(28 days)
RadiForce GS310 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 GS310 is a 53cm (20.8") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
The provided text is a 510(k) summary for EIZO NANAO Corporation's RadiForce GS310 Monochrome LCD Monitor. This document is a premarket notification to the FDA, demonstrating that the new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain a study section with detailed acceptance criteria and performance data in the way a clinical trial report would for an AI-powered diagnostic device.
Instead, the "study" demonstrating the device meets acceptance criteria is a comparison to a predicate device (EIZO NANAO RadiForce G33, K052337). The acceptance criterion is "substantial equivalence" to the predicate device in terms of technical characteristics and general functions, especially for displaying and viewing digital images for diagnosis.
Here's an breakdown of the requested information based on the provided text, with explicit notes where the information is not available due to the nature of a 510(k) for a display monitor:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a medical display monitor), the "acceptance criteria" are generally that its technical specifications meet or exceed those of a legally marketed predicate device and are suitable for the intended use. The performance is gauged by direct comparison to the predicate.
| Characteristic | Acceptance Criteria (based on predicate G33) | Reported GS310 Performance | Notes |
|---|---|---|---|
| Panel Size and Type | 53 cm (20.8") TFT Monochrome LCD panel | 53 cm (20.8") TFT Monochrome LCD panel | Substantially equivalent. |
| Pixel Pitch | 0.207 x 0.207mm | 0.207 x 0.207mm | Substantially equivalent. |
| Grayscale Tones | 4,096 from a pallet of 8,161 | 1,024 from a pallet of 8,161 | Difference noted: GS310 employs fewer grayscale tones. The summary states: "GS310 employs smaller grayscale tones than that of G33. The sole modification is 3 bit ratio in sub-pixel opening areas for GS310." The implication is that despite fewer tones, the device is still considered substantially equivalent for its intended use, likely through other improvements or the assertion that 1,024 tones are sufficient. This is a key point of comparison. |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° | Substantially equivalent. |
| Native Resolutions | 1536 x 2048 (landscape/portrait) | 1536 x 2048 | Substantially equivalent. |
| Brightness | 700 cd/m² (Typical) | 700 cd/m² (Typical) | Substantially equivalent. |
| Contrast Ratio | 700: 1 (typical) | 900: 1 (typical) | Improvement noted: GS310 has a higher contrast ratio. This is a positive difference. |
| Luminance Calibration | Built-in swing calibration sensor provided | Built-in swing calibration sensor provided | Substantially equivalent. Others (e.g., certifications, input signals, physical dimensions) are also listed as substantially equivalent. |
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 (N/A) for a medical display monitor in this context. This 510(k) summary describes a hardware device (a monitor), not a software algorithm that processes medical data. The "test" for this device is primarily a comparison of its physical and technical specifications against a predicate device, rather than a performance study on a dataset of patient images. Therefore, there is no "test set" in the context of image data or patient cohorts.
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)
- N/A. Since there is no "test set" of medical images or patient data being processed, there were no experts establishing ground truth for such a set. The "ground truth" here is the established performance and safety of the predicate device and the technical standards for medical displays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method for a test set of medical images was used.
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. No MRMC study was performed. This device is a display monitor, not an AI-powered diagnostic tool, and therefore, it doesn't involve human readers "improving with AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device is a monitor, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. For this device, the "ground truth" for substantial equivalence is the established performance and safety profile of the predicate device (RadiForce G33) and adherence to general performance standards for medical display monitors. This is not derived from patient outcomes, pathology, or expert consensus on a dataset of images.
8. The sample size for the training set
- N/A. There is no "training set" as this is a hardware device (monitor), not a machine learning algorithm.
9. How the ground truth for the training set was established
- N/A. As there is no training set, there is no ground truth established for it.
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510(k) Summary as required by 807.92
- 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
APR 2 5 2006
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- Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
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- Date of Submission March 22, 2006
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- Device Trade name Monochrome LCD Monitor, RadiForce GS310
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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 : Monochrome LCD Monitor Device Name Model Name : RadiForce G33 510(k) No. : K052337
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- Description of Device
RadiForce GS310 is a 53cm (20.8") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
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- Intended Use
RadiForce GS310 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.
- Intended Use
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- Technological Characteristics
GS310 employs smaller grayscale tones than that of G33. The sole modification is 3 bit ratio in sub-pixel opening areas for GS310. 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.
- Technological Characteristics
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Appendix 1: Comparison Table with Predicate Device
| Items | G33 | GS310 |
|---|---|---|
| 510(k) Number | K052337 | Not known |
| Panel Size and Type | 53 cm (20.8") TFT MonochromeLCD panel | 53 cm (20.8") TFT MonochromeLCD panel |
| Cabinet Color | Black | Black |
| Pixel Pitch | 0.207 x 0.207mm | 0.207 x 0.207mm |
| Ratio of Sub-pixel | 4: 2: 1 | 4: 4: 4 |
| Opening Areas | ||
| Grayscale Tones | 4,096 from a pallet of 8,161 | 1,024 from a pallet of 8,161 |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency(H, V) | 31-100kHz, 48-71.5Hz(VGA Text: 69-71Hz)Frame synchronous mode: 59-61Hz | 31-100kHz, 48-71.5Hz(VGA Text: 69-71Hz)Frame synchronous mode: 59-61Hz |
| Native Resolutions | 1536 x 2048 (landscape)1536 x 2048 (portrait) | 1536 x 2048 |
| Brightness | 700 cd/m² (Typical) | 700 cd/m² (Typical) |
| Contrast Ratio | 700: 1 (typical) | 900: 1 (typical) |
| DOT Clock | 165 MHz | 165 MHz |
| Response Time | 50 ms (typical) | 50 ms (typical) |
| Active Display Size(H x V) | 318 x 424 mm | 318 x 424 mm |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 529 mm (20.8") (diagonal) |
| Luminance Calibration | Built-in swing calibration sensorprovided. | Built-in swing calibration sensorprovided. |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVU-D 24 pin | DVU-D 24 pin |
| USB Ports / Standard | 1 upstream, 2 downstream | 1 upstream, 2 downstream |
| Power | AC100-120V, 200-240V, 50/60Hz | AC100-120V, 200-240V, 50/60Hz |
| Power Management | DVI-DMPM | DVI-DMPM |
| 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:368 x 515.5 mm- 597.5 x 209 mmWithout Stand:368 x 486 x 90 mm |
| Certifications &Standards | TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL2601-1, CSA C22.2 No.601-1), VCCI-B, FCC-B, Canadian | TUV/GM, CE Medical DeviceDirective, CB (EN60601-1),cTUVus (UL2601-1, CSA C22.2 No.601-1), VCCI-B, FCC-B, Canadian |
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 5 2006
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation Engineering Management Section 153 Shimokashiwano, Hakusan, Ishikawa, 924-8566 JAPAN
Re: K060845
Trade/Device Name: Monochrome LCD Monitor, RadiForce GS310 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2006 Received: March 28, 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.
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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.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 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 (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
510(k) Number (if known): Not known K 06084 >
Monochrome LCD Monitor, RadiForce GS310 Device Name :
Indications For Use:
RadiForce GS310 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.
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)
Vancy C. Bunkin
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060845
§ 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).