(90 days)
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital mammography.
32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)
- Color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance mura correction functions will help achieve uniformity on the whole screen.
The provided text describes a 510(k) summary for the JVCKENWOOD 8MP Color LCD Monitor CL-R813. It is a submission for a display device, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and specific ground truth types like pathology or outcomes data) are not applicable to this document.
However, I can extract information regarding the device's technical performance and the tests conducted to demonstrate its characteristics.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance test items from the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" and the methods used. It states that the CL-R813 met "predefined criteria" but does not explicitly provide a table of acceptance criteria with numerical thresholds nor does it report specific numerical performance results for the CL-R813 against those criteria. It only states a qualitative finding of equivalence.
| Performance Test Item | Test Method(s) | Reported Device Performance |
|---|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital camera equipped with a macro lens. The MTF is calculated with the captured data. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| b. Pixel defects (maximum counts, allowed defect types, and locations) | ISO 13406-2; IDMS 1.03, 7.6 DEFECTIVE PIXELS. Pixel defects are counted based on the ISO13406-2, 3.4.13 table 3. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME. Rise and fall time constants at four grayscale intervals (0-100%, 5-95%, 10-90%, 40-60%) are provided by the panel manufacturer. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| e. Luminance (maximum, minimum, achievable, and recommended) | Lmin and Lmax on the calibrated luminance are confirmed. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| f. Conformance to a grayscale to luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response. Luminance response for 256 levels are measured. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| (For color displays) m. Color tracking (primary colors and color gamut) | Color scale: IDMS 1.03, 6. Gray- and Color-Scale Measurement & IDMS 1.03, 5.4 Color-Signal White. Color gamut volume: IDMS 1.03, 5.31 Volume-Color-Reproduction Capability. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
| (For color displays) n. Gray tracking (gray shades and white point) | AAPM-TG196 Gray Tracking; IEC 62563-1: 2009+AMD1:2016+AMD2:2021, 7.4.9 Greyscale chromaticity evaluation. | Confirmed equivalent display characteristics to predicate device. Meets predefined criteria. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a display device, not an AI/ML algorithm that processes a "test set" of medical images from patients. The testing involved evaluating the physical characteristics of the monitor hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for an AI/ML algorithm is not relevant for a display hardware submission.
4. Adjudication method 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 is a display device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable. For a display device, the "ground truth" is typically defined by industry standards and objective physical measurements (e.g., spectral characteristics of light, spatial resolution patterns). The document references standards like ISO, IDMS, AAPM-TG18, and IEC.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
JVCKENWOOD Corporation Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 Japan
December 21, 2022
Re: K222864
Trade/Device Name: 8MP Color LCD Monitor CL-R813 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: December 14, 2022 Received: December 15, 2022
Dear Hideki Tengeiji:
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. 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 located 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.
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
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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 Low
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222864
Device Name 8MP Color LCD Monitor CL-R813
Indications for Use (Describe)
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital mammography.
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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K222864
510(k) SUMMARY
I. Submitter
| Submitter: | JVCKENWOOD Corporation |
|---|---|
| 3-12, Moriya-cho, Kanagawa-ku, | |
| Yokohama-shi, Kanagawa, 221-0022 Japan | |
| Contact Person: | Hideki Tengeiji, Senior Manager |
| Email: tengeiji.hideki@jvckenwood.com | |
| Tel: +81-45-450-2715 | |
| Fax: +81-45-450-1926 | |
| Date Prepared: | September 22, 2022 |
II. Device
| Name of Device: | 8MP Color LCD Monitor CL-R813 |
|---|---|
| Common or Usual Name: | Display, diagnostic radiology |
| Classification Name: | Medical Image Management and Processing System(Part 892 Radiology Devices Sec. 892.2050) |
| Regulatory Class | II |
| Product Code | PGY |
III. Predicate Device
| Name of Device: | 21.3 inch (54.0cm) Color LCD Monitor CL-R211 (K182539) |
|---|---|
| Common or Usual Name: | Display, diagnostic radiology |
| Classification Name: | Medical Image Management and Processing System(Part 892 Radiology Devices Sec. 892.2050) |
| Regulatory Class | II |
| Product Code | PGY |
JVCKENWOOD
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IV. Device Description
32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)
- Color LCD panel, which has wide view angle, is used for this product. It is designed for ■ medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance mura correction functions will help achieve uniformity on the whole screen.
V. Indications for use
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
VI. Cybersecurity
FDA quidance located at https://www.fda.gov/media/86174/download, is followed for cybersecurity concerns.
