(131 days)
The Rology Teleradiology Platform is a Web-based software system used to receive, view and manipulate DICOM images, schedule, provide textual reports, organize, store, and make such information available.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the qualified clinician to determine if the image quality is suitable for their clinical application.
The Rology Teleradiology Platform is intended to be used by clinicians qualified in the use of radiological images for interpretation/diagnosis.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
Rology Teleradiology Platform developed by Rology Inc. is a Software as a Medical Device (SaMD) system used to receive DICOM images, schedule information, and textual reports, organize and store them in an internal format, and make that information available across a network via web and customized user interfaces.
The Rology Teleradiology Platform is intended to be used by trained and qualified healthcare professionals, including radiologists, technologists, and medical professionals, in hospitals, clinics, and medical imaging centers, to aid the radiologists in reading, interpreting, and reporting. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained radiologist to determine if the image quality is suitable for their clinical application, so the radiologist retains the ultimate responsibility for making the final diagnosis decision.
Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.
Rology Teleradiology Platform is designed to integrate with current medical systems through standard medical protocols:
- . DICOM: for exchanging medical imaging.
- HL7/FHIR: for exchanging electronic health records .
The Rology Teleradiology Platform is to be used to view DICOM-compliant studies, which are stored in the cloud using to AWS's S3 service and is intended for professional use only as a viewing tool for medical image studies. The Rology Teleradiology Platform is comprised of the following modules/functions:
- Acquiring studies by the Rology Connect module which allows for the automatic . acquisition of images from DICOM-compliant devices. It receives, anonymizes, compresses, and uploads the studies to the platform using AWS's S3 service. A third-party DICOM device sends the images to the Rology DICOM node, which will extract DICOM data and upload the images to cloud servers.
- Scheduling and organizing studies after being uploaded by the Workflow Manager. .
- View DICOM-compliant studies using the DICOM Viewer software which will fetch . images and data from backend servers, to allow users to view those images on their personal computers, to diagnose, manipulate, and interpret the studies.
- Report textual/transmission to the healthcare facility using the Reporting Tool which is part of the DICOM Viewer, to Incorporate non-image data, such as scanned documents, using consumer industry standard formats like PDF (Portable Document Format). The report will be sent securely to the healthcare facility for review/acceptance.
The features and functions of Rology DICOM Viewer module, which includes Viewer technology and features include:
General Functions:
- . Receive DICOM images from the acquisition device
- . Textual reports, and transmit the reports securely to the hospital
- Store images in a secure cloud environment .
Basic Imaging functions:
- Grayscale Image Rendering ●
- Localizer Lines ●
- Localizer Point .
- Distance Markers ●
- Study Data Overlays ●
- Stack Navigation Tool ●
- Window/Level Tool
- Zoom Tool ●
- . Panning Tool
- Clockwise/Counterclockwise Rotation .
- Color Inversion ●
- Area Measurement Annotation ●
- Angle Measurement Annotation ●
- . Added keyboard shortcuts for some tools
- Orientation Markers
Advanced imaging functions
- Multi-Planar Reconstruction (MPR) •
- . Maximum Intensity Projection (MIP)
The Rology DICOM Viewer module is the only 'module' of the system that is believed to meet the definition of being a regulated medical device. The other modules of the Rology Teleradiology Platform are included to provide a complete understanding of the software system and its interactions with the intended user(s).
Here's a breakdown of the acceptance criteria and study information for the Rology Teleradiology Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets. Instead, the document describes the testing as "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" The reported performance is a simple "Pass" for each test.
| Performance Test | Reported Device Performance |
|---|---|
| User Interface/Input | Pass |
| Drag and Drop Import | Pass |
| Image Storage | Pass |
| Textual Reports | Pass |
| Database software | Pass |
| Grayscale Image Rendering | Pass |
| RGB Image Rendering | Pass |
| Distance Markers | Pass |
| Study Data Overlays | Pass |
| Stack Navigation Tool | Pass |
| Window Level | Pass |
| Zoom in on the Image | Pass |
| Panning | Pass |
| Invert image | Pass |
| Text Annotation | Pass |
| MIP/MPR Reconstruction | Pass |
| Area Measurement Annotation | Pass |
| Angle Measurement Annotation | Pass |
| User Interface text styles, colors, fonts, and icons. | Pass |
| WebGL Rendering Optimizations | Pass |
| Support for high-resolution Retina displays | Pass |
| Keyboard shortcuts | Pass |
| Localizer Lines | Pass |
| Localizer Point | Pass |
| Color Inversion | Pass |
| Orientation Markers | Pass |
| Clockwise/Counterclockwise Rotation | Pass |
| Search | Pass |
| Cobb Angle Measurement Annotation | Pass |
| Thumbnail viewing | Pass |
| Automatic Upload | Pass |
| Worklist | Pass |
| Download Report | Pass |
| Recheck | Pass |
| Pick up studies | Pass |
| Side-by-side Comparison | Pass |
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 of the data, retrospective or prospective). It simply mentions that "The performance testing (design verification and design validation) verified that the design requirements were successfully met."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was conducted or reported for the Rology Teleradiology Platform in this submission. The device is a teleradiology platform, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted. The Rology Teleradiology Platform is a software system intended to be used by qualified clinicians for viewing and manipulating images, with the clinician retaining ultimate responsibility for diagnosis.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The performance testing appears to be centered around verifying functional requirements rather than diagnostic accuracy against a clinical ground truth. The statement that "The Intended use and user needs were successfully validated using appropriate validation partners representing the intended users of the Rology Teleradiology Platform" suggests user acceptance testing for functionality.
8. Sample Size for the Training Set
The document does not mention a training set. The Rology Teleradiology Platform is described as a "Software as a Medical Device (SaMD) system used to receive DICOM images, schedule information, and textual reports, organize and store them... and make that information available," which suggests it's primarily an image management and viewing system, not an AI/ML diagnostic algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML algorithm, there is no information about how its ground truth was established.
§ 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).