(89 days)
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography. With built-in multi-display modes, the monitor facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
The provided text describes the 510(k) summary for the Shenzhen Beacon Display Technology Co., Ltd.'s 6MP Color LCD Monitor (C61W+). It outlines the device's technical specifications and compares it to a predicate device, the EIZO Corporation's 6MP Color LCD Monitor, RadiForce RX650 (K134002).
However, this document does not contain information related to an AI/ML-based medical device study. The device in question is a medical display monitor, and the "acceptance criteria" and "study" described are focused on verifying its display performance characteristics (e.g., DICOM conformance, luminance, chromaticity, pixel defects) against established standards (AAPM TG18 guideline) and demonstrating substantial equivalence to a predicate device.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria for an AI/ML product, as the provided text is about a display monitor and not an AI/ML medical device.
The document does mention performance tests done on the monitor to show its equivalence to the predicate device. Here's what can be extracted from the provided text about the monitor's performance testing:
Device: 6MP Color LCD Monitor (C61W+)
1. A table of acceptance criteria and the reported device performance:
The document doesn't present precise quantitative "acceptance criteria" in a table format for each test, but it states that "The test results showed that C61W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX650 except some items, each of which was determined that it would not affect observer's performance."
Here's a summary of the performance tests mentioned, which implicitly define the "acceptance criteria" as conforming to the specified standards or demonstrating equivalence to the predicate:
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (in accordance with AAPM TG18 guideline) | Conforms |
| Measurement of luminance non-uniformity characteristics (in accordance with TG18 guideline) | Equivalent to predicate; "would not affect observer's performance" |
| Measurement of chromaticity non-uniformity characteristics (in accordance with TG18 guideline) | Equivalent to predicate; "would not affect observer's performance" |
| Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of max luminance (in accordance with FDA Staff Guidance for Display Accessories for Full-Field Digital Mammography Systems) | Equivalent to predicate; "would not affect observer's performance" |
| Visual check for presence or absence of miscellaneous artifacts on the display screen (in accordance with TG18 guideline) | Equivalent to predicate; "would not affect observer's performance" |
| Maximum number allowed for each type of pixel defects/faults | Equivalent to predicate; "would not affect observer's performance" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The summary implies testing was done on the C61W+ monitor itself, likely one or a few units, rather than a "test set" of images or patient data.
- Data Provenance: Not applicable as it's a display monitor, not an AI/ML algorithm processing data. The tests are physical measurements and visual inspections of the monitor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of an AI/ML device, refers to disease presence/absence or other clinical labels. For a display monitor, the "ground truth" is adherence to technical specifications and established display standards (e.g., DICOM GSDF). The "experts" would be the engineers and technicians performing the measurements and visual checks, trained in display calibration and quality control. Their number and specific qualifications are not detailed in this summary.
4. Adjudication method for the test set:
- Not applicable. This concept is relevant for human-in-the-loop or expert consensus for AI/ML algorithm evaluation, not for physical device testing of a monitor.
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:
- No. This study type is for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for a medical display monitor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for AI/ML algorithms, not for a display monitor. The performance tests mentioned (DICOM conformance, luminance, etc.) are "standalone" in the sense they evaluate the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a medical display monitor is its adherence to industry standards for display quality, such as:
- AAPM TG18 guideline: For display performance assessment (DICOM GSDF conformance, luminance, chromaticity non-uniformity, artifacts).
- FDA Staff Guidance: Display Accessories for Full-Field Digital Mammography Systems: For specific chromaticity measurements.
- Internal specifications for pixel defects/faults.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm being trained for this device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm being trained for this device.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing Document Engineer 12F. Block B1. Nanshan Zhivuan. No.1001 Xuevuan Road Shenzhen, 518055 Cn
December 13, 2018
Re: K182291
Trade/Device Name: 6MP Color LCD Monitor (C61W+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: PGY Dated: September 25, 2018 Received: October 1, 2018
Dear Fu Ailing:
This letter corrects our substantially equivalent letter of November 20, 2018.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bargas
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
6MP Color LCD Monitor (C61W+)
Indications for Use (Describe)
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary K182291
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 26, 2018
2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: Shenzhen Beacon Display Technology Co., Ltd.
