UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Device Description

UMD5-21B01 is a 5 mega pixels 21.3" color LCD display for viewing medical images including mammography and digital breast tomosynthesis. The resolution of the display is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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 UMD-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 Manage is a PC application for managing a group of displays.

AI/ML Overview

The provided text is a 510(k) summary for a medical display device (ACULA Technology Corp.'s UMD5-21B01). This document describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the nature of this document (a 510(k) summary for a display device) means that it does not include the type of detailed clinical study information typically associated with AI/ML-based medical devices or devices that generate diagnostic assessments needing complex acceptance criteria and ground truth establishment.

Instead, the performance data section focuses on bench tests related to the display's technical characteristics, such as spatial resolution, luminance, contrast, and DICOM conformance. These tests are conducted to ensure the display accurately presents medical images as per industry standards (like TG18 guidelines), which is a different kind of "acceptance criteria" than what would be applied to an AI algorithm predicting disease.

Therefore, many of the specific questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set size) are not applicable to this device and the information provided in this 510(k) summary.

I will fill in the table and address the relevant points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information does not exist for this type of device and submission.

Acceptance Criteria and Study Details for UMD5-21B01 Display Device

1. Table of Acceptance Criteria and Reported Device Performance

As this is a display device, the acceptance criteria relate to its imaging performance characteristics rather than diagnostic accuracy measures (like sensitivity/specificity for an AI algorithm). The document refers to "bench tests" and conformance to "TG18 guideline" and "DICOM GSDF." The table below summarizes the types of measurements performed, which serve as the "acceptance criteria" and the reported "performance" is that the device meets these standards (implicitly, as it gained clearance).

Acceptance Criteria (Bench Test Type)	Reported Device Performance (Implicitly Met for Clearance)
Measurement of spatial resolution (MTF)	Performed; Conforms to standards (e.g., TG18)
Measurement of pixel aperture ratio	Performed; Conforms to standards (e.g., TG18)
Maximum allowed number for each type of pixel defects/faults	Performed; Conforms to standards (e.g., TG18)
Visual check of presence or absence of miscellaneous artifacts	Performed; Conforms to standards (e.g., TG18)
Measurement of temporal response	Performed; Data provided by Innolux
Measurements of maximum and minimum luminance	Performed; Achievable values verified
Verification of DICOM GSDF conformance	Performed; Conforms to DICOM GSDF (TG18 guideline)
Measurement of angular dependency of luminance response	Performed; Conforms to standards (e.g., TG18)
Measurement of noise (NPS)	Performed; Conforms to standards (e.g., TG18)
Measurement of display reflections (specular, diffuse, glare)	Performed; Conforms to standards (e.g., TG18)
Measurement of small-spot contrast ratio	Performed; Conforms to standards (e.g., TG18)
Measurement of chromaticity non-uniformity characteristics	Performed; Conforms to standards (e.g., TG18)
Measurement of luminance non-uniformity characteristics	Performed; Conforms to standards (e.g., TG18)

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable in the context of image data for diagnostic performance. The "test set" here refers to the device itself undergoing various physical and photometric measurements. Typically, a single production unit or a small number of units are tested to confirm design specifications.
Data Provenance: Not applicable. The tests are bench tests of the display hardware and its performance, not studies on image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI algorithms (e.g., disease presence) is not established for a display device. The "ground truth" for these tests are objective physical measurements against established industry standards (like TG18 guidelines).

4. Adjudication method for the test set

Not applicable. As no human interpretation of images for ground truth labeling is involved, there is no need for adjudication.

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 a display device, not an AI-assisted diagnostic tool. No MRMC study was performed or needed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a display device, not a standalone algorithm. The "performance" is its ability to accurately display images, which is assessed through bench testing.

7. The type of ground truth used

Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for the device's technical performance is defined by established industry standards, measurement protocols (e.g., AAPM TG18), and physical metrology.

8. The sample size for the training set

Not applicable. This is a display device, not an AI system that undergoes training.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ACULA Technology Corp. % Tzu-Wei Li Third Party Contact Center For Measurement Standards Of Industrial Bldg. 16, 321 Kuang Fu Rd.sec2 HSINCHU. TAIWAN

June 13, 2024

Re: K241499

Trade/Device Name: 21.3" 5MP Color LCD Display UMD5-21B01 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 28, 2024 Received: May 28, 2024

Dear Tzu-Wei Li:

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 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,

Jessica Lamb

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K241499

Device Name

21.3" 5MP Color LCD Display UMD5-21B01

Indications for Use (Describe)

UMD5-21B01 is indicated for use in displaying radiological images (including full-field 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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K241499 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: Apr. 22, 2024

II. DEVICE

Name of Device: 21.3" 5MP Color LCD Display UMD5-21B01 Common or Usual Name: UMD5-21B01 Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) Regulatory Class: II Product Code: PGY

III. PREDICATE DEVICE

510(k) Number: K200864 Model Name: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ Applicant: Shenzhen Beacon Display Technology Co., Ltd. Common Name: 5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The UMD5-21B01 is 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The comparison table below provides information to support the substantial equivalence between the proposed device Color LCD Display UMD5-21B01 and predicate device Color LCD Display C53S+, C53SP+ (K200864) in terms of intended use, application and technological characteristics.

