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R190/R191 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 does not support the display of mammography images for diagnosis.

Device Description

R190/R191 LCD Monitor is the display system with the resolution (1280*1024), high luminance (800cd/m2), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside. R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time.

The product is consisted of the following components:
-19inches, Mono-TFT LCD Panel

M150M/P38 motherboard/FR-4
R190/R191 LCD Monitor software
Power cable
Data Cable.

The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nanjing Jusha Display Technology Co., Ltd. R190/R191 LCD Monitor:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the R190/R191 LCD Monitor primarily focuses on demonstrating substantial equivalence to a predicate device (CHILIN MDM 1900-1NR LCD Monitor) through technical specifications and adherence to safety and EMC standards. As such, the "acceptance criteria" are largely defined by these comparative specifications and compliance with standards, rather than specific performance metrics directly measured against a predefined threshold in clinical studies for this particular device.

However, based on the provided text, we can infer some "acceptance criteria" and the reported performance as demonstrated through bench testing and comparison to the predicate.

Acceptance Criteria (Implied/Derived)	Reported Device Performance (R190/R191)	Reference
Display Performance
Resolution	1280x1024 (Matches the general capability of the predicate, though listed differently due to viewing directions)	Comparison Table
Screen Technology	19" Monochrome TFT LCD Panel (Same as predicate)	Comparison Table
Viewing Angle (H, V)	Horizontal 176°, Vertical 176° (Comparable to predicate's 170°, 170°)	Comparison Table
Contrast Ratio	1000:1 (Better than predicate's 800:1, deemed not to affect use)	Comparison Table
Response Time	16ms (Better than predicate's 18ms)	Comparison Table
Recommended Luminance	800cd/m² (Comparable to predicate's 1000cd/m², "difference is not large and does not affect the use" after curve correction)	Comparison Table
Pixel Pitch	0.2928x0.2928mm (Comparable to predicate's 0.294x0.294mm)	Comparison Table
Backlight	LED (Same as predicate)	Comparison Table
DICOM LUT	10-bit:1024 (Predicate 12-bit:4096. "Both devices use grayscale extension technology, and the final display effect is not much different, which does not affect the use of the product.")	Comparison Table
Luminance Calibration	Built-in calibration sensor provided (Same as predicate)	Comparison Table
Safety and Electrical
Electrical Safety	Complies with IEC 60601-1:2012	Bench Testing Summary
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014, EN 60601-1-2:2015	Bench Testing Summary
Functional/Performance
Angular dependency of luminance response	Bench tested and met performance standards	Bench Testing Summary
Luminance non-uniformity	Bench tested and met performance standards as specified in TGI18 guideline	Bench Testing Summary
Chromaticity non-uniformity	Bench tested and met performance standards as specified in TG18 guideline	Bench Testing Summary
Small-spot contrast ratio	Bench tested and met performance standards	Bench Testing Summary
Temporal response	Bench tested and met performance standards	Bench Testing Summary
Luminance stability	Bench tested and met performance standards	Bench Testing Summary

The study that "proves the device meets the acceptance criteria" is the non-clinical bench testing and the comparison to the predicate device as outlined. The FDA's issuance of the 510(k) clearance signifies their agreement that these tests and comparisons demonstrate substantial equivalence and thus meet the necessary criteria for safe and effective use.

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

Sample Size for the Test Set: Not applicable. This submission relies on bench testing of the device itself and comparison to a predicate device's established performance, rather than a test set of patient cases.
Data Provenance: Not applicable for a patient data test set. The data provenance for the technical specifications is from the manufacturer's own testing and specifications for both the proposed device and the predicate device (as reported in K061303).

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

Not applicable. No clinical test set with ground truth established by experts was used for this submission. The device is a display monitor, and its performance is evaluated based on technical specifications and adherence to standards, not its ability to interpret medical images.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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. An MRMC study was not done. This device is a medical display monitor and does not involve AI assistance for human readers.

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

No. This device is a display monitor and does not involve an algorithm with standalone performance.

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

Not applicable in the context of clinical images. The "ground truth" for this device's performance is based on engineering measurements and compliance with established technical international standards for medical displays (e.g., luminance, contrast, resolution, DICOM conformance, safety standards).

8. The Sample Size for the Training Set

Not applicable. The device is a medical display monitor and does not employ machine learning or AI that would require 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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