(143 days)
iSchemaView's RAPID 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 images. Data and images are acquired through DICOM compliant imaging devices.
The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
RAPID CT-Perfusion and RAPID MR-Perfusion can be used by physicians to aid in the selection of acute stroke patients. (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery) for endovascular thrombectomy.
Instructions for use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in product-specific iodinated CT and gadolinium-based MR contrast drug labeling.
In addition to the RAPID imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions.
Contraindications/Exclusions:
- · Bolus Quality: absent or inadequate bolus.
- · Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
- Presence of Hemorrhage
RAPID 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) 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.
RAPID works with the following types of (DICOM compliant) medical image data:
- CT (Computed Tomography)
- MRI (Magnetic Image Resonance) ●
RAPID acquires (DICOM compliant) medical image data from the following sources:
- DICOM file
- DICOM CD-R ●
- Network using DICOM protocol .
RAPID provides tools for performing the following types of analysis:
- . selection of acute stroke patients for endovascular thrombectomy
- volumetry of thresholded maps
- . time intensity plots for dynamic time courses
- measurement of mismatch between labeled volumes on co-registered image ● volumes
- . large vessel density
RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server). The RAPID Server is an image processing engine that connects to a hospital LAN, inside the Hospital Firewall. It can be a dedicated RAPID Server or a VM RAPID appliance, which is a virtualized RAPID Server that runs on a dedicated hospital server. Where available, the RAPID Server is placed logically in the demilitarized zone (DMZ) of the hospital's network to facilitate bidirectional secure connection between the (local) RAPID Server and the centralized iSchemaView Server.
RAPID is a software-only device designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. RAPID is typically installed on a server running within a hospital's network and operates with minimal user interaction. Once the CT or MR data are acquired, the CT or MRI console operator selects RAPID as the target for the DICOM images, and then the operator selects which study/series data to be sent to RAPID. Based on the type of incoming DICOM data, RAPID will identify the data set as CT or MRI data, and determine the suitable processing module. RAPID is a toolbox of modules which support various analysis methods used in clinical practice today:
- . RAPID CTA: used to visualize large cerebral vessels and analyze hemispheric difference via contralateral comparison.
- RAPID MR DWI Module: used to visualize local water diffusion properties of tissue . from the analysis of diffusion-weighted MRI data.
- RAPID Dynamic Analysis Module: used for visualization and analysis of dynamic . imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
The iSchemaView Server is a dedicated server that provides a central repository for RAPID data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing RAPID data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more RAPID Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).
I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets them in the requested format.
The document is an FDA 510(k) summary for the iSchemaView RAPID device. It focuses on demonstrating substantial equivalence to a predicate device (K172477) rather than detailing a specific clinical performance study with acceptance criteria and results.
While it mentions performance validation testing, software verification and validation, and conformance to standards, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm study.
- The type of ground truth used in detail for a performance study.
- Training set sample size or how its ground truth was established.
The document highlights the intended use changes and technological characteristics to demonstrate equivalence, but not the specific performance metrics and studies that would prove it meets acceptance criteria for the expanded indication.
§ 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).