(67 days)
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
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I am sorry, but the provided text does not contain the detailed information needed to fill out the table and answer all the questions about the acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device (Barco Mammo Tomosynthesis, MDMG-5221), which confirms that the device is substantially equivalent to a legally marketed predicate device.
While it mentions the device's indications for use (displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners, and specifically designed for breast tomosynthesis applications), it does not include:
- A table of acceptance criteria and reported device performance.
- Details about the study design, sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test or training sets.
- Information on MRMC studies, standalone performance, or the type of ground truth used.
This type of information is typically found in the 510(k) summary or the full submission, which is not provided in 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).