(134 days)
Monochrome LCD Monitors intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specified by the manufacturer of the system.
Monochrome LCD Monitors (MM 20, MM 30 and MM 50) are used to display images such as X-ray, or MRI images. These models have resolutions of: 2560 X 2048, 2048 X 1536 and 1600 X 1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by Gretagmacbeth. These models are certified to the EN 60601-1 medical safety standard. The monitors use universal switching power supplies compatible with AC100V-120V/200V-240V ,50/60Hz. The graphics card needed for the personal computer is the VREngine MD/SMD Series. The monitors may be deployed in the portrait or the landscape position.
The provided text describes a medical device, the "Lumimed Monochrome LCD Monitor" (Models: MM 20, MM 30, MM50), and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against pre-defined acceptance criteria.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific acceptance criteria or report performance data as would be typically seen for a new algorithmic device. Instead, it aims to demonstrate "substantial equivalence" of the Lumimed Monochrome LCD Monitors to a predicate device, the RadiForce G51, 5 Megapixel Monochrome LCD Monitor (K042755). The comparison table below highlights features and specifications rather than direct performance metrics against acceptance criteria.
| Feature/Metric | Acceptance Criteria (Predicate Device) - RadiForce G51 | Reported Device Performance - Lumimed MM20 | Reported Device Performance - Lumimed MM30 | Reported Device Performance - Lumimed MM50 |
|---|---|---|---|---|
| 510(k) Number | K042755 | New | New | New |
| Manufacturer | Eizo Nano Corporation | Heeyoung Co., Ltd | Heeyoung Co., Ltd | Heeyoung Co., Ltd |
| Panel Size and Type | 21.3" TFT monochrome LCD display | 21.3" TFT monochrome LCD display | 21.3" TFT monochrome LCD display | 20.1" TFT monochrome LCD display |
| Pixel Pitch | 0.165mm x 0.165mm | 0.270mm x 0.270mm | 0.2115mm x 0.2115 | 0.156mm x 0.156mm |
| Native Resolutions | 2048x2560 (portrait), 2560x2048 (landscape) | 1200x1600 (portrait), 1600x1200 (landscape) | 1536x2048 (portrait), 2048x1536 (landscape) | 2048x2560 (portrait), 2560x2048 (landscape) |
| Brightness | 700 cd/m2 | 1000 cd/m2 | 900 cd/m2 | 850 cd/m2 |
| Contrast Ratio | 600:1 | 700:1 | 700:1 | 600:1 |
| Dot Clock | 152 MHz | 125 MHz | 130 MHz | 162 MHz |
| Serial Ports | Mini DIN 4pin (Remote In), Mini DIN 8pin (Remote Out) | Mini DIN 4pin (Remote In), Mini DIN 8pin (Remote Out) | Mini DIN 4pin (Remote In), Mini DIN 8pin (Remote Out) | Mini DIN 4pin (Remote In), Mini DIN 8pin (Remote Out) |
| Active Display Size (HxV) | 337.9 x 422.4mm | 432(H) x 324(V) | 432(H) x 324(V) | 399(H) x 319(V) |
| Luminance Calibration | Software (Optional), Photo-sensor (Optional) | Software (Optional), Photo-sensor (Optional) | Software (Optional), Photo-sensor (Optional) | Software (Optional), Photo-sensor (Optional) |
| Power | AC 100V-120V / 200V-240V, 50/60Hz | AC 100V-120V / 200V-240V, 50/60Hz | AC 100V-120V / 200V-240V, 50/60Hz | AC 100V-120V / 200V-240V, 50/60Hz |
Note: The acceptance criteria for these monitors are implied to be "substantially equivalent" to the predicate device, meaning their specifications and intended use do not raise different questions of safety and effectiveness. The document also states that "Testing was performed according to internal company procedures and the monitors were safety certified."
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This is a submission for a display monitor, not an AI/algorithm-based diagnostic device that would typically use a test set of medical cases. The "test set" in this context refers to the monitor units themselves undergoing technical and safety testing. The document does not specify a sample size for these units.
The data provenance for any "testing" conducted would be internal testing performed by Heeyoung Co., Ltd. in Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in the context of medical imaging interpretation by experts is not relevant for the regulatory clearance of a monitor. The ground truth for a monitor is its technical specifications and compliance with safety standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to schemes for expert review of medical cases, which is not relevant for a monitor.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed to assess the performance of diagnostic algorithms or systems, often comparing human readers with and without AI assistance. This type of study is not relevant for a monochrome LCD monitor.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a monitor, not an algorithm. Therefore, a standalone algorithm performance study was not conducted.
7. The Type of Ground Truth Used
For the monitor, the "ground truth" would be established by objective measurements against industry standards (e.g., DICOM Part 14, safety standards like EN 60601-1) and comparison to the technical specifications of the predicate device. This is based on physical measurements of display characteristics (brightness, contrast, resolution, etc.) and safety compliance.
8. The Sample Size for the Training Set
Not applicable. This device is a monitor, not an AI system that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set is relevant 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).