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VII. Comparison of Technological Characteristics with the predicate device
The comparison table below list information obtained from the product catalogs and measurements and different technological characteristics are discussed in it.
| Predicate deviceLCD Monitor CL-R211 | Proposed deviceLCD Monitor CL-R813 | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K182539 | - | - |
| Indication for use | CL-R211 is intended to beused in displaying and viewingmedical images for diagnosisby trained medicalpractitioners or certifiedpersonnel. It is not meant tobe used in digitalmammography. | CL-R813 is intended to beused in displaying andviewing medical images fordiagnosis by trained medicalpractitioners or certifiedpersonnel. It is not meant tobe used in digitalmammography. | - |
| Display Technology | IPS LCD panel with TFTactive-matrix array with LEDbacklight | IPS LCD panel with TFTactive-matrix array with LEDbacklight | - |
| Screen size | Diagonal: 21.3"Aspect ratio: 4:3 | Diagonal: 32"Aspect ratio: 16:9 | The display area of theproposed device is largerthan that of the predicatedevice. |
| Backlight type | LED | LED | - |
| Frame rate and refresh rate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 2MP (1200 x 1600) | 8MP (3840 × 2160) | The resolution of theproposed device is higherthan that of the predicatedevice. |
| Pixel Pitch | Horizontal: 0.270mmVertical: 0.270mm | Horizontal: 0.1845mmVertical: 0.1845mm | Pixel pitch of theproposed device aresmaller than those of thepredicate device. |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 57 % | 57 % | - |
| Subpixel driving (spatial andtemporal dithering) | N/A | N/A | - |
| Display Interface | Input: DVI-D x1DisplayPort x1Output: DisplayPort x1 | Input: DVI-D x1DisplayPort x2Output: DisplayPort x1 | - |
| Video bandwidth | Dot clock: 162 MHz | Dot clock: 533.25 MHz | So the resolution of theproposed device is higherthan that of the predicatedevice, the dot clock ofthe proposed device ishigher than that of thepredicate device |
| User control | DICOM CONFORMANCE TESTConfiguration switchInput signal switchDynamic gammaAUTO TEXTHuman presence sensorEDID switchTest patternUSB Power | Config SelectBacklightContrastSource SelectHuman Sensor | Although the usercontrols are different, theperformance of theproposed device is thesame as the predicatedevice. |
| Ambient light sensing | Built-in Sensor (For correctionduring calibration) | Built-in Sensor (Forcorrection during calibration) | - |
| Touch-screen technology | N/A | N/A | - |
| Luminance calibration tools /Quality-control procedures | Hardware:Integrated sensorExternal sensorSoftware:QA Medivisor/Medivisor NXFCAL | Hardware:Integrated sensorExternal sensorSoftware:QA Medivisor AgentFCAL | - |
| Additional Software/Firmware | N/A | N/A | - |
The above differences in technical characteristics do not affect the safety and the effectiveness of the CL-R813.
JVCKE OD
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VIII. Performance Test
The following performance tests were performed on the CL-R813 in accordance with the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017.
| Performance test itemsin the guidance | Test method(s) |
|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digitalcamera equipped with a macro lens. The MTF is calculatedwith the captured data. |
| b. Pixel defects (maximumcounts, allowed defecttypes, and locations) | ISO 13406-2IDMS 1.03, 7.6 DEFECTIVE PIXELSPixel defects are counted based on the ISO13406-2, 3.4.13table 3. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous TestsIDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIMERise and fall time constants at four grayscale intervals (0-100%, 5-95%, 10-90%, 40-60%) are provided by thepanel manufacturer. |
| e. Luminance (maximum,minimum, achievable, andrecommended | Lmin and Lmax on the calibrated luminance are confirmed. |
| f. Conformance to a grayscaleto luminance function (e.g.,DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance ResponseLuminance response for 256 levels are measured. |
| (For color displays)m. Color tracking (primarycolors and color gamut) | Color scale:IDMS 1.03, 6. Gray- and Color-Scale MeasurementIDMS 1.03, 5.4 Color-Signal WhiteColor gamut volume:IDMS 1.03, 5.31 Volume-Color-Reproduction Capability |
| (For color displays)n. Gray tracking (gray shadesand white point) | AAPM-TG196 Gray TrackingIEC 62563-1: 2009+AMD1:2016+AMD2:2021, 7.4.9Greyscale chromaticity evaluation |
As a result of the performance test, it was confirmed that the CL-R813 has the equivalent display characteristics as the predicate device, CL-R211. The display characteristics of the CL-R813 meet the predefined criteria.
The CL-R813 has not been tested on animal or clinical testing.
IX. Conclusions
As shown above, the intended use of the subject device and the predicate device is identical, the technical characteristics are similar, and any differences in the characteristics do not affect the safety or effectiveness of the device. The results of the performance testing and the verification and validation demonstrate that the subject device is substantially equivalent to the predicate device currently on the market.
§ 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).