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JUSHA-M23C LCD Monitor is intended to be used in displaying digital images by trained medical practitioners. JUSHA-M23C LCD Monitor does not support the display of mammography images for diagnosis.

JUSHA-M23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance (1000cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M23C has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:

• 21.3inches, Mono-TFT LCD Panel
• JUSHA- SMS_19inch motherboard/FR-4/REV:0.1
• JUSHA-M23C LCD Monitor software
• Power Adapter
• Data Cable.

The provided document describes the JUSHA-M23C LCD Monitor, which is a medical display device, and its substantial equivalence to a predicate device.

Here's the information requested based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the JUSHA-M23C LCD Monitor are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (RADIFORCE GX240; K120407) and compliance with relevant medical device standards. The "performance" in this context refers to the technical specifications of the device itself and its adherence to these standards.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of a dataset used for evaluating an AI algorithm. This device is a medical monitor, and its evaluation involved bench testing of the physical device, not an analysis of a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The product is a display monitor, not an AI algorithm that requires expert-established ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This device is a display monitor, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical display monitor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not describe a ground truth in the context of medical efficacy or diagnostic performance. For the technical performance of the monitor, the "ground truth" or reference points are the specifications of the predicate device and the requirements of the international standards (IEC 60601-1, IEC 60601-1-2, and TGI18 guideline).

8. The sample size for the training set

Not applicable. The product is a hardware device (LCD monitor), not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the JUSHA-M23C LCD Monitor meets its acceptance criteria is primarily an evaluation for substantial equivalence to a predicate device (RADIFORCE GX240) and compliance with established international standards for medical electrical equipment.

• Bench Testing: Various physical and performance characteristics of the monitor were measured, including angular dependency of luminance, luminance and chromaticity non-uniformity (against TG18 guideline), small-spot contrast ratio, temporal response, and luminance stability. The document states that the device "meets all performance standards" and complies with the TG18 guideline.
• Electrical Safety and EMC Testing: The device was tested for electrical safety against IEC 60601-1 and for electromagnetic compatibility against IEC 60601-1-2. The results indicate compliance with these standards.
• Comparison to Predicate: A direct comparison of technical specifications between the JUSHA-M23C and the predicate device (RADIFORCE GX240) was performed (as shown in the table in the 510(k) summary and Attachment 1). The conclusion is that the JUSHA-M23C employs maximum resolution values same as the predicate and is "substantially equivalent."
• Clinical Studies: The document explicitly states that the device "did not require clinical studies to support substantial equivalence." This is common for devices that are deemed to have similar technological characteristics and intended use as an already approved predicate.

In essence, the "study" for this device involved a thorough technical comparison, functional bench testing, and adherence to established safety and performance standards to demonstrate that it operates safely and effectively as a medical display monitor, similar to the predicate device.

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