(77 days)
MS-S200 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 (54cm) Monochrome LCD Monitor
1600 x1200 (landscape)
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.
This document, a 510(k) summary for the JVCKENWOOD 2MP Monochrome LCD Monitor MS-S200, does not describe a study involving an AI/CADe device or human readers interpreting medical images. Instead, it is a submission for a medical display monitor, which is a piece of hardware.
Therefore, the information requested in your prompt (acceptance criteria for an AI device, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
The document focuses on demonstrating substantial equivalence of the new monitor (MS-S200) to a predicate device (MS25i2) based on technical specifications and performance characteristics, not on clinical performance for diagnosis.
To answer your prompt based on the provided text, I can only extract information related to the monitor's performance criteria, not those of an AI diagnostic tool.
Here's what can be extracted from the document regarding the monitor's performance and validation:
1. A table of acceptance criteria and the reported device performance:
The document states: "All items in monitor specification have met the acceptance criteria according to the standard, AAPM-TG18 and ISO 13406-2." It then lists several specifications where the new monitor actually improves upon the predicate device.
| Specification | Predicate Device (MS25i2) Performance | Proposed Device (MS-S200) Performance | Acceptance Criteria (Implicit: Meets or Exceeds Predicate, and complies with AAPM-TG18 and ISO 13406-2) |
|---|---|---|---|
| Response Time (typical) | 40 ms typ. (T on + T off 10%-90%) | 19 ms typ. (T on + T off 10%-90%) | Superior to predicate and conforms to standards. |
| Contrast Ratio | 1400:1 | 1800:1 | Superior to predicate and conforms to standards. |
| Viewing Angle (CR>10:1) | Horizontal: Typ.176, Vertical: Typ.176 | Horizontal: Typ.178, Vertical: Typ.178 | Superior to predicate and conforms to standards. |
| Max Luminance | 1900 cd/m² typ. | 1900 cd/m² typ. | Meets predicate and conforms to standards. |
| DICOM Calibrated Luminance | 0.8 - 410 cd/m² | 0.8 - 410 cd/m² | Meets predicate and conforms to standards. |
| Resolution or Matrix Size | 1200 x 1600 (Portrait) | 1200 x 1600 (Portrait) | Meets predicate and conforms to standards. |
| Grayscale Tones | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | Meets predicate and conforms to standards. |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), ICES-003 (Class B), MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), ICES-003 (Class B), MDR/CE, RCM, VCCI-B (Class B) | Covers existing and adds RCM. Conforms to specified safety standards. |
Regarding the other points, they are not applicable because this is a hardware device (monitor), not an AI diagnostic algorithm:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on monitor characteristics, not a clinical data test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for a monitor. Its performance is measured by objective technical standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not AI and does not involve human readers in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. No AI model is being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a medical display monitor, not an AI diagnostic device. The "study" proving it meets acceptance criteria refers to technical verification against industry standards (AAPM-TG18, ISO 13406-2) and comparison to a predicate device's hardware specifications, not a clinical trial or AI performance evaluation.
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April 23, 2021
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Jvckenwood Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
Re: K210345
Trade/Device Name: 2MP Monochrome LCD Monitor MS-S200 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 29, 2021 Received: February 5, 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 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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Indications for Use
510(k) Number (if known) K210345
Device Name 2MP Monochrome LCD Monitor MS-S200
Indications for Use (Describe)
MS-S200 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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JVCKENWOO DID
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: | April 13, 2021 |
| Device Name: | 2MP Monochrome LCD Monitor MS-S200 |
| Common Name: | MS-S200(MS-S200xxxxx) |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54cm) Monochrome LCD Monitor MS25i2 (ML21025)(MS25i2/ K133511) |
| Device Description: | 21.3 inch (54cm) Monochrome LCD Monitor1600 x1200 (landscape) |
| 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. | |
| Intended Use: | MS-S200 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. |
| Substantial Equivalence: | MS-S200 shares the same technical characteristics, application, andintended use as our predicate device MS25i2/K133511. |
| Validation for PerformanceSpecification: | All items in monitor specification have met the acceptance criteriaaccording to the standard, AAPM-TG18 and ISO 13406-2. |
| Changes in the newmonitor, MS-S200: | 1) Response Time19 ms (new monitor:MS-S200) vs. 40 ms (predicate device:MS25i2)The specification of the proposed device (MS-S200) is superior to that ofthe predicate device (MS25i2).2) Contrast Ratio1800:1 (new monitor:MS-S200) vs. 1400:1 (predicate device:MS25i2)The specification of the proposed monitor (MS-S200) is superior to thatof the predicate device (MS25i2) |
| Conclusion: | Based on our specification confirmation and physical evaluation asabove, the proposed device is substantial equivalent to the predicate |
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JVCKENWOOD
device.
