(116 days)
The NIO 2MP LED Display (MDNC-2221) is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Nio Color 2MP (MDNC-2221)
The provided text is a 510(k) premarket notification letter from the FDA to Barco N.V. regarding their Nio Color 2MP display. This document does not contain information about the acceptance criteria for a device's performance or a study proving it meets those criteria.
The letter is primarily a regulatory approval document, stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for displaying and viewing digital images by trained medical practitioners (excluding primary image diagnosis in mammography). It outlines the regulatory classification, applicable regulations, and general controls the manufacturer must adhere to.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present.
§ 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).