(28 days)
C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.
3MP LCD Monitors C310S, G310S, C316S, G316S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer. 6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography.
This product has been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle.
G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle.
C310S and G310S have the same main board and design principle.
C316S and G316S have the same main board and design principle.
The provided text describes a 510(k) summary for several LCD medical displays (C310S, G310S, C316S, G316S, C616W) which are claimed to be substantially equivalent to a previously cleared device (K240310). The information does not detail an AI-powered device or a study involving human readers or comparative effectiveness for AI assistance. Instead, it focuses on the technical specifications and performance of the LCD monitors.
Therefore, the following information is extracted and parts that are not relevant to an AI/ML powered device or are not provided in the text are explicitly stated as such.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the "Description" column, indicating what was measured, and the "Test result" column, which uniformly states "PASS". This suggests that the measured performance met the predetermined criteria for each test.
| Measurements | Description | Test result | Acceptance Criteria (Implied) |
|---|---|---|---|
| 1. Spatial resolution | Measurement of spatial resolution expressed as modulation transfer function (MTF) | PASS | Meet predefined MTF standards |
| 2. Pixel defects | The maximum number allowed for each type of pixel defects/faults | PASS | Not exceed maximum allowed pixel defects/faults |
| 3. Artifacts | Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline | PASS | Absence of miscellaneous artifacts as per TG18 |
| 4. Temporal response | Measure the temporal response using the typical data provided by the panel manufacturer | PASS | Meet manufacturer's typical temporal response data |
| 5. Luminance (maximum, minimum, achievable, and recommended) | Meausure the maximum, minimum, achievable, and recommended luminance | PASS | Meet specified luminance ranges |
| 6. Conformance to a grayscale-to luminance function | Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline) | PASS | Conformance to DICOM GSDF as per TG18 |
| 7. Color tracking (primary colors and color gamut) | Measurement of Color tracking (primary colors and color gamut) | PASS | Meet specified color tracking and gamut standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are physical laboratory tests on the display embedded software using DBI Calibration Feedback System on the monitors, not a test on a test set of medical cases.
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)
This information is not provided as the device is an LCD monitor, not an AI / image analysis software requiring expert annotation for ground truth. The tests are technical performance evaluations of the display.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's not relevant for the type of device being described (an LCD monitor).
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study was not done as this device is an LCD monitor, which is a display hardware, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance tests of the LCD monitors is based on pre-determined technical criteria and industry standards (e.g., DICOM Part 3.14, AAPM Task Group 18 guideline, manufacturer's typical data). This is not a "ground truth" derived from medical diagnosis but from established engineering and display performance metrics.
8. The sample size for the training set
This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set and ground truth generation.
§ 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).