(41 days)
21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) 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.
21.3-inch Monochrome LCD monitor that supports DVI video signal and provides QXGA (1536 X 2048) resolution for both landscape and portrait display.
The provided text is a 510(k) summary for a medical display monitor (TOTOKU 21.3-inch Monochrome LCD Monitor MDL2115A). This type of device is a display for medical images, not an AI/ML algorithm or diagnostic software that performs analysis or makes decisions.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) does not apply to this specific device.
The 510(k) summary for a display monitor focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing technical specifications (e.g., resolution, display technology, intended use) and conformity to relevant standards (e.g., DICOM Part 14 for grayscale display function, IEC standards for safety). There's no clinical performance study involving diagnostic accuracy, sensitivity, or specificity as there would be for an AI-powered diagnostic tool.
The summary states:
- Intended Use: "21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography."
- Substantial Equivalence: "MDL2115A (ME353i) (DV3MM-HB) (ME353iM) has almost the same characteristics as TOTOKU's predicate device MDL2110A (K050485) except for a LCD panel, an inverter and chassis."
The "acceptance criteria" for such a device would typically relate to its technical performance matching or exceeding the predicate device and meeting relevant industry standards for medical displays. This would involve measurements of luminance, contrast, resolution, noise, and compliance with the DICOM Part 14 standard for grayscale display function, but not clinical performance metrics tied to patient outcomes or expert diagnoses.
§ 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).