(42 days)
The Coronis 2MP 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 MDCG 2121-CB 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.
Coronis 2MP is a display system for medical viewing. It consists of 3 components:
MDCG 2121-CB is a 21.3" grayscale LCD display. BarcoMed Coronis PCIe 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 2-megapixel flat panel display (MDCG 2121-CB)
. One 10-bit display controller (BarcoMed Coronis PCIe board)
. MediCal QAWeb Agent software
The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape and portrait mode.
The BarcoMed Coronis PCIe display controller board is an ultra-high speed board with a 10-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray.
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) submission (K061926) for the Barco Coronis 2MP is a substantial equivalence claim to a predicate device (Coronis 2MP-21", K052403). Therefore, it does not present a standalone study with acceptance criteria and device performance as would be seen in a de novo submission. Instead, the submission focuses on demonstrating that the new device has "substantially equivalent" characteristics to the predicate device, implying that the acceptance criteria met by the predicate device are implicitly met by the new device.
The document states: "Any difference between both devices does not affect safety or efficacy." This suggests that the performance of the new device is expected to be maintained at a level equivalent to the predicate, which FDA had previously cleared.
Here's an breakdown based on the provided text, addressing your questions to the best of my ability given the nature of a substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence, the document does not explicitly state specific acceptance criteria or report a formal study showing device performance against those criteria in the way a new device might. Instead, the "acceptance criteria" are implied to be the performance and safety characteristics of the predicate device (Coronis 2MP-21", K052403). The "reported device performance" is the statement that the new device's basic specifications and functions are the same as the predicate.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Coronis 2MP) |
|---|---|
| Functionality as a medical display system for viewing digital images (excluding mammography). | Functions as a display system for medical viewing. |
| Resolution of 1600x1200 pixels. | Flat panel display has a resolution of 1600x1200 pixels. |
| 10-bit color depth (or grayscale equivalent). | 10-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray. |
| Ability to be used in landscape and portrait modes. | Can be used in landscape and portrait mode. |
| Features for display function, test patterns, calibration, and QA control. | MediCal QAWeb Agent software allows setting display function, display test patterns, calibrating the display, and viewing additional display controller information. |
| Safety and efficacy equivalent to the predicate device. | "Any difference between both devices does not affect safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document because a specific clinical or performance evaluation "test set" in the traditional sense was not performed for this substantial equivalence submission. The comparison is primarily based on the technological characteristics and specifications of the new device against the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. Ground truth establishment by experts is typically part of studies involving diagnostic performance, which is not the focus of this 510(k) for a display system. The "ground truth" here is essentially the established performance and safety of the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable/provided as there was no formal "test set" and expert adjudication described in the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic impact of AI or new imaging techniques on human readers, which is not the purpose of this display system 510(k). The device itself is a display, not a diagnostic algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study in the context of an algorithm or diagnostic tool was not done. The device is a display system, not an algorithm. Its performance is evaluated based on its technical specifications and functionality as a display.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence claim is the established performance and safety characteristics of the predicate device (Coronis 2MP-21", K052403). The new device is compared against these known characteristics to demonstrate equivalence.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. Display systems typically do not involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing processes are likely guided by engineering specifications and industry standards.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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).