RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.

Device Description

RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 displays high-definition medical imaging.

AI/ML Overview

The provided text describes a 510(k) summary for the EIZO NANAO CORPORATION's Color LCD Monitor, RadiForce RX320. This document primarily focuses on establishing substantial equivalence to a predicate device (RadiForce R31 and R31-C) rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical trial for an AI/CAD product.

The device is a medical display monitor, and its "performance" is evaluated based on its technical specifications compared to the predicate device. The acceptance criteria essentially revolve around demonstrating that the new device meets or exceeds the specifications of the predicate device, or that any differences do not raise new questions of safety and effectiveness.

Here's a breakdown based on your request, with the understanding that the nature of the device (a monitor) means "performance" and "ground truth" are interpreted differently than for an AI diagnostic algorithm:

A table of acceptance criteria and the reported device performance:

Feature/Acceptance Criteria (Predicate R31/R31-C)	Reported Device Performance (RX320)	Meets/Exceeds
Brightness: 400 cd/m²	900 cd/m²	Exceeds
Contrast Ratio: 400:1 (typical)	1000:1 (typical)	Exceeds
Response Time: 50 ms (typical)	20 ms (typical)	Exceeds
Panel Size: 53 cm (20.8") TFT Color LCD	54cm (21.2") TFT Color LCD	Exceeds (slightly larger)
Pixel Pitch: 0.207 x 0.207mm	0.21075 x 0.21075 mm	Similar (slightly larger pixel)
Scanning Frequency (H, V): 31-127kHz, 59-61Hz	31-127kHz, 29-61Hz	Similar
Native Resolutions: 2048 x 1536 (portrait)	Same as R31 and R31-C	Meets
Display Colors: 10-bit: 1.06 billion (max)	Same as R31 and R31-C	Meets
Viewing Angles: H: 170°, V: 170°	Same as R31 and R31-C	Meets
Luminance Calibration: Software (Optional), Photo-sensor (Optional)	Software (Optional), Photo-sensor (Optional), Digital Uniformity Equalizer (DUE)	Exceeds (added DUE)
Intended Use: Display and view digital images for diagnosis of X-ray or MRI etc. (excluding mammography)	Same as predicate	Meets

Note: The acceptance criteria here are implicitly defined by the specifications of the predicate device. The new device demonstrates "substantial equivalence" by meeting or improving upon these key specifications.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This is not applicable to a medical display monitor's 510(k) submission. The "test set" would be the device itself being tested for its physical and electrical characteristics, not a set of medical images. The document does not describe a study involving medical image data.
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 as no "ground truth" for medical image interpretation is established for this device submission. The device is a display, not a diagnostic algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 device is a display monitor, not an AI/CAD system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (monitor), not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, contrast, etc.) as listed in the table, which are inherently "algorithm-only" in the sense that they are physical measurements of the device's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for a monitor is its adherence to technical manufacturing specifications and industry standards for display performance (e.g., luminance, contrast, resolution), measured using calibrated equipment. This document does not detail the specific test methods or "ground truth" sources used to verify these specifications, but it is implied to be standard engineering and quality control procedures.
The sample size for the training set:
- Not applicable. This device does not involve machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable. No training set is involved for this device.

Summary

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16090045

510(k) Summarv as required by 807.92

1. Company Identification

EIZO NANAO CORPORATION 153 Shimokashiwano-cho. Hakusan-shi. Ishikawa-ken. 924-8566. Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484

JAN 2 8 2009

1. Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Product Safety

Date of Submission January 6, 2009
Device Trade name Color LCD Monitor, RadiForce RX320

5. Common/Usual Name

Image display system, medical image workstation, image monitor/display, and others

6. Classification Number

Medical displays classified in Class II per 21 CFR 892.2050.

7. Predicate Device

Manufacturer : EIZO NANAO CORPORATION Device Name : Color LCD Monitor Model Name : RadiForce R31 and R31-C 510(k) No. : K052344

8. Description of Device

RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 displays high-definition medical imaging.

