(101 days)
CL-S301 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.
21.3 inch Color LCD Monitor
1536 x 2048 (portrait)
High-luminance 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 and the color mura correction functions will help achieve uniformity on the whole screen.
The provided FDA 510(k) summary is for a medical monitor (3MP Color LCD Monitor CL-S301), not an AI device. Therefore, much of the requested information regarding AI device acceptance criteria, study design, and performance metrics (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of a display hardware.
However, I can extract the acceptance criteria and performance data related to the physical characteristics of the monitor, as well as general information about its intended use and comparison to a predicate device.
Here's the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents performance "test items in the guidance" which serve as acceptance criteria for a medical display monitor. The "test method(s)" column describes how these criteria are verified. The conclusion states that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device." This implicitly means the device met the acceptance criteria for each test.
| Performance test items in the guidance | Test method(s) (Implicitly indicating criteria met) |
|---|---|
| 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. |
| 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. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES |
| 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. |
| e. Luminance (maximum, minimum, achievable, and recommended) | Lmin and Lmax on the calibrated luminance are confirmed. |
| 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. |
| g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| h. Luminance uniformity or Mura test (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| i. Stability of luminance and chromaticity response with temperature and time of operation or on-time (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| j. Spatial noise (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| k. Reflection coefficient (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| l. Veiling glare or small-spot contrast (For mammography displays) | N/A (Not applicable as this device is not for digital mammography) |
| 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. |
| n. Gray tracking (gray shades and white point) | AAPM-TG196 Gray Tracking; IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale chromaticity evaluation. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to a physical display device. The tests are performed on the device itself, not on
a "data set" in the context of an AI algorithm. The device manufacturer is JVCKENWOOD Corporation, located in Japan.
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)
This is not applicable. The "ground truth" for a monitor's performance is based on physical measurements and adherence to technical standards (e.g., ISO, IDMS, AAPM-TG directives), not expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for evaluating expert performance on diagnostic tasks, not for physical device testing.
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
This is not applicable. An MRMC study is used to evaluate the diagnostic performance of a system (often AI-assisted) with human readers. This document describes a monitor, which is a display hardware, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the monitor's performance is defined by adherence to established technical standards and measurement protocols (e.g., ISO 13406-2, IDMS 1.03, AAPM-TG18/196, IEC 62563-1).
8. The sample size for the training set
This is not applicable. The device is a physical monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Jvckenwood Corporation Takayuki Kasahara Manager 3-12 Moriya-cho, Kanagawa-ku, Yokohama-shi Yokohama, Kanagawa 221-0022 Japan
Re: K241105
August 1, 2024
Trade/Device Name: 3MP Color LCD Monitor (CL-S301) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: July 5, 2024 Received: July 5, 2024
Dear Takayuki Kasahara:
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.
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).
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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.
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-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 Lamb
Jessica Lamb. Ph.D. Assistant Director DHT8B: Division of Radiological 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)
Device Name
3MP Color LCD Monitor (CL-S301)
Indications for Use (Describe)
CL-S301 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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510(k) SUMMARY
| Submitted Information: | JVCKENWOOD Corporation3-12, Moriya-cho, Kanagawa-ku,Yokohama-shi, Kanagawa, 221-0022 Japan |
|---|---|
| Contact Person: | Takayuki Kasahara, ManagerEmail: kasahara.takayuki@jvckenwood.comTel: +81-45-450-2715Fax: +81-45-450-1926 |
| Date Prepared: | August 1, 2024 |
| Device Name: | 3MP Color LCD Monitor CL-S301 |
| Common Name: | display, diagnostic radiology |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050Medical Image Management and Processing System |
| Product Code: | PGY |
| Predicate Device: | 21.3 inch Color LCD Monitor CL-S300(CL-S300 / K173434) |
| Device Description: | 21.3 inch Color LCD Monitor1536 x 2048 (portrait)High-luminance color LCD panel, which has wide view angle, isused for this product. It is designed for medical image display. Luminance stabilization function composed with luminancesensor and luminance control circuit always observes theluminance and makes it stable. Images are faithfully displayed along grayscale characteristics(DICOM GSDF) based on the calibrated data stored to the lookuptable of the monitor. Luminance and the color mura correction functions will helpachieve uniformity on the whole screen. |
