(15 days)
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.
The monitor combines a TFT(thin film transistor) liquid crystal display panel structure and a built-in backlight with inverter for a better picture quality. The monitor can be used in portrait or landscape version, simply by turning the panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. The image brightness can be adjusted by means of a control wheel on the monitor. The LCD panel adopts Super Fine TFT(SA-SFT) for the MD21GS-2MP-CB, BB and MD211GS2P-CB, BB. Additionally, a low reflection overcoat is applied on top of the bead layer, which yields a low, uniform reflection over the surface of the glass. This process also provides for a truer representation of black and a higher contrast ratio. The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB can select the use of the landscape or the portrait only by rotating the LCD panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle, In addition, because our device has the height adjustment function of the stand, a more ideal positioning can be offered.
The provided text does not contain information about acceptance criteria, device performance, or details of a study involving a test set, experts, or ground truth.
The document is a 510(k) premarket notification for a medical LCD monitor (NEC MD21GS-2MP-CB, MD21GS-2MP-BB, MITSUBISHI MD211GS2P-CB, MITSUBISHI MD211GS2P-BB). It establishes "Substantial Equivalence" to a predicate device (Barco Coronis 2MP Medical Flat Panel Display System, K023322).
The core of the submission focuses on:
- Device Description and Comparison: Detailing the technical specifications of the new monitor (e.g., LCD panel type, viewing angle, grayscale support, power supply, safety standards) and comparing them to the predicate device.
- Intended Use: Stating that the new monitor has the same intended use as the predicate: "displaying and viewing digital images for diagnosis by trained physicians." It explicitly excludes primary diagnostic use for mammography.
- Safety Standards: Highlighting that the new device meets a "severer safety standard" (UL60601) compared to the predicate (UL60950).
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, experts, or ground truth because this information is not present in the provided 510(k) summary.
The document is a regulatory submission for device classification and market clearance based on substantial equivalence, not a clinical study report. It indicates the device "provides support for improved diagnostic accuracy with simultaneous reproduction of up to 1024 from a palette of 3061 possible grayscales," but it does not provide study data to back up this claim in terms of meeting specific performance metrics or acceptance criteria through a formal study with human readers and ground truth.
§ 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).