The RadiForce Large Monitor System is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.

Device Description

The system consists of the following components:

LS560W Large Monitor Model No. 6GF6200-8A$## mandatory component
LMM56800 Large Monitor Manager Model No. 6GF6020-1A$## mandatory component
PDC0100 Analog DVI Converter -- Model No. 6GF6010-0B$## -- optional accessory
PDS0800 DV! Splitter/Scaler Model No. 6GF6020-0AA00-#$$# optional accessory
TDL3600 Transmission Link Model No. 6GF6010-#$$## optional accessory
CID1000P Control Interface Device 6GF6550-2H$## optional accessory
Cabinet optional accessory

where "$" signifies a letter from A to Z, and "#" a number from 0 to 9.

The RadiForce Large Monitor System is a large color flat panel monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. To appreciate all of the advantages of the large widescreen monitor, the data has to be collected from the various sources and prepared for variable viewing. This is handled by the mandatory "Large Monitor Manager" ("LMM"). In some reports or references you will find the "LMM" being called "MDM" for "Multi Display Manager" (customer specific product name). The various video sources are being bundled using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines.

Control of the video sources can also be accomplished using Eizo's Control Interface Device CID as optional part of the system or any other standard browser compatible operator console.

The RadiForce Large Monitor System uses a color LCD panel employing Multi-domain Vertical Alignment (MVA) technology to allow wide viewing angles. It has a resolution of 3840 x 2160 pixels and is used in landscape mode.

The various video sources from medical and other devices are being collected using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines. An optional external operator console (Control Interface Device CID) can be used as optional part of the system to rearrange pictures from the regarding sources or switch between numerous presets according to specific user's needs.

The RadiForce Large Monitor System may be offered in different housing colors and with different logos. These are cosmetic differences and of no effect on the function and performance of the system.

AI/ML Overview

The provided text describes the EIZO RadiForce Large Monitor System, but it does not contain details about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance or diagnostic accuracy.

The document focuses on:

Device Description and Intended Use: A large color flat panel monitor system for integrating and displaying video from various medical instruments.
Technological Characteristics: Resolution, panel technology, and how it handles multiple video sources.
Performance Testing (Compliance): Verification that the system complies with certain standards (NEMA DICOM, IEC, UL, FCC) for electrical safety and electromagnetic compatibility.
Substantial Equivalence: A claim that the device is substantially equivalent to a predicate device (Cardio-View, K083321) regarding technical characteristics, application, and intended use, and that differences do not affect safety or effectiveness.

Therefore, many of the requested sections about acceptance criteria, clinical study details, sample sizes, ground truth, and expert involvement cannot be extracted.

Here's a breakdown of what can be inferred from the text based on the provided categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Grayscale Standard Display Function	Compliance with NEMA's PS 3.14 DICOM standard. (Though no precise pass/fail criterion is stated in the document, compliance to the standard is implied as the criterion).	"The RadiForce Large Monitor was successfully tested to comply with NEMA's PS 3.14 DICOM standard (Grayscale Standard Display Function)." "We consider the compliance to be excellent because of the very close proximity of the measured values towards the ideal curve represented by the Barten model."
System Functionality	The system performs in accordance with its specifications.	"EIZO GmbH performed a range of system and performance tests to ensure that the RadiForce Large Monitor System performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a large color flat panel display system." "A system test was conducted successfully on the RadiForce Large Monitor System, including MDM/LMM, Large Monitor, FPGA + Bootsoftware + Firmware, photometers SSM and ASLM."
Electrical Safety	Compliance with relevant electrical safety standards.	Certified to IEC 60601-1 for Large Monitor, Transmission Link and CID; IEC 60950-1 for CID and Converterbox; UL 60950-1 for MDM/LMM and Splitter; IEC 60601-1-1 for Large Monitor System. "Thus the electrical safety...of the system and its components could be verified by third party laboratories."
Electromagnetic Compatibility (EMC)	Compliance with relevant electromagnetic compatibility standards.	Certified to IEC 60601-1-2 for CID, Converterbox and Large Monitor; FCC Part 15, subpart B for Large Monitor System; IEC 60601-1-2 (radiated emissions only) for Large Monitor System. "Thus the...electromagnetic compatibility of the system and its components could be verified by third party laboratories."
Substantial Equivalence	Functionality and safety/effectiveness are comparable to the predicate device.	"The RadiForce Large Monitor System is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. All functions of the Radiforce Large Monitor System are identical to the predicate device. Any differences between the devices do not affect safety or effectiveness."

