(129 days)
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
The provided document describes a 510(k) premarket notification for a medical display monitor, the "12MP Color LCD Monitor (C1216W, C12***)". The primary purpose of this document is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device, the EIZO Corporation's 12MP Color LCD Monitor, RadiForce RX1270 (K200485).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance in a tabular format with corresponding reported device performance. Instead, it details performance testing conducted to demonstrate equivalence to the predicate device. The performance characteristics of the proposed device are compared to the predicate device in several tables (Table 1 Intended Use Comparison, and Table 2 General Comparison, which is spread across pages 7 and 8 but not fully reproduced here with all details).
However, based on the "Performance Testing" section (page 9-10), the implied "acceptance criterion" for each test is that the device should demonstrate characteristics equivalent to those of the predicate device or that any differences do not affect observer performance.
Here's a summary of the performance testing performed, which serves as the basis for demonstrating equivalence:
| Acceptance Criteria (Implied from Performance Testing) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (according to AAPM TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device, RadiForce RX1270 except some items, each of which was determined that it would not affect observer's performance." (This general statement applies to all listed performance tests, suggesting compliance for DICOM GSDF.) |
| Luminance non-uniformity characteristics (according to TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Luminance stability and chromaticity response with temperature (0°C, 25°C, 40°C) (according to AAPM-TG18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Chromaticity non-uniformity characteristics (according to TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Luminance at angles of 30º and 45º (diagonal, horizontal, vertical; center and corners) (by AAPM-TG18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Temporal response (using typical data from panel manufacturer) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Measurement of Luminance | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." (Specific maximum luminance and DICOM calibrated luminance values are provided in Table 2, page 7, showing slight differences from the predicate which are presumably deemed acceptable as per the general statement.) |
| Visual check for presence/absence of miscellaneous artifacts (according to TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Spatial noise measurement (by noise power spectrum) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Reflection coefficient measurement (specular and diffuse reflection) (by TG18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Veiling glare measurement (small-spot contrast, by TG-18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Spatial resolution (expressed as modulation transfer function (MTF)) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Maximum number allowed for each type of pixel defects/faults | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Color tracking and Gray tracking measurement | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Pixel fill factor measurement (pixel structure and aperture ratio, etc.) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
2. Sample size used for the test set and the data provenance
The document describes bench tests that were performed on the device. It does not mention a "test set" consisting of patient data or clinical images. The testing is based on the device itself and its intrinsic technical characteristics. Therefore, there's no information about sample size for a test set in the conventional sense of a clinical or image-based study, nor about data provenance (country of origin, retrospective/prospective). The tests were conducted on the physical devices C1216W and C12***.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is a bench test of a display monitor, not an interpretative study requiring expert ground truth for medical images.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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
An MRMC comparative effectiveness study was not done. This submission is for a medical display monitor and does not involve AI assistance or human reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a display monitor, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" in this context refers to established technical standards and measurement specifications, specifically the AAPM Task Group 18 (TG18 guideline), which outlines procedures for evaluating display performance for medical imaging systems. These standards serve as the reference for evaluating the display's inherent technical characteristics.
8. The sample size for the training set
This information is not applicable as the device is a display monitor and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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Shenzhen Beacon Display Technology Co., Ltd. % Li Yafei Official Correspondent 15F, Building 6, Hengda Shishang Huigu (East), Fulong Road, Dalang Subdistrict. Longhua Shenzhen, Guangdong 518109 CHINA
Re: K231026
Trade/Device Name: 12MP Color LCD Monitor C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: July 19, 2023 Received: July 19, 2023
Dear Li Yafei:
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.
