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C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

C350G LCD Monitor is the display system with the high resolution (2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C350G has ambient brightness adapting, real-time DICOM automatic calibration 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:

• 21.3" Color TFT LCD Panel
• DMX3304AR2/main board
• C350G LCD Monitor software
• a graphic card
• a graphic card driver CD
• a CGA software CD
• an AC power cord
• an external power supply
• a DVI cable
• a DP cable
• a USB cable

M550G LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, M550G has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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:

• 21.3" Mono-TFT LCD Panel
• DMX3304AR2/main board
• M550G LCD Monitor software
• a graphic card
• a graphic card driver CD
• an AC power cord
• an external power supply
• a DVI cable
• a DP cable
• a USB cable

The provided text is a 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. C350/C350G LCD Monitor and M550/M550G LCD Monitor. This document states that no clinical studies were required or conducted to support substantial equivalence for these medical display monitors. Therefore, there is no information available in the provided text regarding acceptance criteria related to a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, or clinical performance compared to human readers.

The performance data described are related to bench testing and electrical safety/EMC, which are non-clinical evaluations of the device's technical specifications.

Here's an analysis of what is provided:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of specifications between the proposed devices (C350G and M550G LCD Monitors) and their respective predicate devices (C270G and BARCO MDMG-5221 LCD Monitors). While these are technical specifications, they implicitly represent the performance and quality standards the proposed devices must meet or exceed to be considered substantially equivalent. There isn't a formal "acceptance criteria" table in the sense of a clinical study, but rather a comparison of technical attributes.

Implicit Acceptance Criteria (Technical Specifications) and Reported Device Performance:

• For C350G LCD Monitor (compared to predicate C270G LCD Monitor):

• For M550G LCD Monitor (compared to predicate BARCO MDMG-5221 LCD Monitor):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. The submission states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." Therefore, no clinical test set was used. The "test set" in this context refers to the specific physical units of the monitors that underwent bench testing and electrical safety/EMC testing.

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, no ground truth established by experts was required for the purpose of this 510(k) submission.

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

• Not applicable. No clinical test set.

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 done. This device is a display monitor, not an AI-powered diagnostic tool. The submission explicitly states "The software doesn't include any functions of image manipulation."

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

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

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

• Not applicable. No clinical ground truth was established or used for the purpose of this submission. The "ground truth" for the bench testing would be the physical and electrical specifications of the monitors, measured against industry standards (e.g., TG18 guideline for display characteristics) and engineering requirements.

8. The sample size for the training set

• Not applicable. No machine learning model or "training set" in that sense was used or discussed in this 510(k) summary.

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

• Not applicable. As above, no training set for an algorithm was used.

Summary of Study:

The "study" cited in this 510(k) summary to prove the device meets acceptance criteria consists of non-clinical bench testing and electrical safety and electromagnetic compatibility (EMC) testing. This is typical for medical devices that are primarily hardware components and do not have algorithmic diagnostic or therapeutic functions.

• Bench Testing: Evaluated display characteristics such as luminance response, luminance non-uniformity, chromaticity non-uniformity, small-spot contrast ratio, temporal response, and luminance stability. These tests were conducted against general performance standards and guidelines (e.g., TGI18 guideline).
• Electrical safety and EMC testing: The devices demonstrated compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards.

The conclusion is that the proposed monitors are "substantially equivalent" to predicate devices based on these non-clinical tests, implying they are as safe and effective and perform as intended.

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