(84 days)
The MX50TQS) 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 and breast tomosynthesis applications.
MX50T(MX50TQS) 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 provided text describes the WIDE Corporation's MX50T(MX50TQS) LCD monitor system, which is intended for displaying and viewing digital medical images for review and analysis by trained medical practitioners, specifically for digital mammography and breast tomosynthesis applications.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from Predicate Device) | Reported Device Performance (MX50T(MX50TQS)) |
|---|---|---|
| LCD Panel Size | 21.3" | 21.3" |
| Resolution | 2560 × 2048 | 2560 × 2048 |
| Pixel pitch | 0.165mm x 0.165mm | 0.165mm x 0.165mm |
| Brightness | 2,100cd/m² | 2000cd/m² |
| Contrast Ratio | 950:1 | 1000:1 |
| Input Signal | DVI-I | DVI-I, DisplayPort |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz |
| Color/Monochrome | Monochrome | Monochrome |
Note: The document states that the MX50T(MX50TQS) has "similar performance" for Brightness and Contrast Ratio compared to the predicate device, although the numerical values are slightly different. The acceptance criteria for these would likely be defined by a range that encompasses these values and demonstrates sufficient image quality for the intended use. The other listed parameters are either identical or the subject device offers an additional compatible input signal (DisplayPort), which expands functionality without compromising the predicate's capabilities.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "tests conducted for resolution, luminance, contrast and noise" without specifying the number of units or images tested.
- Data Provenance: Not explicitly stated. The non-clinical tests were conducted to comply with international and FDA-recognized consensus standards (IEC 60601-1 and IEC 60601-1-2). Given the manufacturer's location (Republic of Korea), it's likely the testing was performed there or by a recognized testing facility. The data provenance is non-clinical, related to electrical safety and performance characteristics of the monitor itself, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical studies were performed. The "ground truth" for this device relates to its technical specifications and adherence to safety and performance standards for a medical display.
4. Adjudication method for the test set:
- Not applicable as no clinical studies were performed requiring expert adjudication of patient data. The "adjudication" for this type of device would involve verifying that the physical measurements and tests meet the specified technical criteria in the standards.
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 MRMC or comparative effectiveness study involving human readers or AI was performed. The device is a medical display, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a medical monitor, not an algorithm. Its performance is evaluated based on its physical characteristics and adherence to technical standards for displaying medical images.
7. The type of ground truth used:
- The "ground truth" for the non-clinical tests consisted of the established requirements and specifications outlined in the international and FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and likely other display performance standards implicitly referenced by the tests for resolution, luminance, contrast, and noise). This is a technical, rather than a clinical, ground truth.
8. The sample size for the training set:
- Not applicable. This device is an LCD monitor, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this device does not utilize a training set.
Summary of the Study Proving Acceptance Criteria are Met:
The study proving the device meets its acceptance criteria is a non-clinical performance and safety testing study.
- Study Design: The manufacturer conducted tests to evaluate the device's technical specifications and adherence to relevant safety and performance standards.
- Tests Performed:
- Safety Tests: Compliance with IEC 60601-1 (General Requirements For Basic Safety And Essential Performance) and IEC 60601-1-2 (Electromagnetic Compatibility).
- Performance Tests: Evaluation of resolution, luminance, contrast, and noise.
- Results and Conclusion: "The tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards." and "Additionally, the safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through tests for resolution, luminance, contrast and noise." The overall conclusion is that the MX50T(MX50TQS) "meets the acceptance criteria and is adequate for this intended use."
In essence, the "study" for this medical display is a series of engineering and electrical tests demonstrating that the monitor physically performs as expected according to its technical specifications and meets the regulatory safety and electromagnetic compatibility requirements for medical electrical equipment. No clinical data or human-in-the-loop studies were deemed necessary due to the nature of the device (a display monitor).
§ 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).