(58 days)
The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MeDis 5MP device is a digital image display system. The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System device consists of components to provide high resolution visualization of digital images.
This submission pertains to the Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System.
It's crucial to understand that this 510(k) summary is for a medical display system, not an AI algorithm or a diagnostic software. Therefore, the "acceptance criteria" and "study" described are focused on the display's performance characteristics for medical image viewing, rather than the diagnostic accuracy of an AI.
Given that context, here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific, quantifiable acceptance criteria or a dedicated study comparing the device against such criteria. This is common for display devices in this regulatory era, where the focus is on demonstrating substantial equivalence to existing predicate devices meeting general performance expectations for medical imaging.
Instead, the submission implies acceptance based on the device's technical specifications and its ability to meet the general requirements for "displaying and viewing digital images for review and analysis by trained medical practitioners." The comparison is primarily against predicate devices with similar intended uses and technological characteristics.
Therefore, the "acceptance criteria" can be inferred from the device's description and the general requirements for medical displays at the time. The "reported device performance" is essentially the specifications of the MeDis 5MP.
| Characteristic | Implied Acceptance Criteria (General for Medical Displays) | Reported Device Performance (Barco MeDis 5MP) |
|---|---|---|
| Resolution | High resolution for medical image visualization (e.g., capable of displaying 5 megapixels) | 5 MegaPixel |
| Intended Use | Capable of displaying and viewing digital images for review by trained medical practitioners | Intended to be displaying and viewing digital images for in used review by trained medical practitioners. |
| Technological Characteristics | Components to provide high resolution visualization of digital images | Consists of components to provide high resolution visualization of digital images. |
| Equivalence | Substantially equivalent to previously marketed medical display systems | Determined substantially equivalent to Barco NV/Display Systems, MWD 321 Medical Workstation Display, Barco MGD 521 (K972701), and others. |
2. Sample size used for the test set and the data provenance
N/A. This device is a display system, not an AI algorithm or a diagnostic software that would process a "test set" of medical data. Its performance is assessed through its hardware specifications and compliance with general display standards, often demonstrated through internal testing and comparisons to predicate devices. There is no mention of a "test set" of images for diagnostic performance evaluation in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As a display system, there is no "ground truth" to be established by experts related to the device's diagnostic performance. The ground truth concept is relevant for AI algorithms or diagnostic tools that interpret medical images.
4. Adjudication method for the test set
N/A. No test set or expert adjudication is described for a display system.
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
No. A MRMC comparative effectiveness study is designed to evaluate the impact of a diagnostic tool (like AI) on human reader performance. This submission is for a medical display system, not a diagnostic AI tool, so such a study would not be applicable or expected.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a hardware display system, not an algorithm. Standalone performance is relevant for software algorithms that operate independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. As explained, the concept of "ground truth" for diagnostic accuracy is not relevant to a medical display system itself. The device is evaluated on its ability to accurately render images, not to interpret or diagnose them.
8. The sample size for the training set
N/A. As a hardware medical display system, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
N/A. This question is not applicable for a medical display 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).