- Address: 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road, Nanshan District, Shenzhen, 518055 China
Contact Name: Fu Ailing +86-0755-33985118-5150 Telephone No.:
+86-0755-26995755 Fax No.:
Email Address: fuailing@beacon-display.cn
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
Trade Name/Model: 6MP Color LCD Monitor (C61W+) Common Name: 6 6MP Color LCD Monitor Classification Name: System, Image Processing, Radiological Requlation Number: 21 CFR 892.2050 Product code: LLZ Classification Panel: Radiology Device Class: II
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: EIZO Corporation, 6MP Color LCD Monitor, RadiForce RX650 has been cleared by FDA through 510(k) No. K134002 (Decision Date - January 31, 2014).
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5. Description of the Device [21 CFR 807.92(a) (4)]
C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography.
With built-in multi-display modes, the monitor facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
6. Intended Use [21 CFR 807.92(a)(5)]
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
| Monitor characteristics: | |
|---|---|
| Screen technology | 30", TFT, color, LCD screen, anti-glare, hard coating |
| Active area (H x V) | 654.4 x 408.6 mm |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Screen technology | 30", TFT, color, LCD screen, anti-glare, hard coating | |
|---|---|---|
| Active area (H x V) | 654.4 x 408.6 mm | |
| Pixel pitch | 0.197 mm (H) x 0.197mm (V) | |
| Resolution | 3,280 x 2,048 Pixels | |
| Contrast ratio | 950:1 (Typ.), 750:1 (Min.) | |
| Viewing angle (CR > 10) | Horizontal: 170° (Typ.) | |
| Vertical: 170° (Typ.) | ||
| Brightness | 800 cd/m² (Typ.) | |
| Refresh rate | 50 Hz | |
| Backlight | LED | |
| Lifetime of backlight | 50,000 hours | |
| Response time (Tr + Tf) | 30 ms (Typ.) | |
| Color support | 1.07 billion | |
| Power supply: | ||
| Power connection | Adapter (FSP, FSP220-KAAM1, Input: 100-240 V, 47-63 Hz; 2.5-1.2 A; Output: 24 V; 9.17 A, Max. 220 W).The approved adapter is considered as part of LCD Monitor. | |
| Line voltage | 24 V | |
| Current consumption | 9.0 A | |
| Power consumption | 160 W (Max.) | |
| Standby | < 5 W | |
| Inputs/outputs: | ||
| DVI input | Dual link DVI-D socket | |
| VGA input | For updating software | |
| USB | For connecting external PC | |
| DP input | Display Port socket | |
| Control and connection: | ||
| Front | 1 operation LED, 6 functional keys | |
| Back | 3 USB port 2 DVI connector 2 DP connector 1 VGA connector 1 Ground 1 DC socket 1 Power switch | |
| Mechanical characteristics: | ||
| Housing components | Plastic | |
| Ventilation openings | Natural heat radiation | |
| Connector panel | On rear panel, under cover | |
| Weight | 15.5 kg +/- 0.5 kg | |
| Dimensions (W x H x D) in mm | 718.5 x 549.1 ~ 629.1 x 251.4 mm (with stand) | |
| Climatic conditions: | ||
| Working temperature | 0°C ... 40°C | |
| Working humidity | 20% ... 80% Relative humidity, no condensation | |
| Transport and storagetemperature | -20°C ... 60°C | |
| Transport and storage humidity | 10% ... 90% Relative humidity, no condensation | |
| Air pressure | 700 - 1060 hPa | |
| Safety regulations: | ||
| Safety standards | IEC60601-1, EN60601-1ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1CAN/CSA-C22.2 NO. 60601-1:14 | |
| Protection class | Class III (adapter) | |
| Degree of protection | IP20 | |
| Conformity | CE according to MDD 93/42/EEC (Class I) | |
| Electromagnetic compatibility: | ||
| Noise immunity/interferenceemissions | IEC 60601-1-2, EN 60601-1-2 | |
| Dimension: | ||
| With packing (W x H x D) | 814 x 606 x 327 mm | |
| Weight: | ||
| Gross weight | 18 kg |
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8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | ComparisonItem | Proposed Device6MP Color LCD Monitor(C61W+) | Predicate Device6MP Color LCD Monitor(RX650) |
|---|---|---|---|
