(235 days)
The 3MP Color LCD Display UMD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
UMD3-21B01 (MD3-21B01) is a 3 mega pixels 21.3" color LCD display for viewing medical images, not including mammography. The resolution of the display is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.
Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.
AcuCal, a general name for the calibration and quality control functions of MD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Mange is a PC application for managing a group of displays.
The provided text describes a 510(k) submission for a medical display device, the 21.3" 3MP Color LCD Display UMD3-21B01 (MD3-21B01). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML algorithm meets acceptance criteria through a specific study design (e.g., MRMC).
The document is about a display device, not an AI/ML algorithm. Therefore, many of the requested criteria (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study, standalone algorithm performance) are not applicable to the type of device described.
However, I can extract information related to the performance data and the "acceptance criteria" as they apply to a display device being cleared for diagnostic imaging.
Here's an interpretation of the performance data that can be framed as "acceptance criteria" for a medical display device, based on the provided text:
Acceptance Criteria and Reported Device Performance for a Medical Display Device
Since the device is a medical display, the acceptance criteria relate to its image quality and conformance to standards relevant for medical imaging. The performance data section describes tests performed to ensure the display meets these expectations.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list "acceptance criteria" as pass/fail thresholds for each test, but rather describes the measurements taken and implies that the device performed adequately to demonstrate substantial equivalence. The predicate device's specifications act as an implicit benchmark for many of these performance characteristics.
| Acceptance Criterion (Test Performed) | Reported Device Performance (UMD3-21B01) | Comparison/Context (Predicate Device) |
|---|---|---|
| Measurement of spatial resolution (MTF) | Performed as per "Guidance for Industry..." | Not explicitly stated for predicate in comparison table, but general expectation for diagnostic displays. |
| Measurement of pixel aperture ratio | Performed as per "Guidance for Industry..." | Not explicitly stated for predicate. |
| Maximum number allowed for each type of pixel defects/faults | Addressed as per "Guidance for Industry..." | Not explicitly stated for predicate. |
| Visual check of miscellaneous artifacts (TG18 guideline) | Assessed as per AAPM TG18 guideline | Not explicitly stated for predicate. |
| Measurement of temporal response | Performance data provided by Innolux (LCD panel vender) | Predicate device's response time is 25ms (On/Off), proposed device is also 25ms (On/Off). |
| Measurements of maximum and minimum luminance | Performed as per "Guidance for Industry..." | Predicate device's brightness (typical) is 1,000cd/m2, recommended brightness for is 500cd/m2. Proposed device matches these specifications. |
| Verification of DICOM GSDF conformance (TG18) | Verified as specified in TG18; tone curve is DICOM compliant. | Not explicitly stated for predicate in comparison table, but implicit for a medical display. "AcuCal-Pro" (firmware) on proposed device ensures DICOM conformance, |
| predicate uses "Beacon Monitor Manage". Both achieve appropriate calibration for medical image viewing. | ||
| Measurement of angular dependency of luminance response | Performed in horizontal, vertical, and diagonal directions | Predicate device's viewing angle is Horizontal: Typ.178, Vertical: Typ.178. Proposed device matches this. |
| Measurement of chromaticity non-uniformity (TG18) | Performed as specified in TG18 guideline | Display type is Color (IPS) for both, so uniformity is expected. |
| Contrast Ratio (typical) | 1500:1 | Predicate device also 1500:1. |
| Display Colors | 10-bit (DisplayPort): 1.073 billion (1024 from a palette of 16,384 tones), 8-bit (DVI): 16.77 million (256 from a palette of 16,384 tones) | Predicate device has identical display color capabilities. |
| Quality-control Software | AcuCal (AcuCal-Pro firmware, AcuCal Manage PC app) performs luminance calibration and quality control (DICOM conformance). | Predicate device uses "Beacon Monitor Manage". Both serve similar quality control functions, "different design scheme" but no impact on safety/effectiveness. |
| Sensors | Backlight sensor, Integrated front sensor, Ambient light sensor | Predicate device has identical sensors. |
| Luminance calibration tools | Integrated optical sensor, External optical sensor, Calibration software: AcuCal-Pro | Predicate device has Integrated optical sensor, External optical sensor, Calibration software: Beacon Monitor Manage. "Different design scheme" but no impact on safety/effectiveness. |
2. Sample size used for the test set and the data provenance
The document does not detail a "test set" in the context of an AI/ML algorithm. Instead, it describes performance tests conducted on the physical display device itself. The provenance of this performance "data" would be the manufacturing site (Taiwan, where ACULA Technology Corp. is located) and the testing procedures applied to the specific model (UMD3-21B01/MD3-21B01). It is device performance testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the submission is for a medical display, not an AI/ML diagnostic tool that requires ground truth established by experts. The "ground truth" for a display is its physical performance characteristics measured against industry standards (e.g., DICOM GSDF, AAPM TG18).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for an AI/ML algorithm's performance on a dataset, not a display's physical performance verification.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the display's performance is established by physical measurement standards and industry guidelines, such as the DICOM GSDF (Grayscale Standard Display Function) and AAPM Task Group 18 (TG18) guidelines. These are objective, quantifiable standards for display performance in medical imaging.
