(51 days)
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
RadiForce RX570 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. There are two model variations, RX570 and RX570-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX570 is Anti-Glare (AG) treatment and that of the RX570-AR is Anti-Reflection (AR) coating. Two RX570 monitors mounted on a single stand configuration is available identified by with "MD" like RX570-MD and RX570-AR-MD. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX570. RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX70 and it's not a medical imaging software.
The provided document describes the EIZO RadiForce RX570; RadiForce RX570-AR medical display monitor and its substantial equivalence to predicate devices, the RadiForce RX560 and RadiForce GX540. It evaluates the device based on performance testing against predefined criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The bench tests below were performed on the RadiForce RX570 following the instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology' issued on September 28, 2022" and that "the display characteristics of the RadiForce RX570 meet the pre-defined criteria when criteria are set." However, it does not provide a specific table directly listing the acceptance criteria values alongside the measured device performance values.
Instead, it lists the types of measurements performed and provides a general statement about meeting predetermined criteria and equivalence to predicate devices. For example, for DICOM GSDF conformance, it states "Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)," implying that the device met the DICOM GSDF conformance criteria.
Therefore, a table cannot be fully generated with specific numeric acceptance criteria and performance data from the provided text. The document acts as a high-level summary of the testing performed and the conclusion reached.
For a comprehensive table, access to the full test report would be needed. Based on the general statements, the interpretation is that the device did meet the criteria for each test:
| Acceptance Criteria Category/Test | Reported Device Performance |
|---|---|
| Spatial Resolution (MTF) | Met pre-defined criteria; equivalent to predicate device. |
| Pixel Defects/Faults | Met pre-defined criteria. |
| Miscellaneous Artifacts | No artifacts observed; met pre-defined criteria. |
| Temporal Response | Met pre-defined criteria; equivalent to predicate device. |
| Luminance | Met pre-defined criteria; equivalent to predicate device. |
| DICOM GSDF Conformance | Conformed to DICOM GSDF as specified in AAPM TG18. |
| Angular Dependency of Luminance | Met pre-defined criteria; equivalent to predicate device. |
| Luminance Non-uniformity | Met pre-defined criteria as specified in TG18 guideline. |
| Chromaticity Non-uniformity | Met pre-defined criteria as specified in TG18 guideline. |
| Luminance Stability | Met pre-defined criteria. |
| Noise (NPS) | Met pre-defined criteria. |
| Display Reflections (specular, diffuse, haze) | Met pre-defined criteria. |
| Small-Spot Contrast Ratio | Met pre-defined criteria. |
| Color Tracking and Gray Tracking | Met pre-defined criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for the test set in terms of number of devices or datasets. The testing appears to have been performed on the RadiForce RX570 device itself to assess its physical and technical characteristics.
The testing methods are described as "bench tests" performed "following the instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology'." This indicates the data provenance is from prospective bench testing conducted in a lab environment. There is no information about the country of origin of the data beyond the manufacturer being EIZO Corporation of Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The device is a medical display monitor, not an AI or diagnostic software that requires human expert review to establish ground truth for performance evaluation in medical image interpretation. The "ground truth" for this device's performance is established by objective physical measurements based on industry standards and FDA guidance.
4. Adjudication Method for the Test Set
This information is not applicable. Since the performance evaluation relies on objective physical measurements and conformance to technical standards (e.g., DICOM GSDF, TG18 guidelines), there is no need for an adjudication method involving multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic AI systems or CADe/CADx devices to evaluate their impact on human reader performance. The RadiForce RX570 is a display monitor, and its performance is evaluated by its technical specifications and adherence to display standards, not by its effect on human readers' diagnostic accuracy.
