(190 days)
CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
30.9 inch Color Digital Mammography LCD Monitor 4200 x 2800 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display including mammography.
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.
A glass filter protects the surface of the LCD panel.
The provided document is a 510(k) premarket notification for a medical display monitor (JVCKENWOOD 12MP Color Digital Mammography LCD Monitor CL-S1200). It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
However, the document does NOT contain information about a study proving the device meets clinical acceptance criteria related to AI performance, human reader improvement with AI, or standalone AI performance.
The "acceptance criteria" discussed in the document are limited to physical laboratory tests for display monitor performance (e.g., spatial resolution, pixel defects, luminance, color tracking). These tests are conducted on the device itself (the monitor), not on an AI algorithm that processes medical images.
Therefore, I cannot fulfill all parts of your request because the provided text does not contain the necessary information regarding:
- A table of acceptance criteria for AI performance and reported device performance for AI.
- Sample size used for the test set and data provenance for AI testing.
- Number of experts and qualifications for establishing ground truth for AI testing.
- Adjudication method for AI test set.
- MRMC comparative effectiveness study results (effect size of human readers improvement with AI).
- Standalone AI performance results.
- Type of ground truth used for AI testing.
- Sample size for AI training set.
- How ground truth for AI training set was established.
Based on the provided text, the only "acceptance criteria" and "study" information available is for the display monitor's technical performance, not for an AI algorithm's performance.
Here's what can be extracted regarding the display monitor's acceptance criteria and proof of meeting them:
1. Table of Acceptance Criteria and Reported Device Performance (for the Display Monitor):
The document lists various performance test items and the methods used to evaluate them. It implies that the device met these criteria through testing. While specific numerical results are not provided in a table, the Conclusion states: "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 confirms that the device met the performance standards expected for a device deemed substantially equivalent.
| Acceptance Criteria (Performance Test Item) | Test Method(s) | Reported Device Performance (Implicitly Met) |
|---|---|---|
| a. Spatial resolution | MTF calculated from bar pattern display and capture. | Met criteria for substantial equivalence to predicate device. |
| b. Pixel defects (maximum counts, allowed defect types, and locations) | ISO 13406-2, IDMS 1.03, 7.6 DEFECTIVE PIXELS. Pixel defects counted based on ISO13406-2, 3.4.13 table 3. | Met criteria for substantial equivalence to predicate device. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES. | Met criteria for substantial equivalence to predicate device. |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME (Rise and fall time constants). | Met criteria for substantial equivalence to predicate device. |
| e. Luminance (maximum, minimum, achievable, and recommended) | Lmin and Lmax on calibrated luminance confirmed. | Met criteria for substantial equivalence to predicate device. |
| 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 measured. | Met criteria for substantial equivalence to predicate device. |
| g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners (For mammography displays) | AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies. | Met criteria for substantial equivalence to predicate device. |
| h. Luminance uniformity or Mura test (For mammography displays) | AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies. | Met criteria for substantial equivalence to predicate device. |
| i. Stability of luminance and chromaticity response with temperature and time of operation or on-time (For mammography displays) | Temperature: 0 °C, 20 °C, 25 °C, 30 °C, 40 °C. Time: after AC power turned on. | Met criteria for substantial equivalence to predicate device. |
| j. Spatial noise (For mammography displays) | Noise power spectrum calculated from uniform area display and digital camera capture. | Met criteria for substantial equivalence to predicate device. |
| k. Reflection coefficient (For mammography displays) | AAPM-TG18, 4.2 Display Reflection (Specular and Diffuse reflection coefficients measured). | Met criteria for substantial equivalence to predicate device. |
| l. Veiling glare or small-spot contrast (For mammography displays) | AAPM-TG18, 4.7 Veiling Glare. | Met criteria for substantial equivalence to predicate device. |
| m. Color tracking (primary colors and color gamut) (For color displays) | IDMS 1.03, 6. Gray- and Color-Scale Measurement; IDMS 1.03, 5.4 Color-Signal White; IDMS 1.03, 5.31 Volume-Color-Reproduction Capability. | Met criteria for substantial equivalence to predicate device. |
| n. Gray tracking (gray shades and white point) (For color displays) | AAPM-TG196 Gray Tracking; IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale chromaticity evaluation. | Met criteria for substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance (for the Display Monitor):
- Sample Size: This is likely a single device (the JVCKENWOOD 12MP Color Digital Mammography LCD Monitor CL-S1200) that underwent these physical laboratory tests. The concept of a "test set" as in a dataset for AI is not applicable here.
