(64 days)
CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 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.
It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted
MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 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 acceptance criteria for the JVC Kenwood CL-S500 (color) and MS-S500 (monochrome) LCD monitors, intended for medical image display in digital mammography PACS, digital breast tomosynthesis, and FFDM, are based on a comparison to a predicate device (CCL550i2/ K160326) and adherence to established display quality standards (AAPM-TG18 and ISO13406-2).
The study primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and performance of the new devices to the predicate device and relevant industry standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" as a separate, quantitative target for each metric beyond direct comparison to the predicate device or a reference to a standard (e.g., AAPM-TG18 passing criteria). However, the "Explanation of Differences" column in the substantial equivalence comparison tables implicitly suggests the acceptance criteria where the new device must be equivalent to or better than the predicate, or meet the requirements of the specified standard.
| Metric (Acceptance Criteria Implicitly Derived) | Predicate Device Performance (CCL550i2) | CL-S500 Performance (Color) | MS-S500 Performance (Monochrome) | Explanation / Conformance |
|---|---|---|---|---|
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | 25ms (On/Off) | Equivalent |
| Resolution or Matrix Size | 5MP (2048 x 2560) | 5MP (2048 x 2560) | 5MP (2048 x 2560) | Equivalent |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | CL-S500 Equivalent; MS-S500 different (monochrome) but intended use is for monochrome imaging, so acceptable. |
| Backlighting | LED | LED | LED | Equivalent |
| Maximum Luminance | Min. 700cd/m², Typ. 1000cd/m² | Min. 920cd/m², Typ. 1150cd/m² | Min. 2400cd/m², Typ. 3000cd/m² | CL-S500: Better; MS-S500: Better |
| DICOM Calibrated Luminance | 500cd/m² | 500cd/m² | 1000cd/m² | CL-S500: Equivalent; MS-S500: Better |
| Viewing Angle (CR > 50) | H: Typ. 176°, V: Typ. 176° | H: Typ. 178°, V: Typ. 178° | H: Typ. 178°, V: Typ. 178° | Both: Better |
| Display Area | 337.92mm (H), 422.4mm (V) | 337.92mm (H), 422.4mm (V) | 337.92mm (H), 422.4mm (V) | Equivalent |
| Aspect Ratio | 4:5 | 4:5 | 4:5 | Equivalent |
| Pixel Pitch | 0.165mm (H), 0.165mm (V) | 0.165mm (H), 0.165mm (V) | 0.165mm (H), 0.165mm (V) | Equivalent |
| Contrast Ratio | Min. 1000:1, Typ. 1300:1 | Min. 1600:1, Typ. 2000:1 | Min. 1600:1, Typ. 2000:1 | Both: Better |
| Grayscale Tones (DisplayPort) | 10-bit (1024 from 65,473) | 10-bit (1.073B, 1024 from 16,369) | 10-bit (1024 from 16,369) | CL-S500: Different palette size, but passes AAPM-TG18. MS-S500: Different palette size, but passes AAPM-TG18. Considered equivalent as they meet standard. |
| Non-Uniformity Compensation | Digital Uniformity correction System | Digital Uniformity correction System | Digital Uniformity correction System | Equivalent |
| Input Video Signal | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 | Equivalent |
| Scanning Frequency | Portrait: H:129.1KHz, V:50Hz; Landscape: H:103.5KHz, V:50Hz | Portrait: H:129.1KHz, V:50Hz; Landscape: H:103.5KHz, V:50Hz | Portrait: H:129.1KHz, V:50Hz; Landscape: H:103.5KHz, V:50Hz | Equivalent |
| Dot Clock | 285 MHz | 285 MHz | 285 MHz | Equivalent |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | Equivalent |
| Power Consumption | 95W (operational), <2W (standby) | 95W (operational), <1W (standby) | 80W (operational), <1W (standby) | Both: Equivalent or Better (standby) |
| Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.2a | DVI DMPM, DisplayPort 1.2a | Equivalent (newer DisplayPort standard) |
| QA Software | QA Medivisor / Medivisor NX, F-CAL | QA Medivisor / Medivisor NX, F-CAL | QA Medivisor / Medivisor NX, F-CAL | Equivalent |
| Sensor | Built-in Front Sensor, Built-in Ambient Light Sensor | Built-in Front Sensor, Built-in Ambient Light Sensor | Built-in Front Sensor, Built-in Ambient Light Sensor | Equivalent |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 2.0 | 1 upstream, 2 downstream / Rev. 2.0 | 1 upstream, 2 downstream / Rev. 2.0 | Equivalent |
| Dimensions w/o Stand | (AR,N) 474.5x390x98.1mm, (F) 474.5x390x103.7mm | (G) 361.5x517/612x196.5mm | (G) 361.5x517/612x196.5mm | Different physical dimensions (acceptable as long as performance is equivalent) |
| Spatial Resolution (MTF) | (Implied to meet standard) | MTF measurement method that uses a bar-pattern image. (Rectangle chart method) | MTF measurement method that uses a bar-pattern image. (Rectangle chart method) | Tested against industry-standard method. |
| Pixel defects | (Implied to meet standard) | ISO13406-2 and Flat Panel Display Measurement Standard [VESA 2001] used. | ISO13406-2 and Flat Panel Display Measurement Standard [VESA 2001] used. | Tested against industry-standard method. |
| Artifacts | (Implied to meet standard) | Artifacts (phase or clock, ringing, ghosting, image sticking, etc.) | Artifacts (phase or clock, ringing, ghosting, image sticking, etc.) | Visual and quantitative evaluation for acceptability. |
| Temporal response | (Implied to meet standard) | Typical data provided by panel manufacturer (5-95%, 10-90%, 40-60%) | Typical data provided by panel manufacturer (5-95%, 10-90%, 40-60%) | Data from manufacturer used. |
| Luminance (min, max, calibrated) | (Implied to meet standard) | Lmin, and Lmax on the calibrated luminance confirmed by AAPM-TG18 "Luminance Response" test. | Lmin, and Lmax on the calibrated luminance confirmed by AAPM-TG18 "Luminance Response" test. | Passed AAPM-TG18. |
| Grayscale-to-luminance conformance | (Implied to DICOM GSDF) | Luminance Response at 256 digital values by AAPM-TG18 | Luminance Response at 256 digital values by AAPM-TG18 | Passed AAPM-TG18 for DICOM GSDF. |
| Angular dependency of luminance | (Implied to meet standard) | Angular dependency of luminance by AAPM-TG18 | Angular dependency of luminance by AAPM-TG18 | Passed AAPM-TG18. |
| Luminance uniformity / Mura | (Implied to meet standard) | Luminance Uniformity by AAPM-TG18, Chromaticity by AAPM-TG18 | Luminance Uniformity by AAPM-TG18 | Passed AAPM-TG18. |
| Stability of luminance/chromaticity | (Implied to meet standard) | 0°C, 25°C, and 40°C on Luminance response by AAPM-TG18 (Power On Drift.) | 0°C, 25°C, and 40°C on Luminance response by AAPM-TG18 (Power On Drift.) | Passed AAPM-TG18. |
| Spatial noise | (Implied to meet standard) | Noise Power Spectrum | Noise Power Spectrum | Tested. |
| Reflection coefficient | (Implied to meet standard) | Specular reflection and Diffuse reflection by AAPM-TG18 | Specular reflection and Diffuse reflection by AAPM-TG18 | Passed AAPM-TG18. |
| Veiling glare / small-spot contrast | (Implied to meet standard) | Veiling Glare test by AAPM-TG18 | Veiling Glare test by AAPM-TG18 | Passed AAPM-TG18. |
Note: For metrics not explicitly listed in the comparison table, such as Spatial Resolution, Pixel Defects, Artifacts, etc., the document refers to studies conducted according to specific standards (AAPM-TG18, ISO13406-2, VESA 2001). The "reported device performance" for these would be that the devices "pass" or "meet" the requirements of those standards.
