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JUSHA-C31 Medical Display 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 must not be used for digital mammography system.

JUSHA-C31 Medical Display is 53cm(20.8") color medical display with the high resolution(2048 x 1536), the product is consisted of the following components:

• 20.8 inch, Color Active Matrix TFT Liquid Crystal Display
• Motherboard HDVI-3M V1.0
• JUSHA-C31 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 60601-1Medical 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.

This submission describes a medical display device, not an AI or algorithm-driven device. Therefore, the information typically requested for AI-enabled devices (like acceptance criteria for algorithms, sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable here.

This 510(k) summary focuses on the substantial equivalence of the JUSHA-C31 Medical Display to a predicate device (RADIFORCE R31; K052344) based on non-clinical performance and safety testing.

Here's the relevant information that can be extracted from the provided text for a medical display device:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

The submission does not explicitly list quantitative acceptance criteria in a table format for performance metrics that would be typical for an AI device (e.g., sensitivity, specificity, AUC). Instead, it states compliance with recognized industry standards and performance attributes of the display itself.

However, based on the "Technology" and "Device Description" sections, we can infer some key performance characteristics:

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a hardware display device, not an algorithm being tested on a data set. The testing performed was for product safety and performance against technical specifications, not clinical data sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of clinical data, is not relevant for this type of device submission. The "testing" involved verifying the display's technical specifications and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance (with or without AI assistance) on clinical cases, which is not relevant for a display device.

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

No. This submission is for a display device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. For a display device, the "truth" is its adherence to technical specifications and safety standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Determination of Substantial Equivalence (from the document):

The device manufacturer asserts that "JUSHA-C31 Medical Display is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (450 cd/m² max) and 16.7M (8-bits data per R,G,B each)display color, 3 DICOM look up table inside."

The "Summary of Non-Clinical Tests" indicates that the display complies with voluntary standards (IEC 60601-1 and IEC 60601-1-2). Quality assurance measures included "Risk Analysis, Requirements Reviews, Design Reviews, Raw materials verification, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing (Verification), [and] Safety testing (Verification)."

The submission explicitly states: "The subject of this premarket submission, Medical Display, did not require clinical studies to support substantial equivalence."

Conclusion: The manufacturer concludes that the JUSHA-C31 Medical Display is "as safe, as effective, and performance is substantially equivalent to the predicate device(s) [RADIFORCE R31; K052344]." The FDA's letter (K131389) confirms this determination of substantial equivalence.

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