(20 days)
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 and digital breast tomosynthesis 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 provided text describes a 510(k) premarket notification for the MX50N(MX50YQS) LCD Monitor System, which is intended for displaying and viewing digital medical images, specifically for digital mammography and digital breast tomosynthesis applications. The submission aims to demonstrate substantial equivalence to a predicate device (K160326).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the compliance with international standards. The performance metrics are a direct comparison between the subject device and the predicate device.
| Parameter | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (MX50N(MX50YQS)) |
|---|---|---|
| Intended Use | Same as predicate | Same as predicate |
| Technological Characteristics | Same as predicate | Same as predicate |
| Response Time (Typical) | 25ms (On/Off) | 25ms (On/Off) |
| LCD Panel Size | 21.3" | 21.3" |
| Resolution | 2560 x 2048 | 2560 x 2048 |
| Pixel Pitch | 0.165mm x 0.165mm | 0.165mm x 0.165mm |
| Brightness | 1200cd/m² | 1200cd/m² |
| Contrast Ratio | 1200 : 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 regarding "Acceptance Criteria": For the parameters where the subject device’s performance is directly aligned with the predicate (e.g., Response Time, LCD Panel Size), the predicate's performance acts as the de facto acceptance criterion for demonstrating substantial equivalence. For parameters with slight differences (like Contrast Ratio), the acceptance is based on the argument that the difference is not critical.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a test set in the traditional sense of a dataset for evaluating an AI algorithm. This device is a display monitor, not an AI diagnostic tool that processes clinical data.
Therefore, this information is Not Applicable in the context of this device and submission. There is no mention of clinical data or patient samples being used for testing. The testing performed is non-clinical, related to the display's technical specifications and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
As there is no "test set" of clinical data to establish ground truth for this display monitor, this information is Not Applicable.
4. Adjudication Method for the Test Set
As there is no "test set" of clinical data, this information is 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
No MRMC study was conducted. This device is a display monitor, not an AI algorithm intended to assist human readers directly or to be evaluated for its impact on reader performance.
Therefore, this information is Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm, but a hardware display monitor. Thus, a standalone algorithm performance study is Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth in the clinical sense (expert consensus, pathology) is Not Applicable, as this is a display monitor and not an AI diagnostic algorithm. The "ground truth" for the device's technical performance is established by the specifications and measurements according to recognized engineering and medical device standards.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This device is a display monitor, not a machine learning model.
Therefore, this information is Not Applicable.
9. How the Ground Truth for the Training Set was Established
As no training set is applicable, this information is Not Applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a non-clinical performance evaluation and compliance testing against recognized international standards and a comparison to a legally marketed predicate device.
- Type of Study: Non-clinical (bench testing, technical specification validation, standard compliance). No clinical studies were considered necessary or performed.
- Methodology:
- Substantial Equivalence Comparison: The MX50N(MX50YQS) was directly compared, parameter by parameter, with the predicate device (5MP Monochrome LCD Monitor MS55i2, K160326). This comparison covered intended use, technological characteristics, and various technical specifications (response time, LCD panel size, resolution, pixel pitch, brightness, contrast ratio, input signal, power supply, color/monochrome). The conclusion was that the devices were substantially equivalent, with any differences (e.g., contrast ratio) not adversely affecting the device's use.
- Compliance with Consensus Standards: The device underwent testing to comply with the following international and FDA-recognized consensus standards:
- IEC 60601-1: Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance.
- IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- Performance Metrics Evaluated: Tests were conducted for resolution, luminance, contrast, and noise.
- Conclusion: The results of these tests demonstrated that the MX50N(MX50YQS) met the acceptance criteria specified in the standards and was adequate for its intended use. The device was found to be as safe and effective as the predicate device.
In essence, the "study" is a comprehensive engineering and electrical safety validation against established industry benchmarks and a direct side-by-side technical comparison with a cleared 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).