2. Sample size used for the test set and the data provenance:
The document describes the testing performed on the devices themselves rather than on a dataset of medical images. The "test set" here refers to the actual monitors.
- Sample size: Not explicitly stated as a number of units, but implied to be representative production units. The statement "Quantitative evaluation and visual evaluation are done before the shipment" (for both CL-S500 and MS-S500) indicates that each unit undergoes testing.
- Data provenance: The performance data for the CL-S500 and MS-S500 are results of physical tests and measurements performed by JVC KENWOOD Corporation in Japan, as indicated by the company's address and the "Date Prepared" for the 510(k) summary. These are prospective tests on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this submission. The "ground truth" for evaluating these monitors is defined by established technical measurement standards (e.g., AAPM-TG18 guidance, DICOM GSDF, ISO13406-2, VESA 2001) and comparisons to known specifications of a predicate device, not by expert human interpretation of medical images displayed on the monitors.
4. Adjudication method for the test set:
Not applicable. The product is a hardware display, and its performance is evaluated by objective technical measurements against established standards, not by human adjudication of diagnostic interpretations.
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 submission is for a medical display monitor, not an AI-powered diagnostic algorithm. Therefore, no MRMC study on human reader performance with or without AI assistance was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is objective technical specifications and adherence to established industry standards for medical displays. These include:
- DICOM Grayscale Standard Display Function (GSDF): For grayscale-to-luminance function conformance.
- AAPM Task Group 18 (AAPM-TG18) Guidance: For various display characteristics like luminance response, angular dependency, uniformity, reflection, and veiling glare.
- ISO13406-2 and Flat Panel Display Measurement Standard [VESA 2001]: For pixel defects.
- Predicate Device Specifications: For demonstrating substantial equivalence to a previously cleared device.
8. The sample size for the training set:
Not applicable. This is a hardware device (display monitor), not a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is a hardware device (display monitor), not a machine learning algorithm.
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July 2, 2019
JVC Kenwood Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
Re: K191137
Trade/Device Name: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: June 3, 2019 Received: Jun 5, 2019
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 of medical device-related adverse events) (21 CFR 803) for
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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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191137
Device Name 5MP Color LCD Monitor CL-S500 5MP Monochrome LCD Monitor MS-S500
Indications for Use (Describe)
CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're 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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510(k) SUMMARY
Submitted Information: JVC KENWOOD 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 May 23, 2019 Date Prepared: CL-S500 Device Name: 5MP Color LCD Monitor 5MP Monochrome LCD Monitor MS-S500 Common Name: CL-S500 (CL-S500xxxxx) MS-S500 (MS-S500xxxxx) Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) 21.3 inch (54cm) Color LCD Monitor CCL550i2(CL21550) Predicate Device: (CCL550i2/ K160326) Requlation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: PGY Device Description: CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 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. ■ It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of
JVC KENWOOD Corporation
Healthcare Business Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
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luminance and color on the whole screen.
■ Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted
MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 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. CL-S500 and MS-S500 are intended to be used in displaying and Intended Use: viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS. digital breast tomosynthesis and modalities including FFDM. Substantial Equivalence: CL-S500 and MS-S500 share the same technical characteristics, application, and intended use as our predicate device CCL550i2/ K160326. CL-S-500 and MS-S500 are substantially equivalent to the predicate Conclusion: device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are the same as those of the predicate device, and other differences have been independently validated. Any differences
JVC KENWOOD Corporation
between the devices do not affect safety or effectiveness.
