(56 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 K240310 for Shenzhen Beacon Display Technology Co., Ltd.'s LCD Monitors (C310S, G310S, C316S, G316S, C616W) but does not contain acceptance criteria or study details regarding AI/algorithm performance.
The submission focuses on establishing substantial equivalence to predicate devices through technical comparisons and bench testing of display characteristics. There is no mention of an AI/algorithm component requiring performance studies with human readers, ground truth establishment, or clinical evaluations.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving it meets them, as the provided text pertains to LCD monitors themselves, not an AI component.
The document does contain the following relevant information regarding the LCD monitors' performance:
The performance testing was done via bench tests and focused on the display characteristics of the monitors.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a pass/fail form with numerical targets. Instead, it states that the devices (C310S, G310S, C316S, G316S, C616W) were tested to verify "display characteristics equivalent to those of the predicate devices" and that they "meet DICOM Part 3.14 and other standards." The reported performance is implicitly shown through the comparison tables (Tables 1, 2, and 3) by comparing the proposed devices with their respective predicate devices.
Here's an example of some performance characteristics from the provided tables. For a full list, please refer to the "General Comparison" tables in the original document.
Example Table of Reported Device Performance (Partial - C310S/C316S Color LCD Monitors):
| Performance Characteristic | Acceptance Criteria (Implied: Equivalent to Predicate) | Reported Device Performance (C310S/C316S) | Predicate Device Performance (C32S+) |
|---|---|---|---|
| Native Resolution | 1536 x 2048 | 1536 x 2048 | 1536 x 2048 |
| Viewing Angle (H/V) | 178°/178° | 178°/178° | 178°/178° |
| Brightness (typical) | Equivalent to 1000 cd/m² (predicate) | 1100 cd/m² | 1000 cd/m² |
| Recommended brightness | Equivalent to 500 cd/m² (predicate) | 450 cd/m² | 500 cd/m² |
| Contrast Ratio (typical) | Equivalent to 1500:1 (predicate) | 2000:1 | 1500:1 |
| Conformance | Meet DICOM Part 3.14 and other standards | Met | Met |
Note: The "Explanation of Differences" column in the original tables addresses specific instances where the proposed device's performance differs numerically from the predicate but is considered substantially equivalent (e.g., "Different Panel" or "Different design scheme" for brightness/contrast differences, which are then justified by passing TG18 guideline tests).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the bench tests were performed on C310S, G310S, C316S, G316S, C616W," implying one or more units of each model. It does not mention a large sample size of images or cases, as this is a device for displaying images, not an image analysis algorithm.
- Data Provenance: Not applicable in the context of image data. The testing was conducted on the physical monitors themselves, measuring their optical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for evaluating display performance is based on established technical standards (e.g., DICOM Part 3.14, AAPM TG18 guideline) and objective measurements, not subjective expert interpretation of medical images on the device.
4. Adjudication method for the test set:
- Not applicable. Performance was assessed against objective technical specifications and standards using bench tests, not through human adjudication of diagnostic outcomes.
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. This is not an AI device. The submission does not describe an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used:
- Technical Standards and Objective Measurements: The "ground truth" for the display devices' performance is their conformance to established industry standards like DICOM Part 3.14 and the AAPM Task Group 18 (TG18) guideline for assessment of display performance. This includes measurements of spatial resolution (MTF), pixel defects, luminance characteristics (maximum, minimum, achievable, recommended), DICOM GSDF conformance, and color tracking.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires 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).