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

Not Applicable. The document describes engineering/compliance testing of a display device, not a clinical study involving a "test set" of patient data. The "test set" in this context would refer to internal company "system and performance tests" without specifying sample sizes or data provenance.

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

Not Applicable. This information is not provided because the testing described is not related to establishing clinical ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not Applicable. This information is not provided.

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

Not Applicable. No MRMC or human-in-the-loop study is mentioned. This device is a display monitor, not an AI diagnostic algorithm.

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

Not Applicable. This device is a display monitor, not an algorithm.

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

For the DICOM compliance test, the "ground truth" is the ideal curve represented by the Barten model.
For safety and EMC tests, the "ground truth" is compliance with the specified international standards (IEC, UL, FCC).
For system functionality, the "ground truth" is the device's own specifications.

8. The sample size for the training set

Not Applicable. This device does not use a "training set" in the context of machine learning.

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

Not Applicable. This device does not have a "training set."

Summary

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K112645 P1/3

SEP 2 2 2011

20P2
œ4. .0o0

Eizo GmbH, Siemensallee 84, 76187 Karlsruhe

Name Department

Telephone

Guenter Michael Volz QM

+49 (721) 20321-282 +49 (721) 20321-478 guenter.volz@eizo.com

E-Mail Date

Fax

5/30/2011

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

1. Date of Summary

5/30/2011

2. Company

EIZO GmbH Siemensallee 84 D-76187 Karlsruhe, Germany

3. Authorized Contact Person

Guenter Michael Volz

4. Device Information

Trade Name/Model: RadiForce Large Monitor System .
Common Name: RadiForce Large Monitor System ●
- Classification Name: Display, Cathode-Ray Tube, Medical
Classification Number: 21 CFR 870.2450, Product Code DXJ .

5. Predicate Device

Cardio-View (K083321) ●

6. Device Description

The system consists of the following components:

LS560W Large Monitor Model No. 6GF6200-8A$## mandatory component �
LMM56800 Large Monitor Manager Model No. 6GF6020-1A$## mandatory component �
PDC0100 Analog DVI Converter -- Model No. 6GF6010-0B$## -- optional accessory �
PDS0800 DV! Splitter/Scaler Model No. 6GF6020-0AA00-#$$# optional accessory �
TDL3600 Transmission Link Model No. 6GF6010-#$$## optional accessory ◆
CID1000P Control Interface Device 6GF6550-2H$## optional accessory �
Cabinet optional accessory �

where "$" signifies a letter from A to Z, and "#" a number from 0 to 9.

Office/Delivery address: Eizo GmbH Siemensallee 84 76187 Karlsruhe Tel.: +49 (721) 20321-000 Fax: +49 (721) 20321-000 Postal address: Elzo GmbH 76181 Karlsruhe

Internet: http://www.eizo.eu

Management: Peter Ziegler

Commercial registries: Karlsruhe Registergericht: Mannheim HRB 703009 WEEE-Reg-Nr. DE 75807507

Tab 1 - 510(k) Summary

Section-05: Page 1 of 3

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Image /page/1/Picture/0 description: The image contains handwritten text that appears to be an identifier or code. The text reads "K112645 P2/3". The characters are written in a clear, legible manner, with distinct spacing between the alphanumeric components.

