(109 days)
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.
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.
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).