8. The sample size for the training set
Not applicable. The device is a display, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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May 21, 2024
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ACULA Technology Corp Sheng-Sung Jian Director of R&D 11, Alley 21, Lane 20, Rd. Dashing, Luchu Dist. TAOYUAN, 33862 TAIWAN
Re: K233336
Trade/Device Name: 21.3" 3MP Color LCD Display UMD3-21B01 (MD3-21B01) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: April 12, 2024 Received: April 16, 2024
Dear Sheng-Sung Jian:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Samul 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
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Indications for Use
510(k) Number (if known)
Device Name
21.3" 3MP Color LCD Display UMD3-21B01(MD3-21B01)
Indications for Use (Describe)
The 3MP Color LCD Display UMD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K233336
510(k) Summary
I. SUBMITTER
ACULA Technology Corp. Address: No. 11, Alley 21, Lane 20, Rd. Dashing Luchu Dist., Taoyuan City, Taiwan 33862 Phone: +886-3-3135577 Fax: +886-3-3233355 Contact Person: Sheng-Sung Jian Email: SSJian@acula.com.tw Date Prepared: September 19, 2023
DEVICE ==
Name of Device: 21.3" 3MP Color LCD Display UMD3-21B01 (MD3-21B01) Common or Usual Name: UMD3-21B01 (MD3-21B01) Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) Regulatory Class: II Product Code: PGY
III. PREDICATE DEVICE
510(k) Number: K201211 Model Name: C32S+, C32SP+ Applicant: Shenzhen Beacon Display Technology Co., Ltd. Common Name: 3MP LCD Monitors C32S+, C32SP+ Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2
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IV. DEVICE DESCRIPTION
UMD3-21B01 (MD3-21B01) is a 3 mega pixels 21.3" color LCD display for viewing medical images, not including mammography. The resolution of the display is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.
Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.
AcuCal, a general name for the calibration and quality control functions of MD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Mange is a PC application for managing a group of displays.
- ** UMD3-21B01 and MD3-21B01 refer to the same monitor. UMD3-21B01 is registered trade name for Acula Technology Corporation. MD3-21B01 is the model name for Acula Technology Corporation.
V. INDICATIONS FOR USE
The 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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The comparison table below provides information to support the substantial equivalence between the proposed device Color LCD Display UMD3-21B01 (MD3-21B01) and predicate device Color LCD Display C32S+, C32SP+ (K201211) in terms of intended use, application and technological characteristics.
