(41 days)
21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
MDL2118A (ME355i2) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (2048 x 1536) resolution for both landscape and portrait display.
The provided text is a 510(k) summary and FDA clearance letter for a monochrome LCD monitor. It details information about the device's classification, intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI-powered devices.
The medical device being discussed is a "21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2)," which is a display monitor for viewing medical images. This type of device does not typically undergo performance studies with acceptance criteria or ground truth as would an AI diagnostic algorithm. Its evaluation focuses on technical specifications (e.g., luminance, resolution, display quality) and adherence to regulatory standards for medical displays, rather than diagnostic accuracy against a ground truth.
Therefore, I cannot provide the requested information from the given text as it pertains to AI device studies.
§ 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).