(114 days)
The Barco MeDis 2MP1NT Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MeDis 2MP1NT Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained practitioners.
The MeDis 2MP1NT device is a digital image display system.
The Barco MeDis 2MP1NT device consists of components to provide high resolution visualization of digital images.
The provided text is a 510(k) summary and FDA clearance letter for the Barco MeDis 2MP1NT Medical Diagnostic Display System. This document describes a medical display system, not an AI-powered diagnostic device, and therefore does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI.
The information provided pertains to the regulatory clearance of a medical device (a display system) and focuses on its substantial equivalence to a predicate device, its intended use, and its technological characteristics. It does not include:
- A table of acceptance criteria and reported device performance (in terms of AI metrics).
- Any details about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set, as these are relevant to studies evaluating diagnostic performance, typically for algorithms or new diagnostic methods.
- Information on MRMC comparative effectiveness studies with AI assistance.
- Details about standalone algorithm performance.
- The type or method of establishing ground truth for training or test sets.
- Training set sample size or how its ground truth was established.
In summary, the provided document is not about an AI device and does not offer the specific data points requested for such a system.
§ 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).