(60 days)
The Coronis Color 3MP 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 MDCC 3120-DL is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Coronis Color 3MP is a display system for medical viewing. It consists of 3 components: MDCC 3120-DL is a 20.8" color LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control.
The display system can be a single-head system or multi-head system. In the last case it ntains multiple displays and display controller boards.
The device consists of three components:
- . One 3-megapixel flat panel display (MDCC 3120-DL)
- . One 32-bit display controller (MXRT 5100 board)
- . MediCal QAWeb Agent software
The flat panel display has a resolution of 1536x2048 pixels. It can be used in landscape and portrait mode.
The MXRT 5100 display controller board is an ultra-high speed board with a 32-bit in, 32-bit out lookup table, providing up to 64 bit color.
The MediCal QAWeb Agent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.
This 510(k) summary does not contain the kind of detailed information about acceptance criteria and study results you are looking for.
This document is a 510(k) Summary which primarily focuses on demonstrating Substantial Equivalence (SE) to a previously cleared predicate device. For display systems like the Coronis Color 3MP, the SE process typically involves comparing technical specifications and intended use rather than performing extensive clinical studies as one might for a diagnostic AI algorithm.
Here's why the document doesn't have the information you're asking for:
- Device Type: This is a medical display system, not a diagnostic AI algorithm. The performance evaluation for a display focuses on technical characteristics (resolution, brightness, contrast, calibration) rather than diagnostic accuracy.
- 510(k) Process: The 510(k) pathway is for devices substantially equivalent to existing ones. It often doesn't require new clinical studies if the device's technical characteristics and intended use are similar enough to a predicate.
- Date: This document is from 2006. The standards and expectations for AI/ML performance evaluation in medical devices have evolved significantly since then.
Therefore, I cannot extract the information requested as it is not present in the provided text. The document clearly states: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy." This signifies that the primary "proof" relies on comparing the device's technical specifications to a cleared predicate rather than a separate clinical performance study with acceptance criteria.
§ 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).