(246 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 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:
- volumetry of threshold 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).
Here's an analysis of the acceptance criteria and supporting study for the iSchemaView RAPID device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
The provided document describes the iSchemaView RAPID device (K172477) as substantially equivalent to its predicate device (K121447). The acceptance criteria, while not explicitly listed in a detailed quantitative manner, can be inferred from the "Substantial Equivalence Discussion" table and the claims made regarding the device's performance. The primary acceptance criterion is that the new device (K172477) performs at least as well as, and ideally expands upon, the capabilities of the predicate device (K121447) without introducing new safety or effectiveness concerns.
The core performance claims verified through testing are:
- Accurate representation of key processing parameters under clinically relevant conditions.
- Meeting all design requirements and specifications.
- Reliable processing and analysis of CT and MRI medical images for tissue evaluation.
- Successful integration of the CTA modality.
Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary for substantial equivalence, the "acceptance criteria" are framed around matching or improving upon the predicate device's capabilities and regulatory compliance.
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (K172477) |
|---|---|
| Intended Use/Indications for Use: Same as K121447, plus inclusion of CTA modality. | Meets/Exceeds: "iSchemaView's RAPID is an image processing software package to be used by trained professionals... The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion, CT Angiography, and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module..." The indications are identical to the predicate except for the explicit inclusion of CT Angiography. This is an expansion of functionality. |
| PACS Functionality: Same basic PACS functions (view, process, analyze, query, list). | Meets: "Performs standard PACS functions with respect to querying and listing." "View, process and analyze medical images." (Same as predicate). |
| Computer Platform: Standard off-the-shelf PC/server or virtual platform. | Meets: "Standard off-the-shelf PC workstation/server; Virtual platform such as VMware" (Same as predicate). |
| DICOM Compliance: Yes. | Meets: "Yes" (Same as predicate). |
| Functional Overview: Software for visualization and study of tissue changes in CT/MRI, providing viewing and quantification. | Meets: "RAPID is a software package that provides for the visualization and study of changes of tissue in digital images captured by CT and MRI. RAPID provides viewing and quantification." (Same as predicate). |
| Data Acquisition: Acquires medical images from DICOM compliant devices/modalities. | Meets: "Acquires medical image data from DICOM compliant imaging devices and modalities" (Same as predicate). |
| Data/Image Types: CT and MRI via DICOM. | Meets: "Computed Tomography (CT) via DICOM Format; Magnetic Image Resonance (MRI) via DICOM Format" (Same as predicate). |
| Acquisition & Modalities Features (MRI): DWI and Dynamic Analysis (perfusion & blood volume). | Meets: "Diffusion Weighted Image (DWI); Dynamic Analysis tissue flow (perfusion) and tissue blood volume" (Same as predicate). |
| Acquisition & Modalities Features (CT): CT Perfusion (CTP). | Meets/Exceeds: "CT Perfusion (CTP); CTA-large vessel density analysis" (The CTA analysis is new for K172477, whereas K121447 only had CT-P Analysis). This is a key enhancement. |
| Computed Parameter Maps (Diffusion MRI): isoDWI, ADC, Trace, FA, color FA. | Meets: "Isotropic DWI (isoDWI); ADC; Trace of diffusion tensor (Trace); Fractional Anisotropy (FA) and color FA" (Same as predicate). |
| Computed Parameter Maps (Perfusion MRI & CT): CBF, CBV, MTT, Tmax. | Meets: "Cerebral blood flow (CBF); Cerebral blood volume (CBV); Mean transit time (MTT); Tissue residue function time to peak (Tmax)" (Same as predicate). |
| Measurement Tools (MRI and CT): AIF, VOF, Time-course, Mask, ROI, Volumetry, volumetric comparison, motion correction, export files, acquire/transmit/process/store images. | Meets: "Arterial input function (AIF)Venous output function (VOF); Time-course; Mask; Region of interest (ROI) and Volumetry; Volumetric comparison between 2 ROIs; Motion correction; Export perfusion and diffusion files to PACS and DICOM file systems; Acquire, transmit, process, and store medical images" (All listed as similar or identical to predicate). |
| Reliability and Accuracy: Processes and analyzes images reliably to provide accurate representation of parameters and meet design requirements. | Meets: "...confirms the software reliably processes and supports analysis of CT and MRI medical images for tissue evaluation." "This performance validation testing demonstrated that the RAPID system provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the RAPID system met all design requirements and specifications." |
| Safety and Effectiveness: Compliant with 21 CFR, Part 820.30 and EN ISO 14971:2012. | Meets: "RAPID has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2012 (risk management)." |
| No New Safety/Effectiveness Issues: Introduction of new features (e.g., CTA) does not create new safety or effectiveness concerns. | Meets: "The minor differences between the RAPID (K172477) and its predicate (K121447) raise no new issues of safety or effectiveness as demonstrated by the testing conducted with RAPID (K172477) that confirms the software reliably processes and supports analysis of CT and MRI medical images for tissue evaluation." |
The study that proves the device meets the acceptance criteria is referred to as "extensive performance validation testing and software verification and validation testing of the RAPID system."
Detailed Information on the Study:
-
Sample Size used for the test set and the data provenance:
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only broadly states "extensive performance validation testing." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications used to establish ground truth for testing. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for establishing ground truth or evaluating the test set. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human improvement with AI assistance. The focus is on the software's standalone performance and its comparison to its own predicate device. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone performance evaluation was conducted. The document states:- "This performance validation testing demonstrated that the RAPID system provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software."
- "Performance, validation and verification testing demonstrated that the RAPID system met all design requirements and specifications."
- "The RAPID System performance has been validated through the use of phantoms."
These statements indicate testing of the algorithm itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "performance validation testing," the document explicitly mentions that "The RAPID System performance has been validated through the use of phantoms." This indicates that, at least in part, the ground truth was established through known physical or digital models with predefined characteristics. It's also implied that the system's output was compared against "key processing parameters" which likely have established normal or pathological ranges, potentially derived from expert knowledge or clinical standards, though this is not explicitly detailed. -
The sample size for the training set:
The document does not specify the sample size for the training set. This information is typically not included in a 510(k) summary focused on substantial equivalence. -
How the ground truth for the training set was established:
The document does not specify how the ground truth for the training set (if any distinct training set was used separate from the predicate's development) was established. Given the context of a 510(k) for an updated version of an already cleared device, much of the development would likely build upon the established datasets and methodologies from the predicate.
§ 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).