(29 days)
RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.
RadiForce RX211 is a 54cm (21.3") Color LCD display for medical image viewing. RX211 displays high-definition medical imaging.
The provided document is a 510(k) summary for a medical display monitor (Color LCD Monitor, RadiForce RX211), not an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance, ground truth, and study design (e.g., MRMC studies, standalone performance, training sets) is not applicable or present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device (RadiForce RX210) by comparing technological characteristics, primarily brightness and contrast.
Here's an attempt to answer the applicable questions based on the provided text, with clarifications where the information is not relevant to this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI algorithm. Instead, it compares the technological characteristics of the new device (RX211) to its predicate device (RX210) to demonstrate substantial equivalence. The "performance" here refers to specific technical specifications.
| Characteristic | Acceptance Criteria (Predicate Device RX210) | Reported Device Performance (RX211) |
|---|---|---|
| Brightness | 600 cd/m2 | 750 cd/m2 |
| Contrast | (Improved from RX210) | (Improved from RX210) |
| Maximum Resolution | Same as RX210 | Same as RX210 (implied) |
| Software | (Predicate's software) | Modified |
Note: The document states "The brightness improved in 750 cd/m2 from 600 cd/m2. The contrast improved by it." indicating an improvement over the predicate, which serves as the "acceptance" benchmark for equivalence in this context.
2. Sample size used for the test set and the data provenance
The concept of a "test set" in the context of an AI/ML study is not applicable here. This is a hardware device review. There are no images or clinical data used as a "test set" for performance evaluation in this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert consensus are irrelevant for a medical display monitor's technical specifications.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication performed in this context.
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 is a medical display monitor, not an AI-assisted diagnostic device. Therefore, no MRMC study looking at human reader improvement with AI was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used
Not applicable. Ground truth is not a concept used in the regulatory review of a medical display monitor's technical specifications.
8. The sample size for the training set
Not applicable. There is no training set for a medical display monitor.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth for a medical display monitor.
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MAR 2 0 2008
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
2. Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
3. Date of Submission February 19, 2008
- Device Trade name Color LCD Monitor, RadiForce RX211
5. 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.
7. Predicate Device
| Manufacturer | : EIZO NANAO CORPORATION |
|---|---|
| Device Name | : Color LCD Monitor |
| Model Name | : RadiForce RX210 |
| 510(k) No. | : K063120 |
8. Description of Device
RadiForce RX211 is a 54cm (21.3") Color LCD display for medical image viewing. RX211 displays high-definition medical imaging.
9. Intended Use
RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.
10. Technological Characteristics
RadiForce RX211 is substantially equivalent to RX210. RX211 employs the maximum resolution values same as that of RX210. RX211 improved the brightness of the LCD module, and modified the software. The brightness improved in 750 cd/m2 from 600 cd/m2. The contrast improved by it.
Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.
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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 features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Hiroaki Hashimoto EIZO NANAO CORPORATION Engineering Management Section
Re: K080457
153 Shimokashiwano-cho
Hakusan Ishikawa-ken 924-8566
Manager
JAPAN
Trade/Device Name: Color LCD Monitor, (RadiForce RX211) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2008 Received: February 20, 2008
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.
MAR 2 0 2008
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/1/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" in the middle. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located at the bottom of the logo. The text around the circle reads "The Nation's Food Protection Agency".
moting Public J
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of action that I bromination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or urf I vature 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 OI It Fat 607), incoming (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 11 you user for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's (210) of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain (1) = 1 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 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/cdrb/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:
Color LCD Monitor, RadiForce RX211 Device Name :
Indications for Use:
RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.
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)
Tore N. Pham
(Division Sign-Off)
Division of Reproductive. Abdomina and Radiological Devi 510(k) Number
§ 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).