(141 days)
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, Vitrea 4DCT has the following indication:
The Vitrea 4DCT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extend of cerebral perfusion disturbances.
The Vitrea system is a medical diagnostic device that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea system user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- Retrieve image data over the network via DICOM .
- Display images that are automatically adapted to exam type via dedicated protocols .
- Select images for closer examination from a gallery of up to six 2D or 3D views .
- Interactively manipulate an image in real-time to visualize anatomy and pathology .
- Annotate, tag, measure, and record selected views .
- Output selected views to standard film or paper printers, or post a report to an intranet . Web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server .
The provided text does not contain detailed information about specific acceptance criteria or an explicit study proving detailed device performance against those criteria. The document appears to be a 510(k) summary for a medical image processing software (Vitrea® 4DCT), outlining its general description, intended use, and substantial equivalence to a predicate device. While it states the device "allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images," it doesn't provide quantifiable metrics related to its performance nor does it describe specific studies with acceptance criteria for those metrics.
Therefore, I cannot populate the requested tables and sections with the information about acceptance criteria, detailed device performance, sample sizes, ground truth establishment, or specific study types (MRMC, standalone without human-in-the-loop).
The document primarily focuses on:
- Device identification and classification: Trade name, common name, classification, predicate device.
- General device description: Capabilities like retrieving, displaying, manipulating, annotating, and outputting images.
- Intended Use: For processing, review, analysis, communication, and media interchange of multi-dimensional digital images, specifically mentioning the 4DCT Brain Perfusion option for visualizing apparent blood flow and pictorial illustration of perfusion-related parameters to aid in assessing cerebral perfusion disturbances.
- Predicate Device Comparison: General statement of similarity in analysis, communication, and media interchange of digital images, and DICOM protocol support.
- FDA Communication: A letter from the FDA confirming substantial equivalence to a predicate device.
To address your request fully, a different type of document (e.g., a clinical study report, a detailed V&V report, or specific performance testing data) would be needed that explicitly defines acceptance criteria and presents quantitative results from studies designed to meet those criteria.
§ 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).