(68 days)
The Nio 2MP Medical Grayscale Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The Nio 2MP device is a digital image display system. The Barco Nio 2MP device consists of components to provide high resolution visualization of digital images.
The provided document is a 510(k) summary for the Barco Nio 2MP Medical Grayscale Display System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document is a regulatory approval letter and a summary of the device for submission to the FDA. It declares the device substantially equivalent to a previously approved device. This type of submission rarely includes detailed performance studies like those one would expect for a diagnostic AI device.
Therefore, I cannot fulfill your request for the tables and information related to acceptance criteria and study details based on the provided text. The document simply serves as official notification of FDA clearance.
§ 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).