RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce MX241W does not support the display of mammography images for diagnosis.

Device Description

RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing.

AI/ML Overview

The provided text is for a 510(k) summary for a medical display monitor (EIZO RadiForce MX241W). This type of device is a display monitor, not an AI-powered diagnostic device, and therefore the kind of study and acceptance criteria you are asking for (e.g., related to algorithm performance, expert evaluations, MRMC studies, ground truth) are not applicable or typically part of the regulatory submission for such a display device.

The 510(k) submission for a medical display focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical specifications and intended use.

Here's a breakdown based on the information available and what is typically expected for this type of device:

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

For a medical display, acceptance criteria typically revolve around technical specifications such as brightness, contrast ratio, resolution, color accuracy, and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function). The submission primarily highlights improvements over the predicate device.

Acceptance Criteria (Implied / Compared to Predicate)	Reported Device Performance (RadiForce MX241W)
Panel Size (compared to predicate)	61cm (24.1")
Brightness (compared to predicate)	320 cd/m2
Input Terminals (newly added)	DisplayPort
Intended Use	Displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners (not for digital mammography).
Classification	Class II (21 CFR 892.2050 - Medical displays)

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

Not applicable. This is a medical display device, not an image analysis or diagnostic software. Therefore, there is no "test set" of medical data in the context of diagnostic performance evaluation. The "testing" would involve electrical and optical performance measurements of the display itself.

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)

Not applicable, as there is no "ground truth" to establish for a display device in the same way there would be for a diagnostic algorithm. Performance is based on technical specifications and adherence to standards.

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

Not applicable.

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. This device is a display monitor, not an AI or CAD system, so an MRMC study is not relevant.

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

Not applicable. This is hardware (a monitor), not an algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary

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K092 741

510(k) Summary as required by 807.92

1. Company Identification
  NOV 1 0 2009

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

1. Official Correspondent
  Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section

Date of Submission

September 4, 2009

1. Device Trade name Color LCD Monitor, RadiForce MX241W
1. Common/Usual Name:

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

1. 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		: FlexScan MX300W
510(k) No.		: K073340

1. Description of Device
  RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing.
1. Intended Use
  RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
1. Substantial Equivalence to Predicate Device
  RadiForce MX241W is substantially equivalent to FlexScan MX300W (K073340). The panel size is changed to 61 cm (24.1") from 76cm (29.8"). MX241W improved the brightness. The brightness improved to 320 cd/m2 from 300 cd/m2. DisplayPort is added as new input terminal.

Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1. Appendix 1: Comparison Table with Predicate Device

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized eagle. The eagle is depicted with its wings spread, and its head turned to the left. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

NOV 1 0 2009

Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation, Engineering Management Section 153 Shimokashiwano-cho, Hakusan, Ishikawa-ken 924-8566 JAPAN

Re: K092741

Trade/Device Name: Color LCD Monitor, RadiForce MX241W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21, 2009 Received: October 22, 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 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.

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

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Page 2 -

Enclosure

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

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/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/MedicalDevices/Resourcesfor You/Industry/default.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

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Indications for Use

K092741

(k) Number:

K092741

ëvice Name . . Color LCD Monitor, RadiForce MX241W

dications for Use:

RadiForce MX241W is intended to be used in displaying and viewing digital images for Radil ore MX24117 - Is there and medical practitioners. RadiForce MX241W does not support the display of mammography images for diagnosis.

escription Use art 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Aorri m. Wh

Division of Reproductive, Abdominal and Radiological Dev 510(k) Number

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).