(507 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 brain images. Data and images are acquired through DICOM compliant imaging devices.
iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion 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 diffusionweighted 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 is a software package that provides for the visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT (Computed Tomography) and MRI (Magnetic Image Resonance). RAPID can be installed on a customer PC 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:
- · volumetry of threshold maps
- · time intensity plots for dynamic time courses
- measurement of mismatch between labeled volumes on co-registered image volumes
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 vmRAPID 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.
The RAPID Server is configured to connect to applicable DICOM devices (PACS, Imaging Modalities, Research Workstations) via the hospital LAN and to receive diffusion and perfusion (DICOM) data directly and automatically from imaging modalities as they become available. It processes acquired data and delivers postprocessed images directly back to imaging modalities, local PACS and/or workstations, again using DICOM communication. It also transmits data to the iSchemaView Server for storage, retrieval and viewing.
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 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).
The provided 510(k) summary for iSchemaView, Inc.'s RAPID does not include specific acceptance criteria or an explicit study proving performance against them. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olea Sphere) through a comparison of technological characteristics and a general statement about performance validation testing.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria. The closest information is a comparison of technological characteristics between RAPID and its predicate device, Olea Sphere, to demonstrate substantial equivalence.
| Parameter | RAPID | Olea Sphere (Predicate Device) |
|---|---|---|
| Primary Claim | Substantial Equivalence to Olea Sphere | N/A (Legally marketed predicate) |
| Product Code | LLZ | LLZ |
| Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 |
| Intended Use/ Indications for use | Image processing software for viewing, processing, and analysis of brain images from CT Perfusion and MRI (DWI and Dynamic Analysis Modules for dynamic contrast-enhanced imaging data). Visualizes local water diffusion properties and calculates parameters related to tissue flow (perfusion) and tissue blood volume. | Image processing software for viewing, processing, and analysis of medical images from MRI or other relevant modalities (DWI/Fiber Tracking Module and Dynamic Analysis Module for dynamic contrast-enhanced imaging data). Visualizes local water diffusion properties (and fiber tracking) and calculates parameters related to tissue flow (perfusion), tissue blood volume, and permeability. |
| PACS Functionality | View, process, and analyze medical images. Performs standard PACS functions with respect to querying and listing. | Same |
| Computer Platform | Standard "off-the-shelf" PC workstation (also virtual platform like VMware) | Same |
| DICOM Compliance | (Not explicitly stated in table, but mentioned in body) | Yes |
| Functional Overview | Visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT and MRI. Provides viewing and quantification. | Same |
| Data Acquisition | Acquires medical image data from DICOM compliant imaging devices and modalities | Same |
| Data/Image Types | Computed Tomography (CT), Magnetic Image Resonance (MRI) | Same |
| Acquisition and Modalities Features | MRI: Diffusion Weighted Image (DWI), Perfusion Weighted Image (PWI). CT: CT Perfusion (CTP). | MRI: Yes. CT: Yes. |
| Computed Parameter Maps (DWI) | Isotropic DWI (isoDWI), Exponential apparent diffusion coefficient (eADC), ADC, Trace of diffusion tensor (Trace), Fractional Anisotropy (FA) and color FA, Eigenvector, Eigenvalue | Yes (for all listed DWI parameters) |
| Computed Parameter Maps (Perfusion) | Cerebral blood flow (CBF), Cerebral blood volume (CBV), Mean transit time (MTT), Tissue residue function time to peak (Tmax) | Yes (for all listed perfusion parameters), plus Permeability Module parameters. |
| Measurements/Tools | Arterial input function (AIF)/Venous output function (VOF), Time-course, Brain mask, Region of interest (ROI) and Volumetry, Volumetric comparison between 2 ROIs, Motion correction, Export perfusion and diffusion files to PACS and DICOM, Acquire, transmit, process, and store medical images | Yes (for all listed tools) |
Performance Statement:
The document states: "iSchemaView conducted extensive performance validation testing and software verification and validation testing of the RAPID system. This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software validation and verification testing demonstrated that the RAPID system met all design requirements and specifications."
This is a general statement about the existence of testing, but it does not detail specific acceptance criteria (e.g., "accuracy must be > 95% for parameter X against ground truth Y") nor does it provide quantitative results.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data used for performance validation.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not mention using experts to establish ground truth for a test set, nor does it specify the number or qualifications of any such experts.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size of how much human readers improve with AI vs. without AI assistance. The focus is on the device's standalone processing capabilities, not its impact on human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the implied performance validation is focused on the standalone algorithm. The statement "This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters" suggests algorithmic accuracy and reliability, rather than human-in-the-loop performance. However, specific details of this standalone performance (e.g., accuracy metrics, specific parameters tested) are not provided in this 510(k) summary.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any validation. It broadly refers to showing "accurate representation of key diffusion and perfusion processing parameters," which implies comparison against some reference standard, but doesn't specify if this was expert consensus, pathology, outcomes data, a phantom, or another method.
8. The Sample Size for the Training Set
The document does not mention any training set or its sample size. This 510(k) summary is for a software package that processes images based on established physiological models for diffusion and perfusion, rather than a machine learning or AI model that typically requires a discrete training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.
In summary: The provided 510(k) summary focuses almost exclusively on demonstrating substantial equivalence to a predicate device by comparing technical specifications and intended use. It describes the device's functionality and its role in processing medical images based on established scientific principles. It states that performance validation testing was conducted and that the system met design requirements, but it does not provide any specific quantitative acceptance criteria, details of the study design (e.g., sample size, data provenance), ground truth methodology, or reader study results. This type of summary for software performing calculations based on known physical models often relies on verification and validation against those models, rather than clinical efficacy studies with ground truth derived from pathology or expert consensus.
§ 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).