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ComparisonItem	Proposed Device21.3" 5MP Color LCDDisplay UMD5-21B01	Predicate Device21.3" 5MP Color LCDDisplay C53S+,C53SP+	Explanation ofDifferences
510(k) number	Unknown	K200864
Intended Use	The UMD5-21B01 isindicated for use indisplaying radiologicalimages (includingfull-field digitalmammography anddigital breasttomosynthesis) forreview, analysis, anddiagnosis by trainedmedical practitioners	The 5MP Color LCDMonitors C53S+,C53SP+ and 5MPMonochrome LCDMonitors G53S+,G53SP+ are intendedto be used indisplaying andviewing medicalimages for diagnosisby trained medicalpractitioners orcertified personnel.They're intended tobe used in digitalmammographyPACS, digital breasttomosynthesis andmodalities includingFFDM	Same
ScreenTechnology	TFT Color LCD Panel(IPS)	TFT Color LCD Panel(IPS)	Same
Viewing angle	CR>10Horizontal: Typ.178Vertical: Typ.178	CR>10Horizontal: Typ.178Vertical: Typ.178	Same
Resolution	5MP (2048 x 2560)	5MP (2048 x 2560)	Same
Aspect ratio	4:5	4:5	Same
Display area	Horizontal: 337.92mmVertical: 422.4mm	Horizontal: 337.92mmVertical: 422.4mm	Same
Pixel pitch	Horizontal: 0.165mmVertical: 0.165mm	Horizontal: 0.165mmVertical: 0.165mm	Same
Response time(Typ.)	25ms (On/Off)	25ms (On/Off)	Same
Maximumluminance	Min. 920cd/m2Typ. 1,150cd/m2	Min. 920cd/m2Typ. 1,150cd/m2	Same
DICOMcalibratedluminance	500cd/m2	500cd/m2	Same
Contrast ratio	Min. 1600:1Typ. 2000:1	Min. 1600:1Typ. 2000:1	Same
Backlighting	LED	LED	Same
GrayscaleTones	10-bit (DisplayPort):1.073 billion1024 from a palette of16,384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones	10-bit (DisplayPort):1.073 billion1024 from a palette of16,384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones	Same
Luminancenon-uniformityCompensation	-	-	Same
Input VideoSignals	DVI-D x1DisplayPort x1	DVI-D x1DisplayPort x1	Same
ScanningFrequency	Landscape:Horizontal: 104.852KHzVertical: 50Hz	Landscape:Horizontal: 104.852KHzVertical: 50Hz	Same
Dot Clock	285 MHz	285 MHz	Same
PowerRequirements	AC100-240V,50/60Hz	DC 12V, 6.67A	Different betweenbuilt-in power supplyand built-out powersupply
PowerConsumption /Save Mode	85WLess than 1W	80WLess than 5W	In comparison withpredicate device,UMD5-21B01maximum power ishigher, but itconsumes lesspower in standby
			mode.
PowerManagement	DVI DPMS,DisplayPort 1.2a	DVI DPMS,DisplayPort 1.2	Different spec.version betweenDisplayPort 1.2 andDisplayPort 1.2a
QC Software	AcuCal	Beacon MonitorManage	Different design
Sensors	Built-in Front SensorBuilt-in ambient LightSensorBuilt-in BacklightSensor	Built-in Front Sensor(Only for C53SP+)Built-in ambient LightSensorBuilt-in BacklightSensor	Same
USB Ports /Standard	1 upstream,3 downstream / Rev.2.0	1 upstream,2 downstream / Rev.2.0	In comparison withpredicate device,UMD5-21B01 hasone moredownstream USBPort for service use
Dimensionsw/o Stand(W x H x D)	359 x 458 x 75.9 mm	395.3 x 549.6/629.6 x 234.8 mm	Different industrialdesign

UMD5-21B01 510(k) Submission

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According to the above table, UMD5-21B01 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.

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VII. PERFORMANCE DATA

The performance data bench tests below were performed on the UMD5-21B01 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 quideline
Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
Measurement of noise expressed as noise power spