(23 days)
The display is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is especially designed for breast tomosynthesis (3D mammography) applications, breast MRI and breast US. It is especially designed for CT and ultrasound including vascular and gynaecological US.
The Coronis OneLook® (MDMC-32133) is a medical computer display designed for general radiology, mammography and tomosynthesis applications. The device can also be used for home reading in radiology.
The display is a high-resolution LCD monitor with improved technical chat are important for accurate medical image review: high luminance, good luminance ratio and luminance ratio and luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightne of the display, noise-free images (=good luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and guidelines. These technologies help the radiologist to make a swift and accurate diagnosis.
The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant.
The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays:
- SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView.
-AAM – Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the hightness
These applications are addressed by the general term 'Intuitive Workflow Tools'. The integration of the Intuitive Workflow Tools with the displays have been de-risked, verified and validated to ensure that they do not affect the safety and effectiveness of the displays.
The display can be used with or without the Barco MXRT display controller boards. The display controller board is installed in a PACS workstation computer, connected to the display can optionally be used with a touchpad, which is a controlling device (e.g. like a mouse or trackball) that makes it easier to work with diagnostic images and to use the IWTs.
The provided text describes a 510(k) premarket notification for a medical display device, Coronis OneLook (MDMC-32133). The document primarily focuses on demonstrating substantial equivalence to a predicate device (MDMC-12133, Coronis Uniti) through bench testing of technical characteristics.
Here is an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines a series of performance bench tests conducted on the MDMC-32133 in comparison to the MDMC-12133, referencing the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (2022). The text generally states that the MDMC-32133 has "similar characteristics" and "did not reveal new issues of safety and performance." However, it does not provide specific numerical acceptance criteria or detailed quantitative reported performance values for each characteristic. Instead, it concludes equivalence based on these test outcomes.
| Acceptance Criteria (Bench Test Category) | Reported Device Performance (MDMC-32133 vs. MDMC-12133) |
|---|---|
| Spatial resolution – MTF | Similar characteristics; no new safety/performance issues. |
| Pixel defects (Maximum counts, allowed defect types, and locations) | Similar characteristics; no new safety/performance issues. |
| Artifacts | Similar characteristics; no new safety/performance issues. |
| Temporal Response | Similar characteristics; no new safety/performance issues. |
| Luminance (maximum, minimum, achievable and recommended) | 1200 Nit Calibrated light output (MDMC-32133) compared to 1000 Nit (MDMC-12133). Overall similar characteristics; no new safety/performance issues. |
| Luminance response | Similar characteristics; no new safety/performance issues. |
| Conformance to DICOM GSDF | Similar characteristics; no new safety/performance issues. |
| Angular Dependency of Luminance | Similar characteristics; no new safety/performance issues. |
| Luminance uniformity or Mura test (Luminance & Chromaticity Uniformity) | Similar characteristics; no new safety/performance issues. |
| RMS (image variance) for multiple video levels | Similar characteristics; no new safety/performance issues. |
| Stability of luminance and chromaticity response with temperature and time of operation or on-time | Similar characteristics; no new safety/performance issues. |
| Spatial noise | Similar characteristics; no new safety/performance issues. |
| Reflection coefficient Display Reflectance incl. Specular and Diffuse coefficients | Similar characteristics; no new safety/performance issues. |
| Veiling glare or small-spot contrast | Similar characteristics; no new safety/performance issues. |
| Color tracking (primary colors and color gamut) | Similar characteristics; no new safety/performance issues. |
| Gray tracking (gray shaded and color gamut) | Similar characteristics; no new safety/performance issues. |
| EMC and Safety Standards Compliance | Compliant. |
| Environmental Tests (climate, mechanical, software) | Passed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "performance bench tests" that were performed. This implies testing on physical units of the device. It does not specify the sample size (number of devices tested) for these bench tests. The data provenance is not explicitly mentioned as retrospective or prospective in the context of data used for testing, but rather refers to the device characteristics under comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable as the study described is purely a technical bench test comparison of display performance, not a study involving human interpretation of medical images or establishment of ground truth for medical diagnoses.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal testing or clinical testing has been performed." The study focuses on technical characteristics of the display itself, not on the effectiveness of human readers using the display for diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable in the context of an algorithm's performance, as the device is a medical display, not an AI algorithm. The performance evaluation is for the display's technical specifications.
7. The Type of Ground Truth Used:
The "ground truth" for this type of test is typically established by industry standards and specifications for display performance, as well as the performance of the legally marketed predicate device (MDMC-12133). The tests are designed to measure intrinsic physical properties of the display hardware against these established benchmarks.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a display hardware, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information 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).