(20 days)
The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+, G23S+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.
C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are 21.3-inch TFT LCD color/ grayscale monitors. They are specifically designed to provide the high definition image outputs for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1200 x 1600. The built-in brightness stabilization control circuits make sure the brightness of these monitors is stable in their life and the calibration is continuous, so the products meet the demand of high precision medical imaging. For C22SP+, G23SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the devices (2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+) are primarily established through performance testing against the AAPM Task Group 18 (TG18) guideline and comparison with predicate devices.
| Acceptance Criteria (Bench Tests per TG18 guideline and comparison to predicate) | Reported Device Performance | Comments |
|---|---|---|
| Conformance to DICOM GSDF | Verified | The test results showed conformance. |
| Luminance non-uniformity characteristics | Measured and found acceptable | The test results showed proper performance. |
| Chromaticity non-uniformity characteristics | Measured and found acceptable | The test results showed proper performance. |
| Chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance | Measured and found acceptable | The test results showed proper performance. |
| Presence or absence of miscellaneous artifacts on the display screen | Visually checked and found acceptable | The test results showed proper performance. |
| Spatial resolution (MTF) | Measured and found acceptable | The test results showed proper performance. |
| Maximum number allowed for each type of pixel defects/faults | Measured and found acceptable | The test results showed proper performance. |
| Equivalence to predicate devices in display characteristics | Demonstrated | The devices' display characteristics were found equivalent to predicate devices, with differences not affecting observer performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size for the test set. It mentions "bench tests were performed on C22S+, C22SP+, G22SP+, G22SP+, G23SP+" for multiple devices (six models in total). It implies one or more units of each model were tested.
The data provenance is not explicitly stated. However, since the submitter is Shenzhen Beacon Display Technology Co., Ltd. in China, it is highly likely that the testing was conducted in China or under their direct supervision. The study appears to be retrospective as it's a premarket notification for devices seeking substantial equivalence to already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The acceptance criteria relate to technical performance specifications of the monitors themselves (e.g., luminance, resolution), not diagnostic accuracy based on expert interpretation of medical images displayed on them. Therefore, there's no mention of experts establishing a ground truth for diagnostic accuracy in this context.
4. Adjudication Method for the Test Set
This information is not applicable as the described tests are technical performance evaluations of the monitors, not diagnostic studies requiring expert adjudication of image interpretations.
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 devices are medical monitors, not AI algorithms, so this type of study is not relevant to their regulatory clearance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. The devices are medical monitors, which display images for human interpretation, they are not algorithms.
7. The Type of Ground Truth Used
The "ground truth" used for this study is based on technical specifications and measurable performance according to established industry standards, specifically the AAPM Task Group 18 (TG18) guideline for assessing display performance for medical imaging systems. This involves quantifiable measurements of display characteristics rather than clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. As these are medical display monitors, there is no "training set" in the context of machine learning or AI algorithms. The monitors are hardware devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for these devices.
§ 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).