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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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Zhkke
, for
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231026
Device Name
12MP Color LCD Monitor (C1216W, C12** (1*) = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models))
Indications for Use (Describe)
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
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
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 17, 2023
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|---|---|
| Address: | 15F, Building 6, Hengda Shishang Huigu(East), Fulong Road, Dalang |
| Subdistrict, Longhua, Shenzhen, 518109 China | |
| Contact Name: | Li Yafei |
| Telephone No.: | +86-024-88087610 |
| Fax No.: | +86-024-88087629 |
| Email Address: | liyf@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| • Trade Name/Model: | 12MP Color LCD Monitor (C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)) |
|---|---|
| • Common Name: | 12MP Color LCD Monitor |
- 0 Classification Name: Medical Image Management and Processing System
- Regulation Number: 21 CFR 892.2050
- PGY 0 Product code:
- O Classification Panel: Radiology
- Device Class: ll O
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows:
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EIZO Corporation, 12MP Color LCD Monitor, RadiForce RX1270, RX1270-AR has been cleared by FDA through 510(k) No. K200485 (Decision Date - March 23, 2020).
5. Description of the Device [21 CFR 807.92(a) (4)]
The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6. Intended Use [21 CFR 807.92(a)(5)]
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
7. Indications for Use
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
| Panel characteristics: | |
|---|---|
| Screen technology | 31", TFT, color, LCD screen, AG type |
| Active area (H x V) | 652.68 x 435.12 mm |
| Pixel pitch | 0.1554 mm (H) x 0.1554 mm (V) |
| Resolution | 4200 x 2800 Pixels |
| Contrast ratio | 1050:1 (minimum), 1500:1 (typical) |
| Viewing angle (CR > 10) | Horizontal: 178° (typical) |
| Vertical: 178° (typical) | |
| Screen brightness | 1200cd/m² (typical) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Lifetime of backlight | 50000 hours (minimum) |
| Response time (Gray to Gray) | 14ms (typical ) |
| Color support | 1.07G |
| Power supply: | |
| Power connection | Power cord connector with protective conductor,IEC60320-C14 |
| Input voltage | AC 100-240V 50/60Hz |
| Current consumption | 2.4-1.0 A |
| Power consumption | ≤200W |
| Standby | < 0.5 W |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
| Back | Power switch * 1 AC socket * 1 HDMI * 2 Display Port * 3 Service Connector * 1 USB * 7 |
| Mechanical characteristics: | |
| Housing components | Plastic, Metal |
| Ventilation openings | Natural heat dissipation |
| Degree of protection | IP20 |
| Climatic conditions: | |
| Operational temperature | 0°C ~40°C |
| Operational humidity | 15%~ 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C ~ +60°C |
| Transport and storage humidity | 10% ~ 90% Relative humidity, no condensation |
| Operational pressure | 700 hPa~1060 hPa |
| Safety regulations: | |
| Safety standards | IEC 60601-1EN 60601-1ANSI/AAMI ES60601-1CAN/CSA-C22.2 NO. 60601-1:14 |
| Conformity | CCC,CE,FCC,TUV,CB,CECP |
| Dimension: | |
| With packing (W x H x D) | 840 x 643 x321 mm |
| Weight: | |
| Net weight | 18.3± 1 kg |
| Gross weight | 22.8 ± 1 kg |
8. Technological Characteristics [21 CFR 807.92(a)(6)]
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9. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
9.1 Intended uses:
| Table 1 Intended Use Comparison | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------- |
| ID | ComparisonItem | Proposed Device | Predicate Device |
|---|---|---|---|
| 12MP Color LCD Monitor(C1216W ,C12***) | 12MP Color LCD Monitor(RX1270, RX1270-AR) | ||
| 1 | Intended Use | These products are indicatedfor use in displayingradiological images (includingfull-field digital mammographyand digital breasttomosynthesis) for review,analysis, and diagnosis bytrained medical practitioners. | The 12MP Color LCD Monitor(RX1270, RX1270-AR)" isintended to be used in displayingradiological images (includingfull-field digital mammographyand digital breast tomosynthesis)for review, analysis, anddiagnosis by trained medicalpractitioners. |