6. Standalone Performance
A standalone performance evaluation was done. The entire Section 7, "Performance Testing," describes the standalone (algorithm-only, or in this case, device-only) performance testing of the RadiForce RX570. The device's characteristics (e.g., resolution, luminance, DICOM conformance) were measured directly against established technical guidelines and standards.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily based on technical standards, physical measurements, and industry guidelines. Specifically, the document mentions:
- "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology"
- "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)"
- "DICOM GSDF" (Grayscale Standard Display Function)
8. Sample Size for the Training Set
This information is not applicable. The RadiForce RX570 is a physical display device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a display monitor.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
EIZO Corporation Hiroaki Hashimoto Senior Manager of Regulatory Compliance and Safety Department 153 Shimokashiwano Hakusan, Ishikawa 924-8566 Japan
Re: K243221
November 27, 2024
Trade/Device Name: RadiForce RX570; RadiForce RX570-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: October 7, 2024 Received: October 7, 2024
Dear Hiroaki 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K243221
Device Name
RadiForce RX570; RadiForce RX570-AR
Indications for Use (Describe)
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for EIZO. The logo consists of a stylized square made up of smaller squares in a checkerboard pattern, with a jagged edge on the top and a stepped edge on the bottom. To the right of the square is the word "EIZO" in bold, sans-serif font, with a registered trademark symbol next to the "O".
| EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa924-8566 Japan | NameDepartment | Hiroaki HashimotoRegulatory Compliance andSafety |
|---|---|---|
| U.S. Food and Drug AdministrationCenter for Devices and Radiological Health | Telephone | +81 (76) 274-2468 |
| hiroaki.hashimoto@eizo.com |
510(k) Summary
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Contact Person: Hiroaki Hashimoto Date of Prepared: October 7th, 2024
2. Device
- . Name of Device: RadiForce RX570; RadiForce RX570-AR
- Common or Usual Name: 21.3 inch (54.1 cm) Color LCD Monitor ●
- . Classification Name: Medical Image Management and Processing System (21 CFR 892.2050)
- Regulatory Class: . II
- PGY ● Product Code:
3. Predicate Device
| • Name of Device: | RadiForce RX560, RX560-AR (K172738) |
|---|---|
| • Common or Usual Name: | 54.1 cm (21.3 inch) class Color LCD Monitor |
| • Classification Name: | Medical Image Management and Processing System(21 CFR 892.2050) |
| • Regulatory Class: | II |
| • Product Code: | PGY |
| • Name of Device: | RadiForce GX540 (K151883) |
| • Common or Usual Name: | 5MP Monochrome LCD Monitor |
| • Classification Name: | Medical Image Management and Processing System(21 CFR 892.2050) |
| • Regulatory Class: | II |
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4. Device Description
RadiForce RX570 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
There are two model variations, RX570 and RX570-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX570 is Anti-Glare (AG) treatment and that of the RX570-AR is Anti-Reflection (AR) coating.
Two RX570 monitors mounted on a single stand configuration is available identified by with "MD" like RX570-MD and RX570-AR-MD.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX570.
RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX570 and it's not a medical imaging software.
5. Indications for use
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
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6. Comparison of Technological Characteristics with the predicate device
The comparison table below enumerates information derived from the product brochure and measured values of the each device and different technological characteristics are discussed in it:
| Attributes | Proposed Device:RadiForce RX570 | Predicate Device:RadiForce RX560 |
|---|---|---|
| Indications for Use | This product is intended for usein clinical radiological images(including full-field digitalmammography and digitalbreast tomosynthesis) forreview, analysis, and diagnosisby trained medicalpractitioners. | This product is intended to beused in displaying and viewingdigital images, includingstandard and multiframe digitalmammography, for review,analysis and diagnosis bytrained medical practitioners. Itis specially designed for breasttomosynthesis applications. |
| Display Technology | TFT ColorLCD Panel (IPS) | TFT ColorLCD Panel (IPS) |