| ComparisonItem | Proposed Device21.3" 3MP Color LCDDisplay UMD3-21B01(MD3-21B01) | Predicate Device 21.3"3MP Color LCDDisplay C32S+,C32SP+ | Explanation ofDifferences |
|---|---|---|---|
| 510(k) number | Unknown | K201211 | |
| Intended Use | The 3MP Color LCDDisplay UMD3-21B01(MD3-21B01) isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.The display is notintended formammography. | The 3MP Color LCDMonitors C32S+,C32SP+ are indicatedfor use in displayingradiological images forreview, analysis, anddiagnosis by trainedmedical practitioners.The displays are notintended formammography. | Same |
| Displaytechnology | Color (IPS) | Color (IPS) | Same |
| Screen size | 54.1cm / 21.3"Aspect ratio: 3:4 | 54.1cm / 21.3"Aspect ratio: 3:4 | Same |
| Viewing angle | Horizontal: Typ.178Vertical: Typ.178 | Horizontal: Typ.178Vertical: Typ.178 | Same |
| Native resolution | 1536 x 2048 | 1536 x 2048 | Same |
| Viewable imagesize | Horizontal: 324.86mmVertical: 433.15mm | Horizontal: 324.86mmVertical: 433.15mm | Same |
| Pixel pitch | Horizontal: 0.2115mmVertical: 0.2115mm | Horizontal: 0.2115mmVertical: 0.2115mm | Same |
| Response time(typical) | 25ms (On/Off) | 25ms (On/Off) | Same |
| Brightness(typical) | 1,000cd/m2 | 1,000cd/m2 | Same |
| Recommendedbrightness for | 500cd/m2 | 500cd/m2 | Same |
| Contrast ratio(typical) | 1500:1 | 1500:1 | Same |
| Backlight type | LED | LED | Same |
| Display colors | 10-bit (DisplayPort):1.073 billion 1024 from a palette of 16,384 tones8-bit(DVI): 16.77 million 256 from a palette of 16,384 tones | 10-bit (DisplayPort):1.073 billion 1024 from a palette of 16,384 tones 8-bit(DVI): 16.77 million 256 from a palette of 16,384 tones | Same |
| Input VideoSignal | DVI-D (dual link) x1DisplayPort x1 | DVI-D (dual link) x1DisplayPort x1 | Same |
| ScanningFrequency (H, V) | 31 - 97 kHz/59 - 61 Hz | 31 - 97 kHz/59 - 61 Hz | Same |
| Video bandwidth | DVI: 216 MHzDisplayPort: 216 MHz | DVI: 216 MHzDisplayPort: 216 MHz | Same |
| PowerRequirements | AC100-240V,50/60Hz | DC 12 V / 6.67 A | Difference betweenbuilt-in powersupply and built-outpower supply |
| Maximum PowerConsumption | 80W | 80W | Same |
| In comparison with | |||
| Power savemode | Less than 1W | Less than 5W | predicate device,UMD3-21B01(MD3-21B01)consumes lesspower in powersave mode. |
| PowerManagement | DVI DMPM,DisplayPort 1.2a | DVI DMPM,DisplayPort 1.2 | Same |
| Quality-controlSoftware | AcuCal | Beacon MonitorManage | Different designscheme |
| Backlight sensorIntegrated front sensorAmbient light sensor | Backlight sensorIntegrated front sensorAmbient light sensor | ||
| Sensors | Same | ||
| Luminancecalibration tools | -Integrated opticalsensor-External optical sensor-Calibration software:AcuCal-Pro | -Integrated optical sensor-External optical sensor-Calibration software:Beacon Monitor Manage | Different designscheme |
| USB Ports | 1 upstream, 3downstream / Rev. 2.0 | UpstreamUSB 2.0: Type-B x 1 | In comparison withpredicate device,UMD3-21B01(MD3-21B01)has one moredownstream USBPort for service use |
| Brightnessstabilization | Yes | Yes | Same |
| Digital uniformityequalizer | Yes | Yes | Same |
| Net weight | 10.9 kgs | 9.5 kgs | Different industrialdesign |
| Hole Spacing(VESA Standard) | 100 x 100mm | 100 x 100mm | Same |
| Dimensionsw/o Stand(W x H x D) | 354.2 x 472.7 x 78.8mm | 369 x 220 x 511.5 ~596.15 mm | Different industrialdesign |
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According to the above table, UMD3-21B01 (MD3-21B01) is a medical device which has the same intended use as the predicate device. The difference in the above statement does not change the intended use. As a result, both devices have fundamentally the same intended use.
VII. PERFORMANCE DATA
The performance tests below were performed on the UMD3-21B01 (MD3-21B01) following the instructions in "Guidance for Industry and Food and Drug Administration Staff: Display Devices for Diagnostic Radiology":
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- Measurement of pixel aperture ratio
- The maximum number allowed for each type of pixel defects/faults ●
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- Measurement of temporal response Performance data (provided by Innolux, LCD panel vender)
- Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values
- Verification of the conformance to DICOM GSDF as specified in TG18 ● UMD3-21B01 (MD3-21B01) 510(k) Submission
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guideline
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
XIII. CONCLUSIONS
After analyzing all testing data and comparing it with the predicated device, it can be concluded that UMD3-21B01 (MD3-21B01) is substantially equivalent to the predicate device (K201211) with respect to technological characteristic, application and intended use. Some of the technological characteristics of UMD3-21B01 (MD3-21B01) are different from the predicate device, but they do not affect the safety and effectiveness, so no new risk is raised.
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 between the devices do not affect safety or effectiveness.
§ 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).