(114 days)
The 5MP Grayscale Flat Panel Display is intended to be used in displaying and viewing digital images, including digital mammography, for review, analysis and diagnosis by trained medical practitioners.
The 6GF6201-5C$2# is a diagnostic 5MP grayscale flat panel display for viewing medical images. With the calibrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DVI graphic controller boards. The display can be used in single-head or multi-head configurations.
This document is a 510(k) summary for the EIZO 6GF6201-5C$2# 5MP Grayscale Flat Panel Display. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria related to its performance in medical image interpretation.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices (Coronis 5MP (K042221) and Nio 5MP-M-21" (K062131)) based on technical characteristics, application, and intended use. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence for a medical device display, rather than clinical performance metrics for an AI algorithm.
Therefore, I cannot provide a "table of acceptance criteria and the reported device performance" as typically expected for an AI algorithm, nor can I answer many of the specific questions about clinical studies, ground truth, or expert involvement because this document pertains to display hardware, not an AI diagnostic tool.
However, I can extract information relevant to the regulatory approval process if that's what you're interested in.
Based on the provided text, the device is a medical display, not an AI algorithm. Therefore, many of your questions related to AI algorithm performance studies, ground truth, and expert adjudication are not applicable.
Here's an analysis of the available information in the context of a medical display device approval:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of specific quantitative acceptance criteria for image interpretation performance (like sensitivity, specificity, or accuracy) because the device is a display, not a diagnostic algorithm. The acceptance criteria for a display involve technical specifications and compliance with standards.
The document states:
- "EIZO GmbH performed a range of system and performance tests to ensure that the 5MP Grayscale Flat Panel Display performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a 5MP grayscale flat panel display."
- "The 5MP Grayscale Flat Panel Display is substantially equivalent to the predicate devices with respect to technical characteristics, application and intended use."
Technical Characteristics and Performance (as reported for the device):
| Characteristic | Reported Device Performance/Feature |
|---|---|
| Common Name | Display, 5MP Grayscale Flat Panel Display |
| Classification Name | System, Image Processing |
| Classification Number | 21 CFR 892.2050 (Picture archiving and communications system) |
| Panel Type | Monochrome LCD panel employing in-plane switching (IPS) technology |
| Resolution | 2048x2560 pixels |
| Viewing Angles | Wide |
| Modes | Portrait and Landscape |
| Luminance Stability | Integrated luminance sensor (ISS) to automatically stabilize set luminance levels of CCFL backlight. |
| Grayscale Verification | Front luminance sensor (ICS) for independent grayscale verification. |
| Gamma Response | Factory calibrated, stored in five internal lookup tables, adaptable to local lighting conditions, DICOM compliant. |
| Display Controller Compatibility | Designed to receive and display images from standard, commercial DVI display controllers (unlike predicate devices which use proprietary controllers). |
| Software | Can be used with "SMfit Total Care software package" for lookup table selection, test patterns, calibration, and peripheral information. |
| Safety & EMC | Validated in accordance with internationally recognized safety and EMC standards by independent testing facilities. |
| Overall Performance | "Performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a 5MP grayscale flat panel display." |
| Equivalence | "Substantially equivalent to the predicate devices with respect to technical characteristics, application and intended use." Differences (housing, stand, electronics, integrated luminance sensors) were validated and "do not affect safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a display device. The "tests" mentioned were likely engineering and performance validation tests of the hardware, not clinical studies on image sets.
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):
Not applicable. No ground truth for image interpretation was established as this is a display device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical adjudication was performed as this is a display device.
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:
Not applicable. This is a display device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a display device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for image interpretation was used. The "ground truth" for a display would refer to calibration standards and objective measurements of display characteristics (luminance, color accuracy, resolution, etc.).
8. The sample size for the training set:
Not applicable. This is a display device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a display device, not an AI algorithm.
§ 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).