(13 days)
RadiForce G33 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices must not be used for digital mammography system.
RadiForce G33 is a 53cm (20.8") Color LCD display for medical viewing. G33 displays high-definition medical imaging.
The provided text is a 510(k) summary for a medical display device, the EIZO RadiForce G33, from 2005. It focuses on demonstrating substantial equivalence to a predicate device (EIZO FC-2091) rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements for a study proving device performance are not present in the given document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for diagnostic performance, as might be found in a clinical study, is not directly applicable here. Instead, the "acceptance criteria" are implied by the comparison table to the predicate device, where the new device (G33) seeks to be substantially equivalent or improved in its technical specifications.
| Item | Acceptance Criteria (Predicate: FC-2091) | Reported Device Performance (G33) | Met? |
|---|---|---|---|
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 53 cm (20.8") TFT Monochrome LCD panel | Yes |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.207 x 0.207mm | Yes |
| Cabinet Color | Black | Black | Yes |
| Display Colors | 1,531 grayscale tones | 4,095 | Improved |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° | Yes |
| Scanning Freq. (H, V) | 92.86 - 96.72Hz, 60Hz | 31-100kHz, 48-71.5Hz (VGA Text: 69-71Hz) Frame synchronous mode: 59-61Hz | Changed, presumed acceptable |
| Native Resolutions | 2048 x 1536 (landscape), 1536 x 2048 (portrait) | 2048 x 1536 (landscape), 1536 x 2048 (portrait) | Yes |
| Brightness | 650 cd/m² | 700 cd/m² | Improved |
| Contrast Ratio | 600 : 1 (typical) | 700 : 1 (typical) | Improved |
| DOT Clock | 132MHz | 165MHz | Improved |
| Response Time | 50 ms (typical) | 50 ms (typical) | Yes |
| Active Display Size (H x V) | 424 mm x 318 mm | 318x424mm | Similar (portrait/landscape swap) |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 529 mm (20.8") (diagonal) | Yes |
| Luminance Calibration | Software (Optional), Photo-sensor (Optional), Protection panel (Optional) | Built-in swing calibration sensor provided. | Improved |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 | Yes |
| Input Terminals | DVI-D 24 pin | DVU-D 24 pin | Yes |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream | Similar |
| Power | 10V-120V/200V-240V, 50/60Hz, 0.7A-0.4A, 0.4-0.2A | AC100-120V, 200-240V, 50/60Hz | Similar |
| Power Management | DVI-DMPM | DVI-DMPM | Yes |
| Dimensions (W x H x D) | Varies by stand/no stand | Varies by stand/no stand | Similar |
| Certifications & Standards | TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A, VCCI-A | 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 | Updated/Similar |
Note: The primary "study" presented is a comparison against a predicate device to establish substantial equivalence based on technical characteristics, not a clinical trial of diagnostic accuracy.
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 submission describes hardware specifications and comparison to a predicate device, not a diagnostic performance study involving a test dataset of patient images.
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. No ground truth establishment from experts for image interpretation is described, as this is not a diagnostic algorithm.
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-powered diagnostic tool. The document does not describe a MRMC study.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance relies on its technical specifications meeting or exceeding those of the predicate device, as verified by engineering measurements and compliance with standards.
8. The sample size for the training set
Not applicable. This is not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable.
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510(k) Summary as required by 807.92
SEP - 8 2005 1. Company Identification EIZO NANAO CORPORATION 153 Shimokashiwano cho, Matto shi, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
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- Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
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- Date of Submission August 23, 2005
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- Device Trade name Monochrome LCD Monitor RadiForce G33
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- Common/Usual Name Image display system, medical image workstation, image monitor/display, and others
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- Classification Number Medical displays classified in Class II per 21 CFR 892.2050.
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- Predicate Device
Manufacturer : EIZO NANAO CORPORATION : 20.8" Monochrome LCD Monitor Device Name : FC-2091 Model Name : K022109 510(k) No.
