The RadiForce RX430 is intended to be used in displaying and viewing digital images of X-ray or MRI etc. by trained medical practitioners. The RadiForce RX430 does not support the display of mammography images for diagnosis.

Device Description

The RadiForce RX430 is a 4MP Color LCD monitor for viewing medical images. The matrix size of the color panel, 2560 x 1600 pixels with a pixel pitch of 0.2505 mm corresponds to two 2MP monitors in portrait mode (1200 x 1600 x 2 with a pixel pitch of e.g. 0.270 mm) and provides dual-head configuration without the obtrusive bezel in the center. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, 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 RX430 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 RX430.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the EIZO RadiForce RX430, a 4MP Color LCD monitor for displaying medical images. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific performance metrics and acceptance criteria as would be found in a clinical validation study for an AI-powered diagnostic device.

Therefore, many of the requested elements (e.g., specific acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications for ground truth, MRMC study details, standalone performance) are not applicable or not explicitly stated in this type of submission for a medical display monitor.

Here's an attempt to answer the questions based on the available information, highlighting where information is not present in the document.

1. A table of acceptance criteria and the reported device performance

For a medical display monitor, acceptance criteria typically revolve around display characteristics meeting established standards (e.g., DICOM GSDF, luminance, contrast, resolution, viewing angle). The document references these implicitly by comparing the new device to a predicate and stating adherence to standards.

Acceptance Criteria (Implied)	Reported Device Performance
Display Performance Equivalent to Predicate Device	"RadiForce RX430 can be said to have at least the same display performance as those of the predicate device by default..."
Matrix Size / Resolution	RadiForce RX430: 4MP (2560 x 1600 pixels, pixel pitch 0.2505 mm). This "corresponds to two 2MP monitors in portrait mode". The LCD panels used by both the RX430 and predicate device have the same matrix sizes (4096 x 2560) and active area sizes (641.3 mm x 400.8 mm). (Note: There's a discrepancy in stated matrix sizes for RX430 between "4MP (2560 x 1600)" and "4096 x 2560" for the LCD panel. The 4MP (2560x1600) is the effective display resolution for user, while 4096x2560 represents the physical panel resolution. In context, 2560x1600 = 4,096,000 pixels which is roughly 4MP. The 4096x2560 mentioned later is higher resolution, implying the monitor might be downscaling or offering a larger internal resolution than the marketed 4MP. However, for a 510k, comparison to the predicate's panel is key. It is likely referring to manufacturer's panel internal resolution which may be truncated or downscaled to the effective display resolution. Relying on the stated 4MP and direct comparison to predicate for display functionality.)
Viewing Angle	RX430 employs In-Plane Switching (IPS) technology, "well-known for its wider viewing angle than other technologies like Twisted Nematic (TN) or Vertical Alignment (VA) employed by the panel of the predicate device." (Implies better or equivalent performance).
Luminance Range	"The maximum luminance and the recommended or default luminance of the former [RX430] is much higher" than the predicate device. (Implies better performance).
DICOM GSDF Compliance	"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."
Input Video Signal Compatibility	RX430 supports Digital Visual Interface (DVI) (like predicate) and DisplayPort. "As far as the both the DVI and the DisplayPort are digital, their differences do not affect the image quality."
Image Quality / Consistency	"factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used." "The implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same." "The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface." "The precision data of the calibration with external sensors and with the IFS is provided as one of the validation data." "None of the tests revealed behaviors inconsistent with the expected performance."
Safety and EMC Standards Compliance	"The overall design of the RadiForce RX430 was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones."
No compromise on Safety or Effectiveness compared to predicate	"Any differences between the devices do not affect safety or effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as this is a submission for a display monitor, not an AI or image analysis device that would typically involve patient data test sets. The "validation data" mentioned for IFS precision would refer to technical measurements, not patient studies.

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)

This information is not provided and is not applicable for a display monitor's 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable for a display monitor's 510(k) 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

A MRMC study was not done as this is a medical display monitor, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a display monitor, not an algorithm. Its performance is evaluated based on its display characteristics and compliance with technical standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of demonstrating substantial equivalence for a medical monitor, the "ground truth" relates to compliance with technical specifications and standards (e.g., DICOM GSDF, luminance, resolution, safety, EMC). This is established through instrument-based measurements, engineering tests, and adherence to international standards, rather than clinical ground truth like pathology or expert consensus on clinical cases. The document mentions "precision data of the calibration with external sensors and with the IFS" as validation data, which would be an example of instrument-based ground truth.

8. The sample size for the training set

This information is not applicable as the device is a display monitor, not a machine learning model that requires training data.

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

This information is not applicable for the reasons stated above.

Summary

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K 112466

OCT 2 7 2011

E1ZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa

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 22nd, 2011

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

1. Date of Summary August 22nd, 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 RX430
4MP Color LCD Monitor ● Common Name:
. Classification Name: System, Image Processing, Radiological
Classification Number: 21 CFR 892.2050, Product Code LLZ .

5. Predicate Device

Color LCD Monitor, FlexScan MX300W (K073340) .

6. Device Description

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RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX430 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 RX430.

7. Intended Use

8. Technological Characteristics

RadiForce RX430 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 (4096 x 2560) and the active area sizes (641.3 mm x 400.8 mm) of a. the LCD panels used by the both devices are the same though they are from different manufacturers.
b. The panel of RadiForce RX430 employs In-Plane Switching (IPS) technology which is well-known for its wider viewing angle than other technologies like Twisted Nematic (TN) or Vertical Alignment (VA) employed by the panel of the predicate device.
c. Though the RadiForce RX430 and the predicate device employ CCFL backlight technology, the maximum luminance and the recommended or default luminance of the former is much higher.
d. 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.
e. As for input video signal, in addition to the Digital Visual Interface (DVI) also supported by the predicate device, RadiForce RX430 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, RX430 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 monitor and the Ambient Light Sensor is used to measure the ambient light by lx. The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface. Without IFS, the grayscale calibration process requires human intervention and

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the use of an external sensor. The precision data of the calibration with external sensors and with the IFS is provided as one of the validation data.

The overall design of the RadiForce RX430 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 RX430 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

9. Conclusion

The 4MP color LCD monitor. RadiForce RX430 is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of 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 RX430 contains sufficient information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

OCT 2 7 2011

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 - Medical System Standards 153 Shimokashiwano Hakusan, Ishikawa, 924-8566 JAPAN

Re: K112466

Trade/Device Name: 4MP Color LCD Monitor, RadForce RX430 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: August 26, 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, Drug, 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, insting 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 2007 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish frinther 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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Enclosure

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. S. 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

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Indications for Use

510(k) Number (if known):

Device Name:

4MP Color LCD Monitor, RadiForce RX430

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Mary Slatil
(Division Sign Off)

Division of Radiological Office of In Vitro Diagnostic Device Evaluation

510K K112466

Indications for Use Statement_RX430.doc: Page 1 of 1

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).