RadiForce RS110 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RS110 does not support the display of mammography images for diagnosis.

Device Description

RadiForce RS110 is a 48cm (19") Color LCD display for medical image viewing. RS110 displays high-definition medical imaging.

AI/ML Overview

This document is a 510(k) summary for the EIZO RadiForce RS110 Color LCD Monitor. It outlines the device's characteristics and its substantial equivalence to a predicate device (RadiForce R12).

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically described for a medical imaging algorithm or diagnostic device. This document describes a monitor, which is a display device, not a diagnostic algorithm. Therefore, many of the typical acceptance criteria and study parameters you asked for (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable or detailed in this type of submission for a display monitor.

Instead, the "acceptance criteria" for a medical display device like this are primarily related to its technical specifications and performance characteristics, and the "study" proving it meets these involves technical measurements and comparisons to a predicate device.

Here's an interpretation based on the provided text, addressing your points where possible and noting where information is not available or not applicable:

1. Table of acceptance criteria and the reported device performance

For a medical display monitor like the RadiForce RS110, the "acceptance criteria" are implicitly its ability to meet or exceed the performance specifications of the predicate device (RadiForce R12) and comply with general medical display standards. The reported performance is highlighted by the comparison table itself.

Acceptance Criteria (Implied: Match/Exceed Predicate)	Reported Device Performance (RadiForce RS110)
Panel Size and Type: 48cm (19")	Same as R12 (48cm (19"))
Pixel Pitch: 0.294 mm x 0.294 mm	Same as R12 (0.294 mm x 0.294 mm)
Display Colors: 16.77 million from 1.06 billion palette	Same as R12 (16.77 million from 1.06 billion palette)
Viewing Angles: H: 170°, V: 170° (Predicate)	Improved: H: 176°, V: 176°
Native Resolutions: 1280 x 1024	Same as R12 (1280 x 1024)
Brightness: 270 cd/m² (Predicate)	Improved: 290 cd/m²
Contrast Ratio: 450 : 1 (typical) (Predicate)	Improved: 800 : 1 (typical)
Response Time: 20 ms (typical) (Predicate)	25 ms (typical)
Input Terminals: DVI-D 29 pin x 2 (Predicate)	D-Sub mini 15pin, DVI-I 29pin (switchable) (Modified)
Power Consumption: 60 watts (typical) (Predicate)	Improved: 55 watts
Power Save Mode: Less than 8 watts (Predicate)	Improved: Less than 1.3 watts
Certifications & Standards: (Specifics listed for R12)	Updated and expanded list for RS110, including CE (Medical Device Directive), cTUVus (UL 60601-1, CSA C22.2 No. 601-1), VCCI-B, FCC-B, Canadian ICES-003-B, c-Tick, EPA ENERGY STAR®, EIZO Products 2009, RoHS
Intended Use: Displaying and viewing digital images for diagnosis of X-ray or MRI, etc., excluding mammography.	Identical for RS110.

Study that proves the device meets the acceptance criteria:

The study is an equivalence demonstration by comparing the technical specifications of the new device (RS110) against a legally marketed predicate device (R12). The "study" is the detailed comparison table provided in Appendix 1, which shows that the RS110 either maintains or improves upon the performance characteristics of the R12, while maintaining the same intended use.

Specifically, the document states: "RadiForce R12 is substantially equivalent to RS110 employs the maximum resolution values same as that of R12. RS110 improved the brightness, contrast and viewing angle of the LCD module, and modified the calibration software." This forms the basis of their claim of equivalence and meeting (or exceeding) the implied acceptance criteria.

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

This information is not applicable and therefore not provided in this 510(k) for a display monitor. There is no "test set" of medical images in the context of an algorithm's diagnostic performance. The testing here is of the monitor's physical and optical properties.

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 applicable. Ground truth, expert consensus, and radiologists are relevant for evaluating diagnostic algorithms, not for the technical specifications of a display monitor. The "ground truth" for a monitor is its measured physical performance characteristics.

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

This information is not applicable. Adjudication methods are used in diagnostic studies, not for the technical evaluation of a monitor's specifications.

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

This information is not applicable. MRMC studies are for evaluating the impact of a diagnostic tool (like AI) on reader performance. This document is for a display monitor, which is a passive viewing instrument.

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

This information is not applicable. This is not an algorithm; it's a hardware display device.