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Substantial Equivalence Comparison
| Predicate deviceLCD Monitor CCL550i2(CL21550) | LCD Monitor CL-S500 | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K160326 | K191137 | - |
| Indication for use | CCL550i2 is intended to beused in displaying andviewing medical images fordiagnosis by trained medicalpractitioners.It is to be used in digitalmammography PACS, digitalbreast tomosynthesis andmodalities including FFDM. | CL-S500 is intended to beused in displaying andviewing medical images fordiagnosis by trained medicalpractitioners or certifiedpersonnel.It is intended to be used indigital mammography PACS,digital breast tomosynthesisand modalities includingFFDM. | - |
| Response Time(typical) | 25ms (On/Off) | 25ms (On/Off) | - |
| Resolution orMatrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| Maximum Luminance | Min.700cd/m²Typ. 1000cd/m² | Min. 920cd/m²Typ. 1,150cd/m² | The maximum luminance of the predicate device isMin.700cd/m² and one of CL-S500 is Min.920cd/m².Therefore, CL-S500 is equivalent to or better than thepredicate device. |
| DICOMCalibrated Luminance | 500cd/m² | 500cd/m² | The calibrated luminance is the same between CL-S500and the predicate device. It's 500cd/m². |
| Viewing Angle | CR>50Horizontal: Typ.176Vertical: Typ.176 | CR>50Horizontal: Typ.178Vertical: Typ.178 | Compared with the predicate device, CL-S500 isequivalent to or better than the predicate device. |
| Display Area | Horizontal: 337.92mmVertical: 422.4mm | Horizontal: 337.92mmVertical: 422.4mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.165mmVertical: 0.165mm | - |
| Contrast Ratio | Min.1000 : 1Typ. 1300 : 1 | Min.1600 : 1Typ. 2000 : 1 | The contrast ratio is the predicate device is Typ.1300:1,and the one of the proposed device CL-S500 isTyp.1600:1. Therefore, CL-S500 is equivalent to orbetter than the predicate device. |
| Grayscale Tones | 10-bit (DisplayPort): 1,024from a palette of 65,473tones8-bit: 256 from a palette of65,473 tones | 10-bit (DisplayPort): 1.073 billion1024 from a palette of 16,369tones8-bit(DVI): 16.77 million 256from a palette of 16,369tones | - |
| Non-UniformityCompensation | Digital Uniformity correctionSystem | Digital Uniformity correctionSystem | - |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | - |
| Scanning Frequency | Portrait:Horizontal:129.1KHzVertical:50HzLandscape:Horizontal:103.5KHzVertical:50Hz | Portrait:Horizontal:129.1KHzVertical:50HzLandscape:Horizontal:103.5KHzVertical:50Hz | - |
| Dot Clock | 285 MHz | 285 MHz | - |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | - |
| Power Consumption | 95WLess than 2W | 95WLess than 1W | - |
| Power Management | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.2a | - |
| QA Software | QA Medivisor / Medivisor NXF-CAL | QA Medivisor / Medivisor NXF-CAL | - |
| Sensor | Built-in Front Sensor | Built-in Front Sensor | - |
| Built-in ambient Light Sensor | Built-in ambient Light Sensor | - | |
| USB Ports / Standard | 1 upstream,2 downstream / Rev. 2.0 | 1 upstream,2 downstream / Rev. 2.0 | - |
| Dimensionsw/o Stand(W x H x D) | (AR, N) 474.5 x 390 x 98.1 mm(F) 474.5 x 390 x 103.7 mm | (G) 361.5 x 517/612 x 196.5 mm | - |
This comparison table shows the differences on the technical characteristics between the proposed device.
