(30 days)
MS-S300 is intended to be used in displaying 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.
21.3 inch Monochrome Digital Mammography LCD Monitor
2048 x 1536 (landscape), 1536 x 2048 (portrait)
■ High-luminance monochrome 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.
■ It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
■ Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
The provided text describes the 510(k) premarket notification for the JVCKENWOOD 3MP Monochrome Digital Mammography LCD Monitor MS-S300. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific clinical acceptance criteria.
However, based on the Substantial Equivalence Comparison table and Recommended Physical Laboratory Tests, we can infer some performance aspects and acceptance criteria for the display itself.
1. Table of acceptance criteria and the reported device performance:
Since this is a medical display, the "acceptance criteria" largely revolve around meeting or exceeding the technical specifications of the predicate device and adhering to recognized industry standards for medical displays (like AAPM-TG18 and DICOM GSDF). The "reported device performance" is essentially its technical specifications and how they compare to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (MS-S300) |
|---|---|
| Resolution/Matrix Size: 3MP (1536 x 2048) | 3MP (1536 x 2048) |
| Screen Technology: TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) |
| Backlighting: LED | LED |
| DICOM Calibrated Luminance: 500cd/m² | 500cd/m² (As per DICOM GSDF conformance and Luminance Response test of AAPM-TG18) |
| Grayscale Tones: At least 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) |
| Non-Uniformity Compensation: Digital Uniformity Correction System | Digital Uniformity Correction System |
| Spatial Resolution: MTF measurement using bar-pattern image | MTF measurement method that uses a bar-pattern image. (Rectangle chart method) |
| Pixel Defects: Conformance to ISO13406-2 and VESA 2001 | ISO13406-2 and Flat Panel Display Measurement Standard [VESA 2001] were used. |
| Artifacts: Absence of phase/clock, ringing, ghosting, image sticking | Artifacts (phase or clock, ringing, ghosting, image sticking, etc.) were checked. (Implies absence or within acceptable limits) |
| Luminance Stability: Across temperature and time of operation | Luminance response tested at 0°C, 25°C, and 40°C by AAPM-TG18. (Power On Drift monitored) |
| Conformance to grayscale-to-luminance function: DICOM GSDF | Luminance Response at 256 digital values by AAPM-TG18. (Implies conformance to DICOM GSDF) |
| Luminance Uniformity: As per AAPM-TG18 | Luminance Uniformity by AAPM-TG18. Chromaticity by AAPM-TG18. (Implies meeting AAPM-TG18 criteria) |
| Veiling Glare/Small-Spot Contrast: As per AAPM-TG18 | Veiling Glare test by AAPM-TG18. (Implies meeting AAPM-TG18 criteria) |
| Response Time: Better than predicate (40ms) | 28ms (On/Off) |
| Maximum Luminance: Better than predicate (1700cd/m²) | Typ. 2000cd/m² |
| Viewing Angle: Wider than predicate (CR>10, H/V 176°) | CR>10 Horizontal: Typ.178 Vertical: Typ.178 |
| Contrast Ratio: Wider than predicate (Typ. 1400:1) | Typ. 1500:1 |
2. Sample size used for the test set and the data provenance:
The document describes a technical evaluation of a medical display monitor, not a clinical study on medical images. Therefore, "test set" and "data provenance" in the context of clinical images are not applicable here. The testing involves the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not explicitly provided. The tests described are objective physical and photometric measurements conducted on the display device, likely by engineers or technicians using specialized equipment and conforming to established standards (e.g., AAPM-TG18, ISO13406-2). There is no mention of human experts establishing "ground truth" for these technical performance metrics.
4. Adjudication method for the test set:
Not applicable in the sense of clinical image review. The evaluation methods are technical measurements against objective criteria and standards.
