(64 days)
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X-ray or MRI, etc.
51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is a display for medical use.
The provided text describes a 510(k) submission for a medical monitor and does not contain information about acceptance criteria or a study proving its performance against such criteria. The submission is a premarket notification for a new medical device, the IIYAMA CORPORATION 51cm (20.1 inch) TFT Monochrome LCD Monitor (MU5111BW), seeking substantial equivalence to a predicate device, the EIZO NANAO RadiForce G21 (K024358).
Therefore, I cannot provide the requested information about acceptance criteria or a study because the provided text does not contain this information.
The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against specific acceptance criteria from a primary clinical or technical study, as would be expected for a novel AI/software device or a device with new performance claims.
The comparison in the document is primarily a feature-by-feature comparison of technical specifications between the proposed device and the predicate device to argue for substantial equivalence in design and intended use. Performance testing, if conducted, would typically be to ensure the device meets its own specifications (e.g., brightness, contrast, resolution) which are then compared to the predicate, but specific "acceptance criteria" and a "study proving it meets them" in the context of clinical performance (like diagnostic accuracy) are not detailed here.
§ 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).