(74 days)
The MX50N(MX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
The document provided is a 510(k) premarket notification for a medical LCD monitor system (MX50N(MX50YQS)). This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information typically found in studies proving a device meets acceptance criteria for an AI/algorithm-based diagnostic device will not be present.
Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (MX50N(MX50YQS)) |
|---|---|---|
| Non-Clinical Performance Data (compared to predicate K052312) | ||
| LCD Panel Size | 21.3" (Predicate) | 21.3" |
| Resolution | 2560 × 2048 (Predicate) | 2560 × 2048 |
| Pixel pitch | 0.165mm x 0.165mm (Predicate) | 0.165mm x 0.165mm |
| Brightness | 1000cd/m² (Predicate) | 1200cd/m² |
| Contrast Ratio | 700 : 1 (Predicate) | 1000 : 1 |
| Input Signal | DVI-I (Predicate) | DVI-I, DisplayPort |
| Power Supply | 100~240 VAC, 50/60Hz (Predicate) | 100~240 VAC, 50/60Hz |
| Color/Monochrome | Monochrome (Predicate) | Monochrome |
| Compliance to Standards | ||
| IEC 60601-1 | General Requirements For Basic Safety And Essential Performance | Complies |
| IEC 60601-1-2 | Electromagnetic Compatibility - Requirements And Tests | Complies |
| Specific Performance Tests | ||
| Resolution | Acceptance criteria specified in standards | Met acceptance criteria |
| Luminance | Acceptance criteria specified in standards | Met acceptance criteria |
| Contrast | Acceptance criteria specified in standards | Met acceptance criteria |
| Noise | Acceptance criteria specified in standards | Met acceptance criteria |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission is for a medical monitor, not an AI/algorithm-based diagnostic device that processes image data for diagnosis directly. The "tests" mentioned are technical performance verifications of the display hardware (resolution, luminance, contrast, noise) against engineering specifications and international standards, not a diagnostic accuracy study on a dataset of patient cases.
- Data Provenance: Not applicable. The tests are technical assessments of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. Ground truth in the context of diagnostic interpretation by experts is not relevant for technical performance testing of a monitor. The "ground truth" here is the specified technical performance metrics and compliance with industry standards.
4. Adjudication Method for the Test Set
- Not applicable. There is no diagnostic interpretation or consensus needed for the technical performance tests of a monitor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device (a medical monitor) is not an AI algorithm that improves human reader performance. It is a display device for medical images. The submission focuses on its technical specifications and compliance with safety standards.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. The MX50N(MX50YQS) is a display device, not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, resolution, contrast, etc.) and compliance with electrical and safety standards.
7. Type of Ground Truth Used
- For the technical performance tests (resolution, luminance, contrast, noise), the "ground truth" or reference is established by specified acceptance criteria in international and consensus standards (e.g., IEC 60601-1, IEC 60601-1-2 and likely other display performance standards such as DICOM Part 14, though not explicitly listed as a test item in the summary).
8. Sample Size for the Training Set
- Not applicable. The MX50N(MX50YQS) is a hardware device (LCD monitor system) and not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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).