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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.

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.

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