The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

Device Description

The RadiForce GX530 is a 5MP monochrome LCD monitor for viewing medical images including those of digital mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles. The matrix size (or resolution) of the panel is 2560 x 2048 pixel pitch is 0.165 mm, both of which are the same as those of displays approved so far for digital mammography including the predicate device, RadiForce GS10. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF) and a specific luminance range, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX530 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX530.

AI/ML Overview

The provided document is a 510(k) summary for the EIZO RadiForce GX530 5MP Monochrome LCD Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a study evaluating the performance of AI. Therefore, it does not contain information typically found in a study that proves a device meets acceptance criteria related to AI performance.

The document discusses the technical characteristics and intended use of the monitor and compares it to a predicate device (RadiForce GS510, K062054) to establish substantial equivalence.

Here's an breakdown of the information provided, framed against your request for acceptance criteria and study details, highlighting what is and isn't present:

Context: This document is about a medical display monitor, not an AI algorithm. Therefore, many of your requested items regarding AI performance, training sets, ground truth methodology, and expert adjudication are not applicable or present in this filing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for a study in the way one would for an AI algorithm. Instead, it focuses on demonstrating that the RadiForce GX530 meets performance requirements by being substantially equivalent to its predicate device.

The performance characteristics discussed are primarily related to monitor specifications and functionality:

Feature/Characteristic	Acceptance Criteria (Implicitly, by showing equivalence to predicate)	Reported Device Performance (RadiForce GX530)
Matrix Size (Resolution)	Must be equivalent to predicate to display digital mammography (2560 x 2048 pixels)	2560 x 2048 pixels (Same as predicate)
Pixel Pitch	Must be equivalent to predicate (0.165 mm)	0.165 mm (Same as predicate)
Active Area Size	Must be equivalent to predicate (337.9 mm x 422.4 mm)	337.9 mm x 422.4 mm (Same as predicate)
Tone Curve Compliance	Must display images in accordance with DICOM GSDF by default	DICOM GSDF compliant, utilizing factory calibrated display modes stored in lookup tables
Input Video Signal	Support for DVI (predicate)	Supports DVI and DisplayPort (new, but digitally equivalent)
Quality Control Software	Use of appropriate QC software (RadiCS)	Same QC software (RadiCS/RadiCS LE) used as predicate, included in submission.
Backlight Stabilization	Implementation of Backlight Sensor (BS)	Same implementation of Backlight Sensor (BS)
Automatic Grayscale Calibration	Functionality for calibration, with or without human intervention	Built-in Front Sensor (IFS) enables automatic grayscale calibration, reducing human intervention. (Precision data for calibration with external vs IFS sensor provided as validation data, though specific results are not detailed here).
Safety and EMC Standards	Compliance with internationally recognized standards	Overall design validated in accordance with internationally recognized safety and EMC standards by independent and in-house facilities.
System and Performance Tests	No behaviors inconsistent with expected performance	Performed a range of system and performance tests; none revealed inconsistencies.

2. Sample size used for the test set and the data provenance

Not Applicable. This document describes a medical monitor, not an AI device evaluated with a test set of data. The "test set" in this context refers to the monitor's functionality and compliance, not diagnostic image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth for diagnostic images is not a concept applied to the evaluation of a display monitor in this context. The "truth" here relates to the monitor's adherence to technical specifications and ability to display images correctly.

4. Adjudication method for the test set

Not Applicable. No expert adjudication of diagnostic interpretations is described, as this is a hardware device submission.

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, so MRMC studies involving AI assistance are not relevant or present in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. No algorithm performance is being evaluated.

7. The type of ground truth used

Technical Specifications and Regulatory Standards: The "ground truth" for this device's evaluation is its adherence to technical specifications, industry standards (like DICOM GSDF), and safety/EMC regulations. The basis for comparison is the predicate device's established performance. The document states "precision data of the calibration with an external sensor and with the IFS is provided as one of the validation data," indicating measurements against known photometric standards.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI algorithm.

9. How the ground truth for the training set was established

Not Applicable. No training set for an AI algorithm exists for this device.

Summary

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K112354

NOV 3 0 2011

EIZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan

U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Name	Hiroaki Hashimoto
Department	Medical Device Standards
Telephone	+81 (76) 274-2468
Fax	+81 (76) 274-2484
E-Mail	hiro@nanao.co.jp
Date	August 11th, 2011

Traditional 510(k) Summary (in accordance with 21 CFR 807.92)

Date of Summary 1. August 11th, 2011
1. Company EIZO NANAO CORPORATION 153 Shimokashiwano. Hakusan Ishikawa 924-8566 Japan
1. Authorized Contact Person Hiroaki Hashimoto

4. Device Information

. Trade Name/Model: RadiForce GX530 5MP Monochrome LCD Monitor . Common Name: Classification Name: · System, Image Processing, Radiological .
21 CFR 892.2050, Product Code LLZ Classification Number: .

5. Predicate Device

5MP Monochrome LCD Monitor, RadiForce GS510 (K062054)

6. Device Description

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX530 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX530.

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7. Intended Use

The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

8. Technological Characteristics

RadiForce GX530 can be said to have at least the same display performance as those of the predicate device by default due to the following reasons:

· The matrix sizes (2048 x 2560) and the active area sizes (337.9 mm x 422.4 mm) of the LCD panels used by . the both devices are the same though they are from different manufacturers.
The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated . display mode stored in one of the lookup tables inside of them.
. As for input video signal, in addition to the Digital Visual Interface (DVI) also supported by the predicate device, RadiForce GX530 supports DisplayPort, another type of digital video interface based on an industrial standard. As far as the both the DVI and the DisplayPort are digital, their differences do not affect the image quality.

As for the maintenance, the same OC software is used for the both devices and the implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same.

As for built-in sensors, in addition to BS common to the both devices, GX530 has three kinds of sensors. However, only the Built-in Front Sensor (IFS) has something to do with the maintenance or the calibration; the Presence Sensor detects the absence of the user to trigger the power saving mode of the Ambient Light Sensor is used to measure the ambient light by Ix. The IFS enables automatic grayscale callbration by measuring the luminance at the screen surface. Without IFS, the grayscale calibration process requires human intervention and the use of an external sensor. The precision data of the callbration with an external sensor and with the IFS is provided as one of the validation data.

The overall design of the RadiForce GX530 was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones. Besides, EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce GX530 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

9. Conclusion

Section-05

5MP Monochrome LCD Monitor, RadiForce GX530 is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The primary components are the same and those that are different have been independently validated. Any differences between the devices do not affect safety or effectiveness.

The 510(k) Premarket Notification for the RadiForce GX530 contains sufficient information and data to enable FDA -CDRH to determine substantial equivalence to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Hiroaki Hashimoto Manager EIZO NANAO CORPORATION 153 Shimokashiwano 924-8566 HAKUSAN ISHIKAWA JAPAN

NOV 3 0 2011

Re: K112354

Trade/Device Name: 5 MP Monochrome LCD Monitor, RadiForce GX530 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 11, 2011 Received: August 16, 2011

Dear Mr. Hashimoto:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Jrug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

5 MP Monochrome LCD Monitor, RadiForce GX530

Indications For Use:

The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Ding

510K

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Regulation Number and Section

§ 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).