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JUSHA-C43 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

JUSHA-C43 LCD Monitoris the display system with the high resolution(2560 x 1600), high luminance(350cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096, 4 DICOM look up table inside, the product is consisted of the following components:

• 30inch, Color Active Matrix Liquid Crystal Display
• FR4-v0.4
• JUSHA-C43 LCD Monitor software
• Power Adapter
• Data Cable.

The LCD Monitoris designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:

1. IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005 + CORR. 1 (2006) +CORR. 2 (2007)
2. IEC 60601-1-2 Edition 3:2007, medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

The provided document describes the JUSHA-C43 LCD Monitor, a display system for medical imaging review and analysis. The submission focuses on demonstrating substantial equivalence to a predicate device (RADIFORCE RX440; K130070) through bench testing for display performance and adherence to electrical safety and electromagnetic compatibility (EMC) standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding pass/fail results or reported device performance against specific numerical targets. Instead, it lists the types of measurements performed in bench testing and states that the device "meets all performance standards" without providing the specific standards or numerical outcomes.

However, based on the Discussion of Differences in the comparison table, we can infer some implied performance expectations and how the JUSHA-C43 LCD Monitor performs relative to its predicate.

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

The document describes bench testing only. There is no mention of a test set involving medical images or patient data, nor is there any information about sample size for such a test set, country of origin, or whether it was retrospective or prospective. The testing was performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since there was no test set involving medical images or human interpretation, there were no experts used to establish 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 involving human interpretation was performed.

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 an LCD monitor, not an AI-powered diagnostic tool. No MRMC study was conducted, and the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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.)

The "ground truth" for the device's performance relies on engineering specifications and established international standards. For example, luminance and chromaticity non-uniformity were measured against TG18 guidelines, and electrical safety and EMC were evaluated against IEC 60601-1 and IEC 60601-1-2 standards.

8. The sample size for the training set

Not applicable. This device is a hardware display monitor; it does not involve machine learning or a training set.

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

Not applicable. No training set was used.

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