| Intended Use: | CL-S301 is intended to be used in displaying and viewing medicalimages for diagnosis by trained medical practitioners or certifiedpersonnel. It is not meant to be used in digital mammography. |
| Cybersecurity: | FDA guidance located athttps://www.fda.gov/media/119933/download, is followed forcybersecurity concerns. |
| Substantial Equivalence: | CL-S301 shares the same technical characteristics, application,and intended use as our predicate device CL-S300. |
JVCKENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022, Japan Tel +81-45-450-2715
JVCKENWOOD
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(CL-S300 / K173434)
JVCKENWOOD Corporation 3-12, Moriya cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022, Japan
Tel +81-45-450-2715
JVCKENWOOD
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Device Description & Substantial Equivalence Comparison
| Predicate deviceLCD Monitor CL-S300 | Proposed deviceLCD Monitor CL-S301 | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K173434 | K241105 | - |
| Indication for use | CL-S300 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel. It is not meant to beused in digital mammography | CL-S301 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel. It is not meant to beused in digital mammography. | - |
| Display Technology | IPS LCD panel with TFT active-matrixarray with LED backlight | IPS LCD panel with TFT active-matrixarray with LED backlight | - |
| Screen size | Diagonal: 21.3Aspect ratio: 4:3 | Diagonal: 21.3Aspect ratio: 4:3 | - |
| Backlight type | LED | LED | - |
| Frame rate and refreshrate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 3MP (2048 x 1536) | 3MP (2048 × 1536) | - |
| Pixel Pitch | Horizontal: 0.2115 mmVertical: 0.2115 mm | Horizontal: 0.2115 mmVertical: 0.2115 mm | - |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 38.7% | 57.1% | The diagnostic performance is equivalentto that of the predicate devices, though theaperture ratio is higher. |
| Subpixel driving (spatialand temporal dithering) | N/A | N/A | - |
| Display Interface | Input:DVI-D x1DisplayPort x1Output:DisplayPort x1 | Input:DisplayPort x2USB-C x1Output:DisplayPort x1 | The proposed device is not equipped witha DVI-D input, but this is not a problemsince graphics cards are no longerequipped with a DIV-D output. |
| Video bandwidth | Dot clock: 216 MHz | Dot clock: 216 MHz | - |
| Predicate deviceLCD Monitor CL-S300 | Proposed deviceLCD Monitor CL-S301 | Explanation ofDifferences | |
| User controls | DICOM CONFORMANCE TESTCONFIGURATIONINPUT SOURCEDYNAMIC GAMMAAUTO TEXT MODEFUNCTONEDIDTEST PATTERNFACTORY PRESETUSB POWERINPUT SOURCE AUTO SCANNINGHUMAN SENSORDISPLAYPORT | DICOM CONFORMANCE TESTCONFIGURATIONINPUT SOURCEDYNAMIC GAMMAAUTO TEXT MODEFUNCTIONEDIDTEST PATTERNFACTORY PRESETUSB POWERMULTI PIXEL ENHANCERTURBO LUMINANCECOLOR MODEUSB UP-PORT INPUT SELECTUSB-C DATA SETTINGSELF CALIBRATION RESULTDISPLYPORT VERSIONRECOMMENDED REPLACE TIMINGVISUAL POINT MODE | The performance of the proposed device isthe same as the predicate device, thoughsome user controls were added orremoved. |
| Ambient light sensing | Built-in Sensor (For correction duringcalibration) | Built-in Sensor (For correction duringcalibration) | – |
| Touch-screentechnology | N/A | N/A | – |
| Luminance calibrationtools / Quality-controlprocedures | Hardware:Integrated sensorExternal sensorSoftware:QA Medivisor / Medivisor NXFCAL | Hardware:Integrated sensorExternal sensorSoftware:QA Medivisor Agent | – |
| AdditionalSoftware/Firmware | N/A | N/A | – |
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Physical Laboratory Tests
| Performance test items in the guidance | Test method(s) |
|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital cameraequipped with a macro lens. The MTF is calculated with thecaptured data. |
| b. Pixel defects (maximum counts, alloweddefect types, 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 bythepanelmanufacturer. |
| e. Luminance(maximum, minimum, achievable,andrecommended) | Lmin and Lmax on the calibrated luminance are confirmed. |
| f.Conformancetoagrayscale-to-luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance ResponseLuminance response for 256 levels are measured. |
| (For mammography displays)g. Luminance at 30° and 45° in diagonal,horizontal, and vertical directions at centerand four corners | N/A |
| (For mammography displays)h. Luminance uniformity or Mura test | N/A |
| (For mammography displays)i. Stability of luminance and chromaticityresponse with temperature and time ofoperation or on-time | N/A |
| (For mammography displays)j. Spatial noise | N/A |
| (For mammography displays)k. Reflection coefficient | N/A |
| (For mammography displays)I. Veiling glare or small-spot contrast | N/A |
| (For color displays)m. Color tracking (primary colors and colorgamut) | 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 shades and whitepoint) | AAPM-TG196 Gray TrackingIEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscalechromaticity evaluation |
Conclusion
As shown above, the intended use of the subject and predicate devices are identical, the technical characteristics are similar, and any differences between the characteristics do not affect the device safety or effectiveness. The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed 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).