Image /page/1/Picture/1 description: The image shows a logo with the word "EIZO" in a stylized font at the bottom. Above the word is a square graphic that resembles a checkered cloth or a pixelated design. The checkered pattern consists of alternating dark and light squares, creating a visually textured effect. The overall design is simple and geometric, with a focus on the contrast between the black and white elements.

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

Control of the video sources can also be accomplished using Eizo's Control Interface Device CID as optional part of the system or any other standard browser compatible operator console.

7. Intended Use

The RadiForce Large Monitor System is intended to be used by health care professionals to integrate the video output from various commercially available instruments commonly used in a medical procedure laboratory into a single video display.

8. Technological Characteristics

The RadiForce Large Monitor System may be offered in different housing colors and with different logos. These are cosmetic differences and of no effect on the function and performance of the system.

Regarding the comparison of the intended use of the two large monitor systems both address the benefit of image integration and management.

It enables the clinician to fully customize captured image sources and their arrangement due to the specific situational needs. Switching between different layouts and thus reprioritizing the images takes only milliseconds.

The overall design of the display and the Large Monitor Manager processor were validated in accordance with internationally recognized safety and EMC standards by independent testing facilities.

EIZO GmbH.performed a range of system and performance tests to ensure that the RadiForce Large Monitor System performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a large color flat panel display system.

As with the predicate device, the RadiForce Large Monitor System was designed to receive and display images from standard, commercial DVI and analog display controllers.

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KII 2645

Image /page/2/Picture/1 description: The image is a logo for EIZO. The logo features a checkered square above the word "EIZO". The checkered square is tilted at an angle, and the word "EIZO" is in a bold, sans-serif font.

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

9. Performance Testing

The RadiForce Large Monitor was successfully tested to comply with NEMA's PS 3.14 DICOM standard (Grayscale Standard Display Function).

Though there is no precise passffail criterion present within the DICOM standard, we consider the compliance to be excellent because of the very close proximity of the measured values towards the ideal curve represented by the Barten model.

A system test was conducted successfully on the RadiForce Large Monitor System, including MDM/LMM, Large Monitor, FPGA + Bootsoftware + Firmware, photometers SSM and ASLM.

Moreover, each component of the system has been certified seperately and as a working unit (Large Monitor System) according to following standards:

Large Monitor, Transmission Link and CID:	IEC 60601-1
CID and Converterbox:	IEC 60950-1
MDM/LMM and Splitter:	UL 60950-1
Large Monitor System:	IEC 60601-1-1
CID, Converterbox and Large Monitor	IEC 60601-1-2
Large Monitor System:	FCC Part 15, subpart B
Large Monitor System:	IEC 60601-1-2, radiated emissions only

Thus the electrical safety and electromagnetic compatibility of the system and its components could be verified by third party laboratories.

10. Conclusions

The RadiForce Large Monitor System is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. All functions of the Radiforce Large Monitor System are identical to the predicate device. Any differences between the devices do not affect safety or effectiveness.

The 510(k) Pre-Market Notification for the RadiForce Large Monitor System contains sufficient information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line representing the staff. The text "U.S. Department of Health & Human Services" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 16903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

EIZO GmbH c/o Mr. Bhavesh V. Sheth Intertek Testing Services NA. Inc. 2307 E Aurora Rd. Unit B7 Twinsburg, OH 44087

SEP 2 2 2 2011

Re: K112645

Trade/Device Name: RadiForce Large Monitor Svstem Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II (two) Product Codes: DXJ Dated: September 3, 2011 Received: September 12, 2011

Dear Mr. Sheth:

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 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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Page 2 - Mr. Bhavesh V. Sheth

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.hun 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: RadiForce Large Monitor System

Indications For Use: The RadiForce Large Monitor System is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.

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

Over-The-Counter Use (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)

sion Sian-Off) vision of Cardiovascular Devices

510(k) Number K112645

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).