(15 days)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a highresolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
The provided document describes a 510(k) submission for a medical image display system. It is a pre-market notification to establish substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the way a clinical trial for an AI diagnostic device would.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies is not applicable to this type of regulatory submission for a display system. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study.
Here's an attempt to extract relevant information and explain why other points are not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as performance metrics with numerical targets. For a display system like this, "acceptance criteria" likely refer to meeting performance specifications similar to the predicate device and relevant industry standards (e.g., DICOM, display luminance, contrast, resolution, uniformity). The document only states that the device contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device" and that the device will be manufactured "in accordance with voluntary and safety standards."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate device (CORONIS 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM, K013922) | Found to be substantially equivalent by FDA. |
| Compliance with voluntary and safety standards | Device will be manufactured in accordance with these standards. |
| Hazard analysis classifies potential hazards as Minor | Hazard analysis performed and classified potential hazards as Minor. |
| Functionality as a flat panel hi-resolution LCD monitor system for displaying medical images | System consists of LCD monitor and high-resolution graphic control board for image display. |
2. Sample size used for the test set and the data provenance
Not Applicable. This document describes a display system, not an AI or diagnostic device that would undergo testing with a "test set" of medical images for diagnostic performance evaluation. The "data" being referenced would be the technical specifications and performance data of the display itself, demonstrating its capabilities as a medical image display.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As above, there is no "test set" in the context of clinical ground truth for a display system.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable.
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. This device is a display system, not an AI or diagnostic tool. Therefore, no MRMC study, AI assistance comparison, or effect size is relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware display system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. For a display system, the "ground truth" would relate to its technical specifications (e.g., color accuracy, luminance uniformity, resolution, contrast ratios) as measured by calibrated instruments, rather than diagnostic "ground truth" on medical pathology. This information is not detailed in the summary.
8. The sample size for the training set
Not Applicable. This is a hardware display system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not Applicable.
§ 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).