(54 days)
CP620G/CP620 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
CP620G/CP620 LCD Monitor is the display system with the high resolution (30002000), high luminance (500 cd/m2), and 4398 billion colors, built-in DICOM standard LUT. Monitor is portable and light, the 750g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.(There is no difference between CP620G and CP620 except for labeling as they are marketed in different areas. CP620G is global sales, CP620 is domestic sales .It does not affect their safety or effectiveness in any terms. ) The product is consisted of the following components: - 13.5" Color-TFT LCD Panel - DMS3400AR0/6 layers/214150mm/1.0mm/REV:1.0 - CP620G LCD Monitor software - Power Adapter - Data Cable. In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the CP620G/CP620 LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. the software doesn't include any functions of image manipulation. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
The information provided describes the Nanjing Jusha Display Technology Co., Ltd. CP620G LCD Monitor / CP620 LCD Monitor. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of measurable thresholds for diagnostic accuracy (e.g., sensitivity, specificity for an AI algorithm). Instead, the performance data presented focuses on the technical specifications of the display and compliance with established electrical safety and electromagnetic compatibility (EMC) standards. The "predicate device" is used as the benchmark for substantial equivalence.
| Attribute | Acceptance Criteria (Predicate Device K200472) | Reported Device Performance (CP620G / CP620 LCD Monitor - K230643) |
|---|---|---|
| Screen Technology | 13.5" Color TFT LCD Panel | 13.5" Color TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 170°, Vertical 170° |
| Resolution | 3000x2000 | 3000x2000 |
| Display Area | 285.3(V)x190.2(H)mm | 285.3(V)x190.2(H)mm |
| Contrast Ratio | 1800:1 | 1800:1 |
| Scanning frequency (H; V) | 94.94~123.84kHz; 60Hz | 94.94~123.84kHz; 60Hz |
| Recommended Luminance | 300cd/m2 | 500cd/m2 |
| Pixel Pitch | 0.0951x0.0951mm | 0.0951x0.0951mm |
| Backlight | LED | LED |
| Display Colors | 14-bit, 4398 billion colors | 14-bit, 4398 billion colors |
| Luminance Calibration | General calibration sensor | General calibration sensor |
| Video Signal Input | Type-C x1, Mini DP x1 | Type-C x2, HDMI x1 |
| Display Controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Power Consumption/Save Mode | 15W / N/A | 20W / NA |
| Applicable Standards | IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14; IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015 | IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14; IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015 |
Discussion of Differences:
- Recommended Luminance: The proposed device has a higher recommended luminance (500cd/m2) than the predicate (300cd/m2), which is considered an improvement ("CP620G is better than CP610").
- Video Signal Input: The proposed device has different input ports (Type-C x2, HDMI x1 vs. Type-C x1, Mini DP x1). This difference is stated to "only shows that they have different input, has nothing to do with the display function."
- Power Consumption/Save Mode: The proposed device has a higher power consumption (20W vs. 15W). This is attributed to "components used in the LCD Monitor" and is stated to have "nothing to do with the display function."
- Dimensions w/o stand: Slight differences are noted (312.3mmx220mmx11.5mm vs. 323mmx225x11.5mm), explained as "Different housing design due to the different glass size."
- New Features: The proposed device includes new features: Bidirectional power supply function, dual-screen display function, gravity sensing function, adaptive environment brightness function, and screen touch function. These are all described as making the product "more convenient" and "has nothing to do with the display function" (except for dual-screen display, which allows two independent 3MP windows side-by-side).
2. Sample size used for the test set and the data provenance
The document describes bench testing for the CP620/CP620G. There is no mention of a "test set" in the context of clinical images or patient data. The testing pertains to the physical and electrical performance of the display monitor itself. Therefore, concepts like sample size and data provenance (country, retrospective/prospective) are not applicable in the way they would be for an AI diagnostic algorithm. The tests conducted include:
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display screen
- Measurement of the chromaticity non-uniformity characteristics of the display screen
- Measurement of small-spot contrast ratio
- Measurement of temporal response
- Performance data on luminance stability
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is an LCD monitor for displaying medical images, not an AI algorithm that provides diagnostic interpretations requiring expert ground truth setting for a dataset. The "ground truth" for this device relates to its physical performance characteristics meeting technical specifications, which are verified through various physical and electrical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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 MRMC comparative effectiveness study was done. This device is an LCD monitor, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance acceptance is based on:
- Technical Specifications: Measured physical and electrical properties of the display (luminance, contrast, resolution, viewing angle, color, etc.) matching or exceeding the predicate device's specifications.
- Compliance with Standards: Adherence to recognized medical device safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
8. The sample size for the training set
This information is not applicable. The device is a monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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).