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

The "ground truth" for a display monitor's performance is essentially the physical measurements of its technical specifications (brightness, contrast, viewing angles, resolution, power consumption, etc.) using calibrated equipment and standard test patterns. These measurements are then compared against the predicate device's specifications and relevant industry standards for medical displays.

8. The sample size for the training set

This information is not applicable. Training sets are used for machine learning algorithms. This device is a display monitor.

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

This information is not applicable. As there is no training set for a display monitor, there's no ground truth for it to be established either.

Summary

{0}------------------------------------------------

510(k) Summarv as required by 807.92

K082663

OCT 0 6 2008

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

2. Official Correspondent

Hiroaki Hashimoto (Mr.) Manager of Product Safety

3. Date of Submission

September 11, 2008

4. Device Trade name

Color LCD Monitor, RadiForce RS110

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 : RadiForce R12 Model Name 510(k) No. : K040982

8. Description of Device

RadiForce RS110 is a 48cm (19") Color LCD display for medical image viewing. RS110 displays high-definition medical imaging.

9. Intended Use

10. Technological Characteristics

RadiForce R12 is substantially equivalent to RS110 employs the maximum resolution values same as that of R12. RS110 improved the brightness, contrast and viewing angle of the LCD module, and modified the calibration software. The brightness improved in 290 cd/m2 from 270cd/m2. The contrast improved by it.

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

{1}------------------------------------------------

Items	R12	RS110
510(k) Number	K040982	Not Known
Panel Size and Type	48cm (19")	Same as R12
Pixel Pitch	0.294 mm x 0.294 mm	Same as R12
Available Cabinet Colors	Black	Same as R12
Display Colors	16.77 million from a palette of 1.06billion colors	Same as R12
Viewing Angles	H: 170°, V: 170°	H: 176°, V: 176°
Scanning Frequency(H, V)	Digital: 30-65kHz 59-61Hz(VGA Text:65-71Hz)Analog: 30-82kHz 49-86Hz(1280 x 1024 : 49-76Hz)Frame synchronous mode:57.5-62Hz	Same as R12
Native Resolutions	1280 x 1024	Same as R12
Brightness	270 cd/m²	290 cd/m²
Contrast Ratio	450 : 1 (typical)	800 : 1 (typical)
DOT Clock	Digital 108 MHz, Analog: 135 MHz	Same as R12
Response Time	20 ms (typical)	25 ms (typical)
Input Signals	Digital: DVI Standard 1.0,Analog: RGB Analog	Same as R12
Input Terminals	DVI-D 29 pin x 2	D-Sub mini 15pin, DVI-I 29pin(swichable)
USB Ports / Standard	1 upstream, 2 downstream / Rev.2.0	Same as R12
Active Display Size(H x V)	376.3 mm x 301.0 mm	Same as R12
Viewable Image Size	481 mm (diagonal)	Same as R12
Luminance Calibration	Software (Optional)Photo-sensor (Optional)	Same as R12
Power	AC100-120V/200-240V, 50/60Hz	Same as R12
Power Management	DVI-DMPMVESA DMPM	Same as R12
Power Consumption	60 watts (typical)	55 watts
Power Save Mode	Less than 8 watts	Less than 1.3 watts
Dimensions(W x H x D)	With Stand:414 x 409.5 - 509.5 x 203 mmWithout Stand:414 x 340 x 64 mm	Same as R12
NET Weight	With Stand: 8.1 kgWithout Stand: 5.8 kg	With Stand: 7.6 kgWithout Stand: 5.3 kg
Certifications &Standards	TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL2601-1, CSA C22.2No. 601-1), FCC-B, CanadianICES-003-B, VCCI-B, EIZO ECOProducts 2002	CE (Medical Device Directive),TUV/GM (EN60601-1), cTUVus(UL 60601-1, CSA C22.2 No.601-1), VCCI-B, FCC-B,Canadian ICES-003-B, c-Tick,EPA ENAERGY STAR®, EIZOProducts 2009, RoHS

Appendix 1: Comparison Table with Predicate Device

*The software used in RS110 is modified, refer to the "12. Information of Software used in
RS110".

and the contraction of the comments of

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 6 2008

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

Re: K082663

Trade/Device Name: Color LCD Monitor, RadiForce RS110 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 11, 2008 Received: September 12, 2008

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.

{3}------------------------------------------------

Page 2

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 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 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)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Manufacturers, 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/support/index.html.

Sincerely yours,

forpe M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number: KOS2663

Color LCD Monitor, RadiForce RS110 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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number, K082663

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).