapid platform has multiple modules a clinician may elect to run and provide analysis for decision making. The basic architecture supports the general functionality to support the Rapid LVO imaging module such as DICOM interfaces, job management, data base functions and communications. The Rapid Platform and base functions are not under review for this submission.

The provided document (K200941) describes the 510(k) premarket notification for the iSchemaView Rapid LVO 1.0 device. Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for standalone performance were specified as exceeding an 80% goal for both Sensitivity (Se) and Specificity (Sp) using the lower bound of the 95% Confidence Interval. Additionally, a time-to-notification goal of less than 3.5 minutes was established based on the predicate device.

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