(75 days)
The Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Color Coronis 2MP is a digital image display system. The Color Coronis 2MP device consists of components to provide high resolution visualization of digital images.
The provided text describes a 510(k) premarket notification for the "Color Coronis 2MP Medical Flat Panel Display System". This document is a regulatory approval letter and summary, not a study report detailing performance against acceptance criteria. Therefore, most of the requested information regarding performance, sample sizes, expert qualifications, and study methodologies is not present in the provided text.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
The document does not specify quantitative acceptance criteria or report specific performance metrics for the device. Instead, it focuses on the device's substantial equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
Not specified in the provided text. The document refers to a "study" implicitly through the 510(k) process, but details of any specific clinical or technical test set are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a medical display system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a display system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not specified or applicable in the provided context for a display system.
8. The sample size for the training set:
Not applicable. As a display system, it does not typically involve a "training set" in the context of machine learning or diagnostic algorithms.
9. How the ground truth for the training set was established:
Not applicable for the reasons mentioned above.
In summary, the provided document is a regulatory approval for a medical display system based on substantial equivalence, not a detailed technical or clinical study report. Therefore, it does not contain the information requested regarding acceptance criteria, study methodologies, or performance metrics.
§ 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).