- Data Provenance: The tests are physical laboratory tests conducted by the manufacturer (JVCKENWOOD Corporation) in Japan. The data is prospective, as it's generated specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for the Display Monitor):
- Experts: Not applicable in the context of physical display testing. The ground truth for these tests is based on the physical properties of the display and established objective measurement standards (e.g., ISO, AAPM-TG18, IDMS). Personnel performing the tests would be qualified engineers or technicians.
4. Adjudication method (for the Display Monitor):
- Adjudication Method: Not applicable. These are objective physical measurements per established standards.
5. MRMC comparative effectiveness study results (for the Display Monitor):
- MRMC Study: Not applicable. This document does not describe an MRMC study comparing human reader performance with and without this display monitor, or with AI assistance. It focuses solely on the technical specifications and substantial equivalence of the monitor itself.
6. Standalone (algorithm only without human-in-the loop performance) (for the Display Monitor):
- Standalone Performance: Not applicable. This device is a display monitor, not an AI algorithm.
7. The type of ground truth used (for the Display Monitor):
- Ground Truth: Objective physical measurement standards and industry guidelines (e.g., AAPM-TG18, ISO 13406-2, IDMS 1.03, IEC 62563-1) serve as the "ground truth" or reference for evaluating the display's performance.
8. The sample size for the training set (for the Display Monitor):
- Training Set Sample Size: Not applicable. This device is a hardware product (display monitor), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established (for the Display Monitor):
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for a display monitor.
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June 29, 2021
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JVCKENWOOD Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
Re: K203733
Trade/Device Name: 12MP Color Digital Mammography LCD Monitor CL-S1200 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 21, 2021 Received: May 26, 2021
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 801 medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices
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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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203733
Device Name
12MP Color Digital Mammography LCD Monitor CL-S1200
Indications for Use (Describe)
CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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JVCKENWOOD
510(k) SUMMARY
| Submitted Information: | JVCKENWOOD Corporation3-12, Moriya-cho, Kanagawa-ku,Yokohama-shi, Kanagawa, 221-0022 Japan | ||
|---|---|---|---|
| Contact Person: | Hideki Tengeiji, Senior ManagerEmail: tengeiji.hideki@jvckenwood.comTel: +81-45-450-2715Fax: +81-45-450-1926 | ||
| Date Prepared: | May 21, 2021 | ||
| Device Name: | 12MP Color Digital Mammography LCD Monitor CL-S1200 | ||
| Common Name: | display, diagnostic radiology | ||
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Medical Image Management and Processing System) | ||
| Predicate Device: | 21.3 inch (54cm) Color LCD Monitor CL-S500(CL-S500/ K191137) | ||
| Device Description: | 30.9 inch Color Digital Mammography LCD Monitor4200 x 2800 (landscape)■ High-luminance color LCD panel, which has wide view angle, isused for this product. It is designed for medical image displayincluding mammography.■ Luminance stabilization function composed with luminance sensorand luminance control circuit always observes the luminance andmakes 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.■ A glass filter protects the surface of the LCD panel. |
JVCKENWOOD Corporation
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JVCKENWOOD
| Cybersecurity: | FDA guidance located athttps://www.fda.gov/media/86174/download, are followed forcybersecurity concerns. |
|---|---|
| Intended Use: | CL-S1200 is intended to be used in displaying and viewing medicalimages for diagnosis by trained medical practitioners or certifiedpersonnel.It's intended to be used in digital mammography PACS, digital breasttomosynthesis and modalities including FFDM. |
| stantial Equivalence: | CL-S1200 shares the same technical characteristics application |
- Substantial Equivalence: CL-S1200 shares the same technical characteristics, application, and intended use as our predicate device CL-S500/ K191137.