| Screen size | 54.1cm / 21.3"Aspect ratio: 4 : 5 | 54.1cm / 21.3"Aspect ratio: 4 : 5 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | ||
| Digital Scanning Frequency(H / V) | 31 - 135 kHz / 23 - 61 HzFrame synchronous mode: 23.5- 25.5 Hz, 47 - 51 Hz | 31 - 135 kHz / 23 - 61 HzFrame synchronous mode: 23.5- 25.5 Hz, 47 - 51 Hz |
| Pixel pitch | ||
| Pixel pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm |
| Subpixel pattern | RGB Vertical Stripe | RGB Vertical Stripe |
| Pixel aperture ratio | 0.627 | 0.656 |
| Subpixel driving (spatial and temporal dithering) | ||
| Independent Subpixel drive | N/A | N/A |
| Dithering | 3bit FRC | 3bit FRC |
| Display Interface | ||
| Input video signals | DVI-D (dual link) x 1,DisplayPort x 2 | DVI-D (dual link) x 1,DisplayPort x 1 |
| Output video signals | DisplayPort x 1 (daisy chain) | DisplayPort x 1 (daisy chain) |
| Video bandwidth | DVI : 25-290MHzDisplayPort : 25-290MHz | DVI: 290MHzDisplayPort: 290MHz |
| User controls | ||
| OSD | CAL Switch / FineContrast /Color Mode | CAL Switch / FineContrast /Color Mode |
| Mode Skip | Mode Skip | |
| Hybrid Gamma PXL | Hybrid Gamma PXL | |
| Brightness | Brightness | |
| Contrast | Contrast | |
| Temperature | Temperature | |
| Gamma | Gamma | |
| Hue | Hue | |
| Saturation | Saturation | |
| Gain | Gain | |
| SelfQC | SelfQC | |
| Sharpness Recovery | Picture Expansion | |
| DP Daisy Chain | Sharpness Recovery | |
| PinP | DP Daisy Chain | |
| Orientation(H/W Pivot) | Orientation (H/W Pivot) | |
| Power Save | Power Save | |
| DP Power Save | DP Power Save | |
| Language | EcoView Sense | |
| OSD Information | Language | |
| Indicator | OSD Information | |
| Input Selection | Indicator | |
| Key Lock | Input Selection | |
| LEA(Life Expectancy Analyzer) | Logo | |
| USB Selection for KVMSwitch | Key Lock | |
| Grayscale Warning | LEA(Life Expectancy Analyzer) | |
| DDC for Medical | ||
| Grayscale Warning | ||
| RadiCS | Complete QC Tests | Complete QC Tests |
| Calibration | Calibration | |
| Task Setting | Task Setting | |
| History Management | History Management | |
| Asset Management | Asset Management | |
| Ambient light sensing | ||
| Ambient light sensor | Photo DiodePosition: In the upper right bezel of the screenSoftware tool: RadiCS | Photo DiodePosition: In the upper right bezel of the screenSoftware tool: RadiCS |
| Touch-screen technology | ||
| N/A | N/A | |
| Luminance calibration tools | ||
| Integrated optical sensorExternal optical sensorCalibration software:RadiCS | Integrated optical sensorExternal optical sensorCalibration software:RadiCS | |
| Quality-control procedures | ||
| Software: RadiCSAAPM On-line Report No.03:2005 compliant | Software: RadiCSAAPM On-line Report No.03:2005 compliant | |
| Software/Firmware | ||
| N/A | N/A |
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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX570.
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7. Performance Testing
The bench tests below were performed on the RadiForce RX570 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28, 2022:
- Measurement of spatial resolution expressed as modulation transfer function (MTF) ●
- The maximum number allowed for each type of pixel defects/faults ●
- . Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- Measurement of temporal response
- Measurement of Luminance ●
- Verification of the conformance to DICOM GSDF as specified in Assessment of . Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- . Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen ● as specified in TG18 guideline
- . Performance data on luminance stability
- Measurement of noise expressed as noise power spectrum (NPS) .
- Measurement of display reflections including specular, diffuse and haze components
- Measurement of small-spot contrast ratio ●
- Measurement of Color tracking and Gray tracking
The test results showed that the RadiForce RX570 has display characteristics equivalent to those of the predicate device, RadiForce RX560 or RadiForce GX540.
Besides, the display characteristics of the RadiForce RX570 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX570.
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8. Conclusion
The RadiForce RX570 was determined to be substantially equivalent to the predicate device due to the following reasons:
- The stated intended use is substantially the same as that of the predicate device. .
- It was confirmed that the technological characteristics differences from those of the . predicate device do not affect the safety or the effectiveness.
- . The bench tests demonstrated that the display characteristics are equivalent to those of the predicate device.
§ 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).