(43 days)
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing.
DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.
Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Analysis: Allows the visualization of vascular morphology from MR images.
3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.
DC Neuro is a software package available for viewing, printing, storing, transferring, and quantifying DICOM magnetic resonance imaging (MRI) studies. The DC Neuro software is able to run on "off the shelf" standard PC components using the Microsoft Windows XP Professional Operating Software.
DC Neuro provides both analysis and viewing capabilities that integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
DC Neuro software provides automated processing of DICOM images. Imaging cxams are transferred to the DC Neuro system in DICOM format either directly from the MR system or from a picture archiving and communications system (PACS) or via supported digital media. The DC Neuro system reads the incoming image headers and automatically sorts the images into exams consisting of multiple data sets. Pre-set processing algorithms may be performed on the incoming data as defined by the user such as image co-registration, fMRI analysis, diffusion analysis, dynamic analysis, vessel analysis, and 3D displays.
DC Neuro is a software package that uses standard PC hardware, with a standard uscr/operator interface (keyboard and mouse), and a standard Operating System: Microsoft Windows XP Professional.
The provided text is a 510(k) summary for the Invivo Corporation's DC Neuro device. It outlines the device's functions, intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information about a study proving the device meets specific acceptance criteria.
The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against pre-defined acceptance criteria. The document states: "No new hazards are introduced by Invivo Corporation's DC Neuro, as compared to predicated devices and image processing functionality," and concludes that "Invivo Corporation's DC Neuro is substantially equivalent to the Philips ViewForum 2003 workstation, and the Philips BOLD fMRI. Diffusion/Fiber Tracking, Dynamic and Vessel Analyses, and 3D visualization image processing functionality."
Therefore, based solely on the provided text, I cannot complete the requested tables and answer the questions related to acceptance criteria and a study proving their fulfillment. The information necessary to do so is absent from this 510(k) summary.
In summary, the provided document does not include:
- A table of acceptance criteria or reported device performance against such criteria.
- Information about sample sizes for test sets or data provenance.
- Details about the number or qualifications of experts used for ground truth.
- Adjudication methods for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
- A standalone (algorithm only) performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for the training set.
- How the ground truth for the training set 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).