JVCKENWOOD Corporation
Healthcare Business Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
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Device Description & Substantial Equivalence Comparison
| Predicate device | Proposed device | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | LCD Monitor CL-S500K191137 | LCD Monitor CL-S1200 | — |
| Indication for use | CL-S500 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel.They're intended to be used in digitalmammography PACS, digital breasttomosynthesis and modalities includingFFDM. | CL-S1200 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel.It's intended to be used in digitalmammography PACS, digital breasttomosynthesis and modalities includingFFDM. | — |
| 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: 21.3" (54.1cm)Aspect ratio: 4:5 | Diagonal: 30.9" (78.4cm)Aspect ratio: 3:2 | Half of the screen size of the proposeddevice is the same as the predicatedevice. |
| Backlight type | LED | LED | — |
| Frame rate and refreshrate | Portrait:Horizontal: 129.1KHzVertical: 50HzLandscape:Horizontal: 103.5KHzVertical: 50Hz | Landscape:Horizontal: 170.5 kHzVertical: 60 Hz | Although refresh rate of the proposeddevice is higher than the predicate device,the difference is not distinguishable whenobserving still images. |
| Resolution / Pixel array | 5MP (2048 x 2560) | 12MP (4200 x 2800) | Less than half of the resolution of theproposed device is the same as thepredicate device. |
| Pixel Pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.1554mmVertical: 0.1554mm | Pixel pitch of the proposed device is equalto smaller than that of the predicateddevice. |
| Subpixel pattern | Stripe RGB | Stripe RGB | — |
| Pixel aperture ratio | 53.00% | 56.50% | Almost the same. |
| Subpixel driving (spatialand temporal dithering) | N/A | N/A | — |
| Display Interface | Input:DVI-D x1DisplayPort x1Output:DisplayPort x1 | Input:DisplayPort x2Output: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: 285 MHz | Dot clock: 746 MHz | Since the resolution and refresh rate arehigher than the predicate device, the dotclock of the proposed device is higher. |
| User controls | Input signal switchDynamic gammaAUTO TEXTConfiguration switch,DisplayPort Power,USB Power | Input signal switchDynamic gammaAUTO TEXTEDID switchConfiguration switchDisplayPort PowerUSB PowerPixel EnhancerTurbo LuminanceDynamic Range ExtensionAuto Config Select | The functions in the predicate device arealso available in the proposed device. |
| 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 AgentFCAL | – |
| 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 by the panelmanufacturer. |
| e. Luminance(maximum, minimum, achievable, andrecommended) | 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 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 | AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies |
| (For mammography displays)h. Luminance uniformity or Mura test | AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies |
| (For mammography displays)i. Stability of luminance and chromaticityresponse with temperature and time ofoperation or on-time | Temperature:Luminance and chromaticity response in 0 °C, 20 °C, 25 °C,30 °C, and 40 °CTime:Luminance and chromaticity are measured after the AC powerof the display is turned on. |
| (For mammography displays)j. Spatial noise | The uniform area including the two lines is displayed andcaptured by a digital camera equipped with a macro lens. Thenoise power spectrum is calculated with the captured data. |
| (For mammography displays)k. Reflection coefficient | AAPM-TG18, 4.2 Display ReflectionSpecular and Diffuse reflection coefficients are measured. |
| (For mammography displays)I. Veiling glare or small-spot contrast | AAPM-TG18, 4.7 Veiling Glare |
| (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).