(56 days)
ResolutionMD™ 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.
ResolutionMD™ 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.
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.
ResolutionMD™ 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.
ResolutionMDTM is available in a Microsoft Windows version and in a Macintosh OS version. Both 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) images, and 2D and 3D image measurements. The user controls these functions with a system of interactive menus and tools.
The provided text describes a 510(k) summary for the ResolutionMD™ software, a Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria for a study proving device performance, nor details of such a study.
The text focuses on the device description, its intended use, a comparison to predicate devices, and the FDA's clearance letter acknowledging its substantial equivalence.
Therefore, for aspects related to acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, and comparative effectiveness studies, the provided document does not contain the requested information.
Here's what can be extracted and what is explicitly not available from the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
- The document states: "The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria."
- No specific acceptance criteria (e.g., quantifiable metrics like sensitivity, specificity, or error rates) or reported device performance data are provided. The comparison table lists features and functionality against predicate devices, not performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Not available. The document states "ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers." This describes testing activities but does not provide details about a formal test set, its sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not available. There is no mention of ground truth establishment methodology or the use of experts for this purpose in the context of performance evaluation.
4. Adjudication Method for the Test Set
- Not available.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not available. No mention of an MRMC study or an effect size for human readers with and without AI assistance is present. As this is a PACS viewing and processing software, not an AI diagnostic tool, such a study would generally not be expected.
6. Standalone (Algorithm Only) Performance Study
- Not available. The document describes a software PACS for display and visualization, which inherently involves human interaction, so a "standalone" algorithm-only performance might not be directly applicable in the same way it would for an AI-driven diagnostic algorithm. The testing described is focused on the software's functionality and safety.
7. Type of Ground Truth Used
- Not available.
8. Sample Size for the Training Set
- Not available. This device is a PACS viewing software, not an AI model that typically requires a 'training set' in the machine learning sense. The software's development likely involved standard software engineering and quality assurance practices, rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not available. (See point 8)
Summary of available information related to validation:
- Testing Philosophy: The software underwent testing by development, quality control teams, and beta testers. A hazard analysis was conducted, classifying the level of concern as "minor."
- Outcome of Testing: The release version "passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria."
- Substantial Equivalence: The ultimate proof of the device's acceptability for market clearance is its "substantial equivalence" to legally marketed predicate devices (Lucion™, Plug 'n View 3D™, Vitrea 2™), based on intended use and technological characteristics. The provided table highlights functional similarities (e.g., DICOM compliance, 2D/3D imaging, measurement tools, MIP).
In conclusion, while the document confirms the device passed internal tests and was deemed substantially equivalent, it lacks the detailed quantitative performance data and study methodologies typically found in submissions for AI-powered diagnostic devices or those requiring specific performance metrics against a clinical ground truth. This is consistent with a PACS software device submission from 2006, where the focus would be more on functionality, safety, and equivalence to existing cleared devices rather than a detailed clinical performance study comparing against ground truth in a large cohort.
§ 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).