(242 days)
MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.
MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
The provided text is related to a 510(k) premarket notification for a medical monitor (MX50N), not an AI/ML medical device. Therefore, much of the requested information (such as AI model performance, training/test sets, expert adjudication, MRMC studies, etc.) is not applicable or available in this document.
The document discusses the technical specifications, intended use, and non-clinical testing of the MX50N monitor, comparing it to a predicate device. The "acceptance criteria" here refer to the device meeting specific technical standards and performance metrics for medical display devices, rather than an AI model's diagnostic accuracy.
Given this limitation, I will extract and present the relevant information, while noting when the requested details are not applicable to this type of device and application.
Description of Acceptance Criteria and Study Proving Device Meets Criteria for the MX50N Medical Monitor
The MX50N is a medical display monitor intended for displaying digital medical images, specifically for mammography and digital breast tomosynthesis applications. The acceptance criteria for this device are based on its technical performance and compliance with relevant medical device standards, ensuring it can accurately display medical images for review and analysis by trained practitioners.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a medical monitor like the MX50N are based on established performance characteristics for display devices in diagnostic radiology. The reported device performance is demonstrated through bench testing against these characteristics.
| Acceptance Criteria / Performance Metric | Predicate Device (MX50N(MX50YQS)) Performance | Subject Device (MX50N) Performance | Discussion of Differences / Meeting Criteria |
|---|---|---|---|
| Product Name | MX50N(MX50YQS) | MX50N | - |
| Intended Use | Displaying and viewing digital medical images for review and analysis by trained medical practitioners; specifically for digital mammography and digital breast tomosynthesis. | Same | Same intended use, indicating substantial equivalence in core function. |
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | Meets the same standard. |
| LCD Panel Size | 21.3" | 21.3" | Same physical size. |
| Resolution | 2560 x 2048 | 2560 x 2048 | Same high resolution for diagnostic imaging. |
| Pixel Pitch | 0.165 mm x 0.165mm | 0.165 mm x 0.165mm | Same pixel density. |
| Maximum Luminance | 1,200 cd/m2 | 3,000 cd/m2 | Improved performance; provided by the panel manufacturers, indicating enhanced brightness which can be beneficial for image display. |
| Contrast Ratio | 1000 : 1 | 2000 : 1 | Improved performance; provided by the panel manufacturers, indicating better distinction between light and dark areas. |
| Input Signal | DVI-I, DisplayPort | DVI-I, DisplayPort | Same connectivity. |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz | Same power requirements. |
| Color/Monochrome | Monochrome | Monochrome | Consistent as a monochrome display for medical imaging. |
| Firmware Version | N1220_221229 | N1220_221229 | No change, indicating software stability and proven functionality. |
| QC Software | Lumical Advanced | EzCal | Different software names, but functions are reported to be similar, indicating continued capability for quality control. |
| Luminance Non-uniformity Compensation | Luminance Uniformity Correction | Luminance Uniformity Correction | Consistent feature ensuring uniform brightness across the display. |
| Sensors | Backlight Sensor, IQ Sensor, Ambient Light Sensor | Backlight Sensor, IQ Sensor, Ambient Light Sensor | Consistent features for maintaining optimal display conditions. |
| USB Ports / Standard | 1 upstream, 3 downstream / Rev. 3.0 | 1 upstream, 3 downstream / Rev. 3.0 | Same connectivity. |
| Dimensions (w stand) | 390.3 x 520.1 x 248.8 mm | 390.3 x 520.1 x 248.8 mm | Same physical dimensions. |
| Safety and Effectiveness | Demonstrated via standards compliance and comparison to predicate device. | Demonstrated via standards compliance and comparison to predicate device. | Compliance with IEC 60601-1 and IEC 60601-1-2 standards and specific bench tests (Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF). |
The key improvements in the subject device (MX50N) over the predicate are in Maximum Luminance and Contrast Ratio, both of which are critical performance aspects for medical displays, especially for mammography.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a medical monitor, not an AI/ML algorithm that processes patient data. The "test set" here refers to the physical monitor itself undergoing bench testing, not a dataset of medical images.
- Sample Size for Test Set: Not applicable in the context of data. The "sample" is the physical device unit(s) subjected to testing.
- Data Provenance: Not applicable. The testing verifies the physical and electrical performance of the monitor.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for a medical display monitor is its adherence to technical specifications and industry standards for image display. This is verified by objective bench tests and compliance with recognized consensus standards (e.g., DICOM Part 14 GSDF, IEC 60601 series). No human experts are used to establish "ground truth" in this context.
4. Adjudication Method for the Test Set
Not applicable. This is a technical performance verification, not a clinical study involving interpretation or adjudication of diagnostic findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These studies are typically performed for CAD or AI-assisted diagnostic devices to evaluate their impact on human reader performance. For a medical monitor, the effectiveness is demonstrated by its ability to accurately and consistently display images according to established standards.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No, this is not applicable. The device is a display monitor, not an algorithm. Its performance is inherently linked to human interaction (a medical practitioner viewing images on it).
7. The Type of Ground Truth Used
The "ground truth" for this device is compliance with:
- Technical Specifications: The monitor's ability to meet its stated performance characteristics (e.g., resolution, luminance, contrast, response time).
- Industry Standards: Adherence to recognized consensus standards like DICOM Part 14 GSDF for grayscale display function, and IEC 60601 series for medical electrical equipment safety and essential performance.
- Predicate Device Equivalence: Demonstrating that its performance is substantially equivalent to, or improved upon, that of a legally marketed predicate device.
This "ground truth" is established through engineering verification and validation (bench testing) against these objective standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/ML algorithm that requires ground truth for a training set.
§ 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).