9. Intended Use

10. Technological Characteristics

RadiForce RX320 is substantially equivalent to R31 and R31-C (K052344). Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non-uniformity. RX320 improved the brightness and contrast of the LCD module, and modified the calibration software. The brightness improved in 900 cd/m2 from 400 cd/m2. The contrast improved by it.

Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.

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Appendix 1: Comparison Table with Predicate Device

Items	R31	R31-C	RX320
510(k) Number	K052344		Not Provided
Panel Protector	Not provided	Provided	Optional
Panel Size andType	53 cm (20.8") TFT Color LCD panel		54cm (21.2") TFT ColorLCD panel
Pixel Pitch	0.207 x 0.207mm		0.21075 x 0.21075 mm
Cabinet Color	Black		Same as R31 and R31-C
Display Colors	10-bit: 1.06 billion (maximum)8-bit: 16.77 million from a palette of 1.06billion		Same as R31 and R31-C
Viewing Angles	H: 170°, V: 170°		Same as R31 and R31-C
ScanningFrequency(H, V)	31-127kHz, 59-61Hz(VGA Text: 69-71Hz,QXGA: 36-61Hz)Frame synchronous mode: 59-61Hz		31-127kHz, 29-61Hz(VGA Text: 69-71Hz)Frame synchronous mode:59-61Hz
Native Resolutions	2048 x 1536 (portrait)/1536 x 2048 (landscape)		Same as R31 and R31-C
Brightness	400 cd/m²		900 cd/m²
Contrast Ratio	400 : 1 (typical)		1000 : 1 (typical)
DOT Clock	215 MHz		Same as R31 and R31-C
Response Time	50 ms (typical)		20 ms (typical)
Active Display Size(H x V)	318 x 424 mm		323.7 x 431.6 mm
Viewable ImageSize	Diagonal: 529 mm		Diagonal: 540 mm
LuminanceCalibration	Software (Optional)Photo-sensor (Optional)		Software (Optional)Photo-sensor (Optional)Digital UniformityEqualizer
Input Signals	DVI Standard 1.0		Same as R31 and R31-C
Input Terminals	DVI-D 24 pin		Same as R31 and R31-C
USB Ports /Standard	1 upstream, 2 downstream		Same as R31 and R31-C
Power	AC100-120V, 200-240V, 50/60Hz		Same as R31 and R31-C
PowerManagement	DVI-DMPM		Same as R31 and R31-C
Dimensions(W x H x D)	With Stand:368 x 515.5 mm- 597.5 x 209 mmWithout Stand:368 x 486 x 88.5 mm		Same as R31 and R31-C
Certifications &Standards	TUV/GM, CE Medical Device Directive, CB(EN60601-1), cTUVus (UL2601-1, CSAC22.2 No. 601-1), VCCI-B, FCC-B,Canadian ICES-003-A, CCC		CE (Medical DeviceDirective), TUV/GM(EN60601-1), cTUVus (UL60601-1, CSA C22.2 No.601-1), CB(IEC60601-1),VCCI-B, FCC-B, CanadianICES-003-B, c-Tick, RoHs

*The software used in RX320 is modified, refer to the "12. Information of Software used in RX320".

i : :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hiroaki Hashimoto Manager of Product Safety EIZO NANAO CORPORATION 153 Shimokashiwano-cho Hakusan, Ishikawa-ken 924-8566 JAPAN

JAN 2 8 2009

Re: K090045

Trade/Device Name: Color LCD Monitor, (RadiForce RX320) Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 6, 2009 Received: January 7, 2009

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 80); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-011
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-011
21 CFR 892.xxx	(Radiology)	(240) 276-012
Other		(240) 276-010

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.

Sincerely yours.

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

K090045

Color LCD Monitor, RadiForce RX320 Device Name :

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tom M. Whay

(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

5-1

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).