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JUSHA-MS2C Medical Display is intended to be used by trained physicians in various kinds of medical including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

JUSHA-M52C Medical Display is the display system with the high resolution(2048 x 2560), high luminance(700 cd/m²), and 256 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table inside, the product is consisted of the following components:

• 21.3 inch, mono-TFT Liquid Crystal Display
• Motherboard HDVI-3M V1.0
• JUSHA-M52C Medical Display software
• Power Adapter
• Data Cable.
  The Medical Display is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:

1. IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995
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 text describes a 510(k) Premarket Notification Submission for the JUSHA-M52C Medical Display. This document focuses on demonstrating substantial equivalence to a predicate device based on technical performance and compliance with relevant standards, rather than clinical efficacy through studies with human readers or AI algorithms. As such, many of the requested criteria are not applicable or explicitly mentioned in this type of submission.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of a clinical or performance study with quantified thresholds. Instead, it demonstrates compliance with recognized standards and technical specifications that are implicitly accepted for a medical display device. The device's performance is reported in terms of its technical specifications.

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

Not applicable. This submission is for a medical display, which is a hardware device. The "test set" in this context refers to testing of the hardware's compliance with technical specifications and safety standards, not a clinical dataset for an AI algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. There is no "ground truth" established by medical experts for a test set in the context of a medical display's technical performance and safety testing. The evaluation is based on engineering and regulatory standards.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication in this submission.

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 medical display, not an AI-powered diagnostic tool. No MRMC study was performed or required.

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

Not applicable. This device is a medical display, not a standalone algorithm.

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

Not applicable. The "ground truth" for this device's performance relates to its adherence to technical specifications and safety standards, which are objectively measurable and defined by industry and regulatory bodies (e.g., luminance, resolution, electrical safety).

8. The sample size for the training set

Not applicable. This device is a medical display, not a machine learning model. There is no "training set."

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

Not applicable. There is no "training set" or associated ground truth for this type of device.

Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria (implicitly, substantial equivalence) is the non-clinical testing summarized in the submission. The submission states:

• "Summary of Non-Clinical Tests: The Medical Display complies with voluntary standards as following: 1 IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995 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."
• It also states, "JUSHA-M52C is substantially equivalent to RadiForce G51. M52C employs the maximum resolution values same as that of RadiForce G51. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1." The Attachment 1, though not provided in the excerpt, would be the direct comparison to the predicate.
• Quality assurance measures applied to the development include: Risk Analysis, Requirements Reviews, Design Reviews, Raw materials verification, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), and Safety testing (Verification).

Conclusion:

This 510(k) submission demonstrates substantial equivalence for a medical display by documenting that its technical specifications (resolution, luminance, shades of gray, DICOM LUT) are comparable to a legally marketed predicate device (RADIFORCE G51) and that it complies with relevant safety and EMC standards (IEC 60601-1 and IEC 60601-1-2). Clinical studies, AI performance metrics, or "ground truth" from medical expert consensus are not typically part of the evidence for a medical display's substantial equivalence.

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