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- Description of Device
Booronce G33 is a 53cm (20.8") Color LCD display for medical viewing. G33 displays high-definition medical imaging.
- Description of Device
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- Intended Use
RadiForce G33 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices must not be used for digital mammography system.
- Intended Use
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- Technological Characteristics
G33 employs the maximum resolution value larger than that of FC2091. Also, built in swing calibration sensor is equipped with G33 as a standard feature. Comparison table of the principal characteristics of 2 devices in Attachment 1 shows the new and predicate devices are substantially equivalent in the areas of technical characteristics, general function. Regarding to the change in software, refer to Software Information for RadiCX ver. 2.0 used for built in calibration sensor. The device does not come into contact with It does not control any life sustaining devices either. Any difference the patient. between both devices does not affect safety or efficacy.
- Technological Characteristics
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Appendix 1: Comparison Table with Predicate Device
| Items | FC-2091 | G33 |
|---|---|---|
| 510(k) Number | K022109 | Not known |
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 53 cm (20.8") TFT Monochrome LCD panel |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.207 x 0.207mm |
| Cabinet Color | Black | Black |
| Display Colors | 1.531 grayscale tones | 4,095 |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency (H, V) | 92.86 - 96.72Hz, 60Hz | 31-100kHz, 48-71.5Hz(VGA Text: 69-71Hz)Frame synchronous mode: 59-61Hz |
| Native Resolutions | 2048 x 1536 (landscape),1536 x 2048 (portrait) | 2048 x 1536 (landscape)1536 x 2048 (portrait) |
| Brightness | 650 cd/m² | 700 cd/m² |
| Contrast Ratio | 600 : 1 (typical) | 700 : 1 (typical) |
| DOT Clock | 132MHz | 165MHz |
| Response Time | 50 ms (typical) | 50 ms (typical) |
| Active Display Size (H x V) | 424 mm x 318 mm(16.7" x 12.5") | 318x424mm |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 529 mm (20.8") (diagonal) |
| Luminance Calibration | Software (Optional)Photo-sensor (Optional)Protection panel (Optional) | Built-in swing calibration sensor provided. |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVI-D 24 pin | DVU-D 24 pin |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream |
| Power | 10V-120V/200V-240V, 50/60Hz,0.7A-0.4A, 0.4-0.2A | AC100-120V, 200-240V, 50/60Hz |
| Power Management | DVI-DMPM | DVI-DMPM |
| Dimensions (W x H x D) | With Stand:368 mm x 520 - 592mm x 209 mm(14.5" x 20.5" x 23.3" x 8.2")Without Stand:368 mm x 474 mm x 84 mm(14.5" x 18.7" x 3.3") | With Stand:368 x 515.5 mm597.5 x 209 mmWithout Stand:368 x 486 x 90 mm |
| Certifications & Standards | TUV/GM, CE, CB, EN60601-1,UL2601-1, CSA C22.2 No. 601-1,FCC-A, Canadian ICES-003-A,VCCI-A | 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 |
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three lines extending from its head, resembling wings or feathers. The seal is black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eizo Nanao Corporation % Mr. Shinich Yamanaka Reviewer Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun, Mie-ken 519-05 JAPAN
SEP - 8 2005
Re: K052337 Trade/Device Name: Monochrome LCD Monitor RadiForce G33 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 23, 2005
Received: August 26, 2005
Dear Mr. Yamanaka:
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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegn manceing of substantial equivalence of your device to a legally premarket nothleation. The I DA mining of our 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 If you desire specific advice tor your de for of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entires, " coses on on your responsibilities under the Act from the 807.97). I ou may obtain other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
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 STATEMENT
Ko52337 510(k) Number (if known): Not known
Monochrome LCD Monitor, RadiForce G33 Device Name
Indications For Use:
RadiForce G33 is intended to be used in displaying and viewing digital images for diagnosis of Kadirore Good is milended to be docum anspiring and half a group must not be used for digital mammography system.
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)
Nancy Broden
(Division Sign-Off) 0.
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052337
§ 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).