(169 days)
The 10MP Grayscale Flat Panel Display (GX1030) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
The 6GF6201-8CS## is a diagnostic 10MP gravscale flat panel display for viewing medical images. With the callbrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DV! graphic controller boards. The display is used in dual-head configuration.
The 10MP Grayscale Flat Panel Display uses a monochrome LCD panel employing in-plane switching (IPS) technology to allow wide viewing angles. It has a resolution of 4096 x 2560 pixels and is used in landscape mode. The display uses backlight sensor to automatically stabilize the set luminance levels of the CCFL backlight over time. It also sports an integrated front sensor for independent grayscale verification. The factory calibrated gamma response is stored in five lookup tables located in the display, allowing users to adapt the display to local lighting conditions and ensuring that the display function is DICOM compliant regardless of the display controller used.
The 10MP Grayscale Flat Panel Display may be offerent housing colors and with different logos. These cosmetic differences are reflected in the designators represented by the characters "$" and "#" included in the model trade name 6GF6201-8C$#, where $ represents a letter between A and Z, and # is a number between 0 and 9.
The 10MP Grayscale Flat Panel Display uses the same LCD panel from the same manufactorer as the predicate device and employs CCFL backlight technology. It is equipped with two integrated luminance sensors, one mounted rear center and a built in front sensor, as included with the Coronis Fusion 10MP.
The housing, stand, electronics and the integrated luminance sensors are not the same as those components used in the predicate devices. The overall design of the 6GF6201-8C$## was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and inhouse. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications.
While the predicate device is equipped with a proprietary high speed display controller, the 6GF6201-8CS## was designed to receive and display images from standard, commercial DVI display controllers.
The provided document is an Abbreviated 510(k) Summary for a medical display device, the EIZO 10MP Grayscale Flat Panel Display (GX1030). It is not a study report for an AI-powered device, but rather a regulatory submission for a display device.
Therefore, the document does not contain the information required to answer your request about acceptance criteria and a study proving an AI device meets them. Specifically:
- No AI device: The device described is a medical display, not an AI algorithm.
- No acceptance criteria for an AI algorithm: The document focuses on the display's technical characteristics and substantial equivalence to a predicate device, not on clinical performance metrics for an AI.
- No study proving AI device performance: The "tests" mentioned are related to safety, EMC, and display performance (e.g., luminance stability, gamma response), not on the diagnostic accuracy of an AI.
- No information on sample sizes (test/training sets), experts, adjudication methods, MRMC studies, or ground truth for an AI.
The document states:
- "EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications."
- "None of the tests revealed behaviors inconsistent with the expected performance of a 10MP grayscale flat panel display."
These statements refer to the display's technical performance validation, not a clinical study to evaluate an AI's diagnostic abilities.
§ 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).