| 1 | Intended Use | The 6MP Color LCD Monitor(C61W+) is intended to beused in displaying and viewingdigital images for review andanalysis by trained medicalpractitioners. It does notsupport the display ofmammography images fordiagnosis. | This product is intended to beused in displaying andviewing digital images forreview and analysis bytrained medical practitioners.It does not support the displayof mammography images fordiagnosis. |
Table 1 Intended Use Comparison
8.2 Comparison table
Table 2 General Comparison
| ID | ComparisonItem | Proposed Device6MP Color LCDMonitor (C61W+) | Predicate Device6MP Color LCDMonitor(RX650) | Explanationof Difference | |
|---|---|---|---|---|---|
| 2 | Display Performance/Specifications | ||||
| 2.1 | Screentechnology | TFT Color LCD Panel(IPS) | TFT Color LCD Panel(IPS) | - | |
| 2.2 | Viewing angle(H, V) | H:170°, V:170° | H:176°, V:176° | Differentscreenprovided bythe differentmanufacturer | |
| 2.3 | Active screensize | 654.4 x 408.6 mm | 645.5 mm x 403.0 mm | Differentscreenprovided bythe differentmanufacturer | |
| 2.4 | Resolution | 6MP (3,280 x 2,048) | 6MP (3,280 x 2,048) | - | |
| 2.5 | Aspect ratio | 16:10 | 16:10 | - | |
| 2.6 | Pixel pitch | 0.197 mm x 0.197 mm | 0.197 mm x 0.197 mm | - | |
| 2.7 | Typicalluminance | 800 cd/m² | 800 cd/m² | - | |
| 2.8 | DICOMcalibratedluminance | 500 cd/m² | 400 cd/m² | Differentscreenprovided bythe differentmanufacturer | |
| 2.9 | Contrast ratio | 950:1 | 1000:1 | Differentscreenprovided bythe differentmanufacturer | |
| 2.10 | Backlighting | LED | LED | - | |
| 2.11 | Display Colors | From a palette of 68billion colors:- 10-bit (DisplayPort):1.07 billion colors(maximum) | From a palette of 68billion colors:- 10-bit (DisplayPort):1.07 billion colors(maximum)- 8-bit colors: 16.77million colors | - | |
| 2.12 | Luminancenon-uniformitycompensation | Digital UniformityEqualizer | Digital UniformityEqualizer | - | |
| 3 | Video Signal Input | ||||
| 3.1 | Input videosignals | DVI-D (dual link) x 2,DisplayPort x 2VGA x 1 | DVI-D (dual link) x 2,DisplayPort x 2(two inputs arerequired) | Differentdesignscheme | |
| 3.2 | ScanningFrequency(H, V) | 31.5 - 120 kHz/29 - 61Hz (VGA Text: 59 - 75Hz)Frame synchronousmode: 29.5- 30.5Hz,50 - 60 Hz | 31 - 129 kHz/29 - 61Hz (VGA Text: 69 - 71Hz)Frame synchronousmode: 29.5 - 30.5 Hz,59 - 61 Hz | - | |
| 4 | Power Related Specifications | ||||
| 4.1 | PowerRequirements | DC 24 V, 9.0 A | AC 100 - 120 V,200 - 240 V: 50/60 Hz | ThedifferencebetweenBuilt-in powersupply andBuilt-outpower supply | |
| 4.2 | PowerConsumption/Save Mode | 160 W/less than 5 W | 225 W/ Less than 6 W | Differentdesignscheme | |
| 4.3 | PowerManagement | DC Socket,Power switch | DVI DMPM,DisplayPort 1.1a | Differentdesignscheme | |
| 5 | Miscellaneous Features/Specifications | ||||
| 5.1 | QC software | Beacon MonitorManage | RadiCS | Differentdesignscheme | |
| 5.2 | Sensors | Backlight Sensor,Integrated FrontSensor,Ambient Light Sensor | Backlight Sensor,Integrated FrontSensor,Presence Sensor,Ambient Light Sensor | - | |
| 5.3 | USBPorts/Standard | 1 upstream,2 downstream / Rev.2.0 | 1 upstream,2 downstream / Rev.2.0 | - | |
| 5.4 | Dimensionsw/o stand(W x H x D) | 698 x 470 x 78 mm | 692 x 466 x 109 mm | Differenthousingdesign due tothe differentpanel size |
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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C61W+.
8.3 Performance Testing
The bench tests were performed on C61W+ as below.
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- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 quideline).
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance in accordance with Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k) Submissions.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 quideline.
- Maximum number allowed for each type of pixel defects/faults.
The test results showed that C61W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX650 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C61W+.
9. 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 C61W+ is totally same as that of the predicatedevice.
- The technological characteristics differences between C61W+ and RadiForce RX650 do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of C61W+ 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).