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| Predicate deviceLCD Monitor CCL550i2(CL21550) | LCD Monitor MS-S500 | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K160326 | K191137 | - |
| Indication for use | CCL550i2 is intended to beused in displaying andviewing medical images fordiagnosis by trained medicalpractitioners.It is to be used in digitalmammography PACS, digitalbreast tomosynthesis andmodalities including FFDM. | MS-S500 is intended to beused in displaying andviewing medical images fordiagnosis by trained medicalpractitioners or certifiedpersonnel.It is intended to be used indigital mammography PACS,digital breast tomosynthesisand modalities includingFFDM. | - |
| Response Time(typical) | 25ms (On/Off) | 25ms (On/Off) | - |
| Resolution orMatrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Monochrome LCD Panel(IPS) | The difference between monochrome and color |
| Backlighting | LED | LED | - |
| Maximum Luminance | Min.700cd/m2Typ. 1000cd/m2 | Min. 2,400cd/m2Typ. 3,000cd/m2 | The maximum luminance of the predicate device isMin.700cd/m2 and one of MS-S500 is Min.2400cd/m2. |
| DICOMCalibrated Luminance | 500cd/m² | 1,000 cd/m² | Therefore, MS-S500 is equivalent to or better than thepredicate device.The calibrated luminance of the predicate device isMin.500cd/m² and one of MS-S500 is Min.1000cd/m².Therefore, MS-S500 is equivalent to or better than thepredicate device. |
| Viewing Angle | CR>50Horizontal: Typ.176Vertical: Typ.176 | CR>50Horizontal: Typ.178Vertical: Typ.178 | Compared with the predicate device, MS-S500 isequivalent to or better than the predicate device. |
| Display Area | Horizontal: 337.92mmVertical: 422.4mm | Horizontal: 337.92mmVertical: 422.4mm | |
| Aspect Ratio | 4:5 | 4:5 | |
| Pixel Pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.165mmVertical: 0.165mm | |
| Contrast Ratio | Min.1000 : 1Typ. 1300 : 1 | Min.1600 : 1Typ.2000 : 1 | The contrast ratio is the predicate device is Typ.1300:1,and the one of the proposed device MS-S500 isTyp.2000:1. Therefore, MS-S500 is equivalent to orbetter than the predicate device. |
| Grayscale Tones | 10-bit (DisplayPort): 1,024from a palette of 65,473tones8-bit: 256 from a palette of65,473 tones | 10-bit (DisplayPort): 1,024from a palette of 16,369tones8-bit (DVI) : 256 from apalette of16,369 tones | Maximum bit depth by DisplayPort is 10 bit, and one byDVI is 8 bit.Tone between the predicate device and our proposeddevices are different. But they pass the exams inAAPM-TG18 4.3 "Luminance Response".Therefore, they are equivalent to the predicate device. |
| Non-UniformityCompensation | Digital Uniformity correctionSystem | Digital Uniformity correctionSystem | |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | |
| Scanning Frequency | Portrait:Horizontal:129.1KHzVertical:50HzLandscape:Horizontal:103.5KHzVertical:50Hz | Portrait:Horizontal:129.1KHzVertical:50HzLandscape:Horizontal:103.5KHzVertical:50Hz | |
| Dot Clock | 285 MHz | 285 MHz | |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | |
| Power Consumption | 95WLess than 2W | 80WLess than 1W | - |
| Power Management | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.2a | - |
| QA Software | QA Medivisor / Medivisor NXF-CAL | QA Medivisor / Medivisor NXF-CAL | - |
| Sensor | Built- in Front SensorBuilt-in ambient Light Sensor | Built- in Front SensorBuilt-in ambient Light Sensor | - |
| USB Ports / Standard | 1 upstream,2 downstream / Rev. 2.0 | 1 upstream,2 downstream / Rev. 2.0 | - |
| Dimensionsw/o Stand(W x H x D) | (AR, N) 474.5 x 390 x 98.1 mm(F) 474.5 x 390 x 103.7 mm | (G) 361.5 x 517/612 x 196.5 mm | - |
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Recommended Physical Laboratory Tests
| MeasurementsGuidance | MS-S500, CL-S500Measurements |
|---|---|
| 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 | JVC KENWOOD 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).