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 device is a display monitor, not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used:
For the technical performance of the monitor, the "ground truth" is defined by the objective measurement standards and physical properties specified in documents like AAPM-TG18, ISO13406-2, VESA 2001, and the DICOM GSDF standard. For example, "Luminance Response at 256 digital values by AAPM-TG18" means the measured luminance values at those digital inputs are compared against the expected values defined by the AAPM-TG18 guideline (which aligns with DICOM GSDF).
8. The sample size for the training set:
Not applicable, as this is a physical medical display monitor, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical display monitor, not a machine learning model.
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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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 21, 2020
JVCKENWOOD Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN
Re: K200161
Trade/Device Name: 3MP Monochrome Digital Mammography LCD Monitor MS-S300 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 16, 2020 Received: January 22, 2020
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
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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 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 (OS) 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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
3MP Monochrome Digital Mammography LCD Monitor MS-S300
Indications for Use (Describe)
MS-S300 is intended to be used in displaying 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.
| 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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JVCKENWOOD
510(k) SUMMARY K200161
| 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: | January 16, 2020 | |
| Device Name: | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | |
| Common Name: | MS-S300 (MS-S300xxxxx) | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 21.3 inch (54cm) Monochrome LCD Monitor MS35i2(MS35i2/ K133686) | |
| Device Description: | 21.3 inch Monochrome Digital Mammography LCD Monitor2048 x 1536 (landscape), 1536 x 2048 (portrait)■ High-luminance monochrome LCD panel, which has wide viewangle, is used for this product. It is designed for medical imagedisplay.■ 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.■ It minimizes luminance unevenness by Uniformity CorrectionFunction to achieve the uniformity of luminance on the wholescreen.■ Quantitative evaluation and visual evaluation are done beforethe shipment. Quality control along the QC guideline is conducted. |
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JVCKENWOOD
- MS-S300 is intended to be used in displaying and viewing medical Intended Use: images for diagnosis by trained medical practitioners or certified personnel. lt's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
- MS-S300 shares the same technical characteristics, application, and Substantial Equivalence: intended use as our predicate device MS35i2/ K133686.
MS-S300 is substantially equivalent to the predicate device with Conclusion: respect to technical characteristics, application and intended use. The specification of the primary component employed by the proposed device is the same as one of the predicate device, and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.
JVCKENWOOD Corporation Healthcare Business Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
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Substantial Equivalence Comparison
This comparison table shows the differences on the technical characteristics between the proposed device and the predicate device.
| Predicate deviceLCD Monitor MS35i2(ML21035) | LCD Monitor MS-S300 | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K133686 | — | — |
| Indication for Use | MS35i2 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel. It is to be used indigital mammography PACS andmodalities including FFDM. | MS-S300 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel. It is intended to beused in digital mammography PACS,digital breast tomosynthesis and modalitiesincluding FFDM. | — |