JVCKENWOOD Corporation
Healthcare Business Division
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Substantial Equivalence Comparison
| Predicate DeviceMS25i2 (ML21025) | Proposed DeviceMS-S200 (MS-S200xxxxx) | Explanation ofDifferences | Response Time (typical) | T on + T off (10%-90%)40 ms typ. | T on + T off (10%-90%)19 ms typ. | The specification of theproposed device issuperior to that of thepredicate device. | |
|---|---|---|---|---|---|---|---|
| 510(k) Number | K133511 | Not Known | — | Aspect Ratio | 3:4 | 3:4 | – |
| Indication for Use | 21.3 inch (54 cm) Monochrome 2M pixel LCDMonitor MS25i2 (ML21025) is intended to beused in displaying and viewing medical imagesfor diagnosis by trained medical practitioners orcertified personnel.It is not meant to be used in digitalmammography. | 21.3 inch (54 cm) Monochrome 2M pixel LCDMonitor MS-S200 (MS-S200xxxxx) isintended to be used in displaying and viewingmedical images for diagnosis by trainedmedical practitioners or certified personnel.It is not meant to be used in digitalmammography. | — | Pixel Pitch | Horizontal: 0.270 mm, Vertical: 0.270 mm | Horizontal: 0.270 mm, Vertical: 0.270 mm | – |
| Resolution or Matrix Size | Portrait : 1200 x 1600 (4800 subpixel)Landscape : 1600 (4800 subpixel) x 1200 | Portrait : 1200 x 1600 (4800 subpixel)Landscape : 1600 (4800 subpixel) x 1200 | — | Contrast Ratio | 1400:1 | 1800:1 | The specification of theproposed device issuperior to that of thepredicate device. |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | — | Grayscale Tones | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | – |
| Backlighting | LED | LED | — | Non-UniformityCompensation | N/A | N/A | – |
| Maximum Luminance | 1900 cd/m² typ. | 1900 cd/m² typ. | — | Input Video Signal | DVI-D, DisplayPort | DVI-D, DisplayPort | – |
| DICOMCalibrated Luminance | 0.8 - 410 cd/m² | 0.8 - 410 cd/m² | — | USB Ports / Standard | USB:Upstream port (x1), Downstream port (x2)Ver.2.0 | USB:Upstream port (x1), Downstream port (x2)Ver.2.0 | – |
| Viewing Angle | CR>10:1Viewing angle :Horizontal: Typ.176 Vertical: Typ.176 | CR>10:1Viewing angle :Horizontal: Typ.178 Vertical: Typ.178 | The specification of theproposed device issuperior to that of thepredicate device. | Scanning Frequency | DVI74.1KHz, Vertical: 60Hz (Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait) | DVI74.1KHz, Vertical: 60Hz (Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait) | – |
| Display Area | Horizontal: 324.0 mm, Vertical: 432.0 mm | Horizontal: 324.0 mm, Vertical: 432.0 mm | — | Maximum Image Clock | 162MHz | 162MHz | – |
| Rated | AC100-240V, 50/60Hz 1.5 – 0.6A | AC100-240V, 50/60Hz 2.2 – 1.1A | The difference does notaffect diagnosis. |
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| Luminance Calibration(Optional) | Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite) | Software: F-CAL, Medivisor AgentCalibration Sensor (Optional): i1Display (X-Rite) | Application software andcalibration sensor of theproposed device currentlysupport those of thepredicate device. |
|---|---|---|---|
| Sensor | Built-in Front Sensor | Built-in Front Sensor | Adding human presencesensor does not affectdiagnosis, only for energy |
| Built-in Ambient Light Sensor | Built-in Ambient Light Sensor | saving. | |
| None | Built-in Human presence sensor | ||
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), ICES-003 (Class B),MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), ICES-003 (Class B),MDR/CE, RCM, VCCI-B (Class B) | Safety standards of thepredicate device currentlysupport those of theproposed device.(RCM is added) |
| Weight & Dimension | Net: Approximately 12.0kgLandscape:474.0 (w) x 468.4 - 529.9 (H) x 220.0 (D) mmPortrait:367.0 (w) x 521.9 - 583.4 (H) x 220.0 (D) mmPacked: Approximately 15.0kg470 (W) x 670 (H) x 340 (D) mm | Net: Approximately 9.3 kg (Filter Model)Approximately 8.9 kg (Normal Model)Landscape:493.0 (w) x 451.3 – 546.3 (H) x 196.5 (D) mmPortrait:361.5 (w) x 517.0 - 612.0 (H) x 196.5 (D) mmPacked: Approximately 12.3kg (Filter Model)Approximately 11.9kg (Normal Model)585 (W) x 580 (H) x 285 (D) mm | The difference does notaffect diagnosis. |
§ 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).