RadiForce GS320 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.

Device Description

RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.

AI/ML Overview

The provided document is a 510(k) summary for a medical display monitor (EIZO NANAO CORPORATION Monochrome LCD Monitor, RadiForce GS320), not a device that utilizes AI or provides diagnostic interpretations. Therefore, many of the requested fields regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of device and are not present in the submission.

The 510(k) process for a monitor like this focuses on demonstrating substantial equivalence to a predicate device through technical specifications and intended use, rather than clinical performance studies that directly assess AI accuracy or human reader improvement.

Here's the information that can be extracted or noted as not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical display monitors, "acceptance criteria" and "reported device performance" are typically defined by technical specifications and adherence to standards, rather than clinical accuracy metrics. The comparison is primarily against a predicate device's technical specifications.

Characteristic	Acceptance Criteria (Predicate Device K060845 - RadiForce G310)	Reported Device Performance (RadiForce GS320)
Panel Size and Type	53 cm (20.8") TFT Monochrome LCD panel	54 cm (21.3") TFT Monochrome LCD panel
Pixel Pitch	0.207 x 0.207mm	0.2115 x 0.2115mm
Ratio of Sub-pixel Opening Areas	4: 4: 4	Same as predicate
Grayscale Tones	1,024 from a pallet of 8,161	Same as predicate
Viewing Angles	H: 170°, V: 170°	Same as predicate
Scanning Frequency (H, V)	31-100kHz, 48-71.5Hz (VGA Text: 69-71Hz) Frame synchronous mode: 59-61Hz	Same as predicate
Native Resolutions	1536 x 2048	Same as predicate
Brightness	700 cd/m² (Typical)	Same as predicate
Contrast Ratio	900: 1 (typical)	850: 1 (typical)
DOT Clock	165 MHz	Same as predicate
Response Time	50 ms (typical)	Same as predicate
Active Display Size (H x V)	318 x 424 mm	324 x 433 mm
Viewable Image Size	529 mm (20.8") (diagonal)	541mm (21.3") (diagonal)
Luminance Calibration	Built-in swing calibration sensor provided	Same as predicate
Input Signals	DVI Standard 1.0	Same as predicate
Input Terminals	DVU-D 24 pin	Same as predicate
USB Ports / Standard	1 upstream, 2 downstream	1 upstream, 2 downstream/Standard Rev.2.0
Power	AC100-120V, 200-240V, 50/60Hz	Same as predicate
Power Management	DVI-DMPM	Same as predicate
Dimensions (W x H x D)	With Stand: 368 x 515.5 mm – 597.5 x 209 mm Without Stand: 368 x 486 x 90 mm	With Stand: 376 x 522.5 mm – 604.5x 208.5 mm Without Stand: 376 x 500 x 92 mm
Certifications & Standards	TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus (UL2601-1, CSA C22.2 No. 601-1), VCCI-B, FCC-B, Canadian ICES-003-A, CCC	Same as predicate

The key acceptance criterion here is demonstrating "substantial equivalence" to the predicate device (RadiForce G310, K060845), meaning the new device has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness. The reported performance of the GS320 is compared directly against the specifications of the GS310. The submission states: "Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions." The modifications noted are a slightly larger panel size and a lower contrast ratio, with the submission implicitly arguing these do not negate substantial equivalence for the intended use.

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

N/A. This is a medical display monitor, not an AI or diagnostic device that would typically undergo testing with a "test set" of patient data. The evaluation is based on engineering specifications and comparison to a predicate device.

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

N/A. No ground truth or expert evaluation of diagnostic performance is mentioned or required for this type of device submission.

4. Adjudication method for the test set

N/A. No test set for diagnostic performance is mentioned.

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

N/A. This is not an AI-assisted device.

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

N/A. This is a medical display monitor, not an algorithm.

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

N/A. Ground truth is not relevant for a medical display monitor's 510(k) submission, which focuses on technical specifications and substantial equivalence.

