(41 days)
21.3 inch (53cm) Monochrome Digital Mammography 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently. MS51i2 (MDL2123A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
MS51i2 (MDL2123A) is a 21.3-inch (53 cm) monochrome LCD monitor whose display resolution is 2048 x 7680 (landscape), 7680 x 2048 (portrait) supporting DVI (digital visual interface).
The provided text is a 510(k) summary for a medical display monitor (TOTOKU ELECTRIC CO., LTD. MS51i2). It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way that would be expected for an AI/CADe device.
This document is a regulatory submission for a display monitor, which is a hardware component. Its performance is assessed differently than a software algorithm that performs analysis or detection. The key aspects of this submission revolve around demonstrating that the new monitor is substantially equivalent to an existing, legally marketed monitor, primarily focusing on hardware specifications and intended use.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance from this document, nor can I provide information on various study design elements (sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set specifics) because these types of studies are not typically conducted or described for a display monitor's 510(k) submission.
The 510(k) process for this device focuses on demonstrating that the monitor performs as expected for displaying medical images, not on its ability to interpret or detect findings. The acceptance criteria for such a device would likely pertain to display characteristics (resolution, brightness, contrast, color accuracy, uniformity), and testing would involve measurements against established standards (e.g., DICOM Part 14 calibration). This document does not detail those specific acceptance criteria or performance test results.
§ 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).