| Attributes | Proposed Device12MP Color LCDMonitor(C1216W ,C12***) | Predicate Device12MP Color LCDMonitor(RX1270, RX1270-AR) | Explanation ofDifference |
| Display Technology | TFT Color LCD Panel(IPS) | TFT Color LCD Panel(IPS) | - |
| Screen size | 78.4cm / 31" | 78.4cm / 30.9" | Different screenprovided by thedifferentmanufacturer |
| Resolution | 4200 x 2800 (3:2 aspect ratio) | 4200 x 2800 (3:2 aspect ratio) | - |
| Pixel pitch | 0.1554 x 0.1554 mm | 0.1554 x 0.1554 mm | - |
| Backlight type | LED | LED | - |
| Maximum luminance | 1200 cd/m² | 1200 cd/m² | Different screenprovided by thedifferentmanufacturer |
| DICOM calibrated luminance | |||
| 450 cd/m² | 500 cd/m² | Different screenprovided by thedifferentmanufacturer | |
| Contrast Ratio (typical) | |||
| 1500:1 | 1500:1 | - | |
| Response Time (typical) | |||
| 14 ms(Gray to Gray) | 12 ms(black-white-black) | Different designscheme. | |
| Frame rate and refresh rate | |||
| DigitalScanningFrequency(H / V) | HDMI: 31.5 - 133.32kHz / 30 - 60 HzDisplayPort: 31.5 -172.8 kHz / 60 Hz | HDMI: 31 - 160 kHz / 59- 61 Hz(VGA Text: 69 - 71 Hz)DisplayPort: 31 - 175kHz / 29 -61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode:29.5 - 30.5 Hz, 59 - 61Hz | Different designscheme. |
| AnalogScanningFrequency(H / V) | - | HDMI: 31 - 160 kHz / 59- 61 Hz(VGA Text: 69 - 71 Hz)DisplayPort: 31 - 175kHz / 29 -61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode:29.5 - 30.5 Hz, 59 - 61Hz | Different designscheme. |
| Display Interface | |||
| Input videosignals | HDMI x 2,DisplayPort x 2 | DisplayPort x 2,HDMI | Different designscheme. |
| Output videosignals | DisplayPort x 1 | - | Different designscheme. |
| Video bandwidth | |||
| HDMI: 594MHzDisplayPort:753.25MHz | HDMI: 260MHzDisplayPort: 765MHz | Different designscheme. | |
| Ambient light sensing | |||
| Ambient lightsensor | Yes | Yes | Different designscheme. |
| Luminance calibration tools | |||
| Integrated opticalsensorExternal optical sensorCalibrationsoftware:BeaconMonitor Manage | Integrated opticalsensorExternal optical sensorCalibration software:RadiCS | Different designscheme. | |
| Quality-control procedures | |||
| Beacon MonitorManage | Software: RadiCS | Different designscheme. |
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9.2 Comparison table
Table 2 General Comparison
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It is clear that the technological characteristic differences discussed above do not affect the safety and the effectiveness of the C1216W and C12***.
9.3 Performance Testing
According to the instructions in" Guidance for Industry and Food and Drug Administration Staff Display Devices for Diagnostic Radiology", the bench tests were performed on C1216W and C12*** as below.
- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline).
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- O Measure the luminance stability and chromaticity response with the temperature 0°C,
25°C and 40°C on Luminance response by AAPM-TG18.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
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- Measure the luminance at the angles of 30º and 45º in diagonal, horizontal and vertical directions at center and four corners by AAPM-TG18.
- Measure the temporal response using the typical data provided by the panel manufacturer.
- 0 Measurement of Luminance
- 0 Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- 0 Measure the spatial noise by noise power spectrum.
- 0 Measure the reflection coefficient with specular reflection and diffuse reflection by TG18.
- Measure the veiling glare of small-spot contrast performing veiling glare test by TG-18.
- O Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
- 0 Measurement of Color tracking and Gray tracking
- Measure pixel fill factor like pixel structure and aperture ratio etc.
The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device, RadiForce RX1270 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C1216W and C12**.
10. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd. concludes that:
- The intended use of C1216W and C12*** is totally same as that of the predicate device.
- The technological characteristic differences between C1216W (C12***) and RadiForce RX1270 do not affect the safety and effectiveness, no new risk is raised.
- 0 Demonstrated by the bench tests, the display characteristics of C1216W and C12*** are equivalent to those of the 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).