(161 days)
The ResolutionMD™ 2.1 is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionMD™ 2.1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on noncontrast enhanced cardiac CT data sets. It also includes the Coronary Artery Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.
The ResolutionMD™ 2.1 software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD™ 2.1 software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
The ResolutionMD™ 2.1 is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.
The ResolutionMD™ 2.1 is available in a Microsoft Windows version, a Microsoft .NET software development kit version (SDK), a Linux Web server version and in a Macintosh OS version. All versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) and multiplanar reconstruction images (MIP/MPR), 2D and 3D image measurements, calcium scoring, and coronary artery analysis. The user controls these functions with a system of interactive menus and tools.
The provided text describes the ResolutionMD™ 2.1, a software-based Picture Archiving and Communication System (PACS) for displaying and visualizing medical image data. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics.
The document is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.
Here's a breakdown of what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy, precision, processing speed) or a study reporting such performance against those criteria. It focuses on functional equivalence to predicate devices.
2. Sample Size for the Test Set and Data Provenance
Not available. The document does not describe a test set, its sample size, or its data provenance. It mentions "extensive testing on supported platforms by members of the development and quality control team" and "Beta testing by trained cardiology professionals and potential customers" but provides no details on these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available. Since no specific test set or performance evaluation study is described, there is no information on ground truth establishment or expert involvement for such a study. The document mentions "trained professionals such as physicians, technologists, and nurses" as intended users, and "trained cardiology professionals" for beta testing, but not for ground truth establishment.
4. Adjudication Method for the Test Set
Not available. No test set or corresponding adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available. The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is a PACS system with visualization and analysis tools, not an "AI" in the sense of an automated diagnostic algorithm that would typically be evaluated in an MRMC study for improved reader performance.
6. Standalone (Algorithm Only) Performance Study
Not available. The document describes a PACS system with various imaging and analysis functionalities (2D/3D imaging, measurements, calcium scoring, artery analysis). It doesn't detail a standalone performance study of any specific algorithm within the system. The focus is on the integrated system's functionality being substantially equivalent to predicate devices.
7. Type of Ground Truth Used
Not available. No specific performance study is detailed, therefore no ground truth type (e.g., expert consensus, pathology, outcome data) is specified.
8. Sample Size for the Training Set
Not available. The document does not mention any "training set" as it describes a software product, not a machine learning model that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
Not available. As there is no mention of a training set, there is no information on how its ground truth might have been established.
Summary of what is present:
The document primarily serves as a 510(k) application, focusing on:
- Device Description: ResolutionMD™ 2.1 is a software-based PACS for display and 3D visualization of medical image data (CT, MRI), with features like 2D/3D imaging, measurements, MIP/MPR, segmentation, calcium scoring, and coronary artery analysis.
- Intended Use: Diagnostic, review, and analysis tool for trained professionals. Images reviewed by a trained physician may be used as an element for diagnosis.
- Substantial Equivalence: Demonstrated against Vital Vitrea2™ and Vital Connect 4.1 in terms of platform, DICOM compliance, access, imaging features, measurement tools, and intended users.
- Hazard Analysis: Conducted and classified as minor.
- Testing: "Extensively tested on supported platforms" by development and QC teams, followed by "Beta testing by trained cardiology professionals and potential customers." However, no details on the scope, methodology, or results of this testing are provided beyond general statements about passing critical safety tests and demonstrating acceptable performance.
In conclusion, this document explicitly states that "The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria." However, it does not provide the specific "predefined release criteria" or the results of the study that proves the device meets them.
§ 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).