8. The sample size for the training set

N/A. This device does not involve a training set as it's a hardware monitor, not a machine learning algorithm.

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

N/A. Not applicable for a hardware device.

Summary

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K062053

510(k) Summary as required by 807.92

AUG - 7 2006

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

1. Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
1. Date of Submission June 28, 2006
1. Device Trade name Monochrome LCD Monitor, RadiForce GS320
1. 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.

1. Predicate Device

Manufacturer	:	EIZO NANAO CORPORATION
Device Name	:	Monochrome LCD Monitor
Model Name	:	RadiForce G310
510(k) No.	:	K060845
Items	GS310	GS320
510(k) Number	K060845	Not known
Panel Size and Type	53 cm (20.8") TFT MonochromeLCD panel	54 cm (21.3") TFT MonochromeLCD panel
Cabinet Color	Black	It is same as the following.
Pixel Pitch	0.207 x 0.207mm	0.2115 x 0.2115mm
Ratio of Sub-pixelOpening Areas	4: 4: 4	It is same as the following.
Grayscale Tones	1,024 from a pallet of 8,161	It is same as the following.
Viewing Angles	H: 170°, V: 170°	It is same as the following.
Scanning Frequency(H, V)	31-100kHz, 48-71.5Hz(VGA Text: 69-71Hz)Frame synchronous mode: 59-61Hz	It is same as the following.
Native Resolutions	1536 x 2048	It is same as the following.
Brightness	700 cd/m² (Typical)	It is same as the following.
Contrast Ratio	900: 1 (typical)	850: 1 (typical)
DOT Clock	165 MHz	It is same as the following.
Response Time	50 ms (typical)	It is same as the following.
Active Display Size(H x V)	318 x 424 mm	324 x 433 mm
Viewable Image Size	529 mm (20.8") (diagonal)	541mm (21.3") (diagonal)
Luminance Calibration	Built-in swing calibration sensorprovided.	It is same as the following.
Input Signals	DVI Standard 1.0	It is same as the following.
Input Terminals	DVU-D 24 pin	It is same as the following.
USB Ports / Standard	1 upstream, 2 downstream	1 upstream, 2downstream/Standard Rev.2.0
Power	AC100-120V, 200-240V, 50/60Hz	It is same as the following.
Power Management	DVI-DMPM	It is same as the following.
Dimensions (W x H x D)	With Stand:368 x 515.5 mm– 597.5 x 209 mmWithout Stand:368 x 486 x 90 mm	With Stand:376 x 522.5 mm– 604.5x 208.5 mmWithout Stand:376 x 500 x 92 mm
Certifications &Standards	TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL2601-1, CSA C22.2 No.601-1), VCCI-B, FCC-B, CanadianICES-003-A, CCC	TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL2601-1, CSA C22.2 No.601-1), VCCI-B, FCC-B, CanadianICES-003-A, CCC

8. Description of Device

RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.

1. Intended Use
  RadiForce GS320 is intended to be used in displaying and viewing digital images for diagnosis of Xray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

10. Technological Characteristics

GS320 employs smaller grayscale tones than that of GS310. The only modification is that the panel size became big with 54cm(21.3") from 53cm(20.8"). Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions.

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・

Appendix 1: Comparison Table with Predicate Device

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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 eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 7 2006

Mr. Hiraoki Hashimoto Manager of Engineering Management Section EIZO NANAO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 JAPAN

Re: K062053

Trade/Device Name: Monochrome LCD Monitor, RadiForce GS320 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 3, 2006 Received: July 20, 2006

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive, followed by three stars. The text around the circle reads "U.S. Food and Drug Administration".

Protecting and Promoting Public Health

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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 (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 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). 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,

Nancy C. Hogdon

Nancy C. Brogdon 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 (if known): Not known

K042053

Device Name : Monochrome LCD Monitor, RadiForce GS320

Indications For Use:

Prescription Use (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)

David A. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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).