(46 days)
20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
CDL2114A (DV3MC-HB) is a 20.8-inch color LCD monitor that supports a DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
The provided document is a 510(k) summary for a medical display monitor (TOTOKU ELECTRIC CO., LTD. 20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB)). This document does not contain information about acceptance criteria for an AI/algorithm-based device, nor does it describe a study proving such a device meets acceptance criteria.
The device in question is a display monitor, which is a hardware component. Its substantial equivalence is based on comparisons to a predicate device in terms of physical characteristics (e.g., LCD panel brightness, lifetime, AC adapter capacity), not on algorithmic performance or clinical outcomes.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance because the provided text is for a hardware display monitor, not an AI/algorithm-based medical device that would typically have such 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).