(32 days)
The MDNC-3121 Medical Flat Panel Display System 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. The MDNC-3121, which is part of the Nio Color 3MP system, will be marketed separately.
Nio Color 3MP (MDNC-3121) Medical Flat Panel Display System
This document is a 510(k) clearance letter from the FDA for a medical display monitor (Nio Color 3MP). It does not contain information about acceptance criteria or a study proving that a device (specifically an AI/algorithm-based diagnostic device) meets such criteria.
The information requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, training set details) is typically found in clinical study reports or scientific publications that support the efficacy and safety of an algorithm-based medical device. This document concerns hardware (a display monitor) and its substantial equivalence to previously marketed devices, based on its intended use as a display for reviewing digital images, not for primary image diagnosis in mammography.
Therefore, I cannot extract the requested information from the provided text.
§ 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).