| Response Time(typical) | 40ms (On/Off) | 28ms (On/Off) | Response Time of MS-S300 is betterthan the predicate's one. |
| Resolution orMatrix Size | 3MP(1536 x 2048) | 3MP(1536 x 2048) | — |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | — |
| Backlighting | LED | LED | — |
| Maximum Luminance | Typ. 1700cd/m2 | Typ. 2000cd/m2 | The maximum luminance of MS-S300is much better than the predicate's one. |
| DICOMCalibrated Luminance | 500cd/m2 | 500cd/m2 | — |
| Viewing Angle | CR>10Horizontal: Typ.176Vertical: Typ.176 | CR>10Horizontal: Typ.178Vertical: Typ.178 | Viewing angle of MS-S300 is widerthan the predicate's one. |
| Display Area | Horizontal: 324.86mmVertical: 433.15mm | Horizontal: 324.86mmVertical: 433.15mm | — |
| Aspect Ratio | 3:4 | 3:4 | — |
| Pixel Pitch | Horizontal: 0.2115mmVertical: 0.2115mm | Horizontal: 0.2115mmVertical: 0.2115mm | — |
| Contrast Ratio | Typ. 1400:1 | Typ. 1500:1 | Contrast ratio of MS-S300 is wider than the predicate's one |
| Grayscale Tones | 10.3 bit: (1276 gradation) | 10.3 bit: (1276 gradation) | — |
| Non-UniformityCompensation | Digital Uniformity Correction System | Digital Uniformity Correction System | — |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | — |
| Scanning Frequency | DVI46.6KHz, Vertical: 30Hz (Landscape)61.9KHz, Vertical: 30Hz (Portrait)93.1KHz, Vertical: 60Hz (Landscape)123.9KHz, Vertical: 60Hz (Portrait)DisplayPort47.4KHz, Vertical: 30Hz (Landscape)63.2KHz, Vertical: 30Hz (Portrait)94.8KHz, Vertical: 60Hz (Landscape)126.3KHz, Vertical: 60Hz (Portrait) | DVI46.6KHz, Vertical: 30Hz (Landscape)61.9KHz, Vertical: 30Hz (Portrait)93.1KHz, Vertical: 60Hz (Landscape)123.9KHz, Vertical: 60Hz (Portrait)DisplayPort47.4KHz, Vertical: 30Hz (Landscape)63.2KHz, Vertical: 30Hz (Portrait)94.8KHz, Vertical: 60Hz (Landscape)126.3KHz, Vertical: 60Hz (Portrait) | — |
| Dot Clock | 216 MHz | 216 MHz | — |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | — |
| Power Consumption | 60WLess than 2W | 55WLess than 2W | Power consumption on MS-S300 is less than the predicate's one. |
| Power Management | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.2a | — |
| QA Software | Medivisor NXF-CAL | QA Medivisor AgentF-CAL | "QA Medivosior Agent" is the later software of "Medivisor NX". |
| Sensor | Built- in Front SensorBuilt-in ambient Light Sensor | Built-in front sensorBuilt-in ambient light sensorBuilt-in human presence sensor | Used for the power save function. |
| USB Ports / Standard | 1 upstream,2 downstream / Rev. 2.0 | 1 upstream,2 downstream / Rev. 2.0 | — |
| Dimensions with Stand(W x H x D) | 367.0 x 522/583 x 220.0 mm | 361.5 x 517.0 / 612.0 x 196.5 mm | — |
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Recommended Physical Laboratory Tests
| MeasurementsGuidance | MS-S300Measurements |
|---|---|
| a. Spatial resolution | MTF measurement method that uses a bar-patternimage.(Rectangle chart method) |
| b. Pixel defects(maximum counts, allowed defecttypes, and locations) | ISO13406-2 and Flat Panel Display MeasurementStandard [VESA 2001] were used. |
| c. Artifacts | Artifacts (phase or clock, ringing, ghosting, imagesticking, etc.) |
| d. Temporal response | JVCKENWOOD uses typical data provided by thepanel manufacturer.(5-95%, 10-90%, 40-60%) |
| e. Luminance(maximum, minimum, achievable,and recommended) | Lmin, and Lmax on the calibrated luminance wasconfirmed by the requirement of the "LuminanceResponse" test of AAPM-TG18. |
| f. Conformance to a grayscale-to-luminance function(e.g., DICOM GSDF) | Luminance Response at 256 digital values byAAPM-TG18 |
| g. Luminance at 30° and 45° indiagonal, horizontal, and verticaldirections at center and fourcorners | Angular dependency of luminance by AAPM-TG18 |
| h. Luminance uniformity or Muratest | Luminance Uniformity by AAPM-TG18Chromaticity by AAPM-TG18 |
| i. Stability of luminance andchromaticity response withtemperature and time of operationor on-time | 0°C, 25°C, and 40°C on Luminance response byAAPM-TG18(Power On Drift.) |
| j. Spatial noise | Noise Power Spectrum |
| k. Reflection coefficient | Specular reflection and Diffuse reflection byAAPM-TG18 |
| I. Veiling glare or small-spotcontrast | Veiling Glare test by AAPM-TG18 |
| Other | Pixel fill factor(Pixel structure and aperture ratio of pixel. |
§ 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).