(50 days)
CMS-View provides a means for the playback and/or review of medical images or imaging sequences by physicians, scientists or other medical personnel. These medical images may originate from different imaging modalities (x-ray, MRI, ultrasound, nuclear, etc.) and are inpul to the CMS-VIEW system via industry standard formats (DICOM) or by creating a digital equivalent of a video-format (via frame-grabber). Standard image review tools are provided, including zoom, brightness and contrast controls.
The review of medical images is suitable for use by physicians and scientists in the following applications:
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Scientific and research studies, selecting and assessing medical images that are of interest,
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Review and analysis of patient medical images, providing physicians and administrators with convenient access and review features/capabilities.
CMS-View is a professional state-of-the-art DICOM Review Station, designed for use with Microsoft Windows operating systems (preferably, Windows NT). CMS-View facilitates the import and visualization of medical images from a range of different image sources (DICOM-CD, network, VCR, etc.) for use by trained medical personnel (technologists, radiologists, other physicians, etc.). CMS-View may be used either independently or in conjunction with other software products from MEDIS.
I am sorry, but based on the provided document, I cannot extract the detailed information requested regarding the acceptance criteria, study design, and performance metrics.
The document is a 510(k) summary for the "CMS - View" device, which is described as a DICOM Review Station for medical image visualization. It outlines the device's intended use and claims substantial equivalence to a predicate device (RadWorks Medical Imaging Software).
However, the provided text does not contain any information about:
- Specific acceptance criteria or reported device performance metrics. The document states that "Potential hazards are controlled by a risk management plan for the software development process (see Appendix C), including hazard analysis, verification and validation tests and evaluations by hospitals," but it does not detail the results or criteria used in these tests.
- Sample size used for the test set or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a performance study with detailed clinical or technical endpoints. It confirms the FDA's clearance of the device based on this substantial equivalence claim.
§ 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).