(125 days)
Indications for Use Statement for ResolutionMD:
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.
ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations.
ResolutionMD is not to be used for primary mammography diagnoses.
Indications for Use Statement for ResolutionMD with Vessel Analysis module:
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.
ResolutionMD incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD. It is a tool for use by trained healthcare professionals to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum lumen diameters and length measurements.
ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations.
ResolutionMD is not to be used for primary mammography diagnoses.
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.
ResolutionMD incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD. It is a tool for use by trained healthcare professionals to review, edit, analyze and report findings of vascular anatomy.
The provided text is a 510(k) summary for the ResolutionMD software and its Vessel Analysis module. It describes the device, its indications for use, and claims substantial equivalence to previously cleared ResolutionMD devices. However, the document does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.
The available information regarding testing is general:
- Software Verification and Validation Testing: "Verification testing consisting of more 2000 separate tests, each executed multiple times by different testers, was performed for this device. Testing included functional, smoke and regression tests and was also complemented by beta tests performed by Calgary Scientific's distribution partners. The vast majority of tests passed our testing criteria. Any defects found or reported were either fixed or logged in the Unresolved Anomalies report included with this submission and annotated as to any impact on safety or effectiveness including applicable workarounds. Validation testing based on typical clinical workflows was performed by trained radiology personnel. Validation includes usability assessment and consistency across all client platforms."
This general description of verification and validation testing, while stating that a "vast majority of tests passed our testing criteria," does not provide a table of acceptance criteria, reported device performance metrics against those criteria, or the details of a study as requested in your prompt.
Therefore, it is not possible to provide the detailed information requested in your prompt based on the provided text. The document serves as an FDA 510(k) submission summary, which typically focuses on demonstrating substantial equivalence rather than presenting granular study results that might be found in a clinical investigation report.
§ 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).