(99 days)
OsiriX MD™ is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
The OsiriX MD software is an interactive image display and navigation program that was designed medical imaging modalities. It supports all types of images generated by variety of imaging equipment and scanners available today. It supports the DICOM standard for image communication as well as a variety of other image formats used in academic and research community. OsiriX MD is tailored for large sets of multidimensional and multi-modality images such as combined PET-CT studies that require three dimensional image fusion and volume rendering. The software is developed on a Macintosh platform taking advantage of the underlying UNIX kernel of the Mac OS X operating optimized 3D graphic capabilities of Open GL graphic standard that is widely used for computer games and animations and is highly optimized on the Macintosh platform for taking advantage of any hardware graphic accelerator boards that would be available. The software was developed in Objective-C in Apple Cocoa development environment. In the design of the software a special attention was given to adapt the user interface to navigating through large sets of image data. The graphical user interface also uses the Macintosh interface. Users can change and customize the software by adding and removing tools and items from the program toolbar and menu bars. This allows for adapting the software for number of functions and avoiding the users to be overwhelmed by an excessive number of unnecessary tools and functions that are not always needed.
I am sorry, but based on the provided text, there is no acceptance criteria or study information available to populate the requested tables and answer the questions.
The provided document is a 510(k) summary for the OsiriX MD device, which primarily focuses on establishing substantial equivalence to a predicate device (aycan Workstation OsiriX). It describes the device, its intended use, and technological characteristics.
The document explicitly states: "The 510(k) Pre-Market Notification for OsiriX MD contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, intended use, and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices."
This indicates that the submission relies on demonstrating similarity to an already approved device rather than presenting a de novo study with specific acceptance criteria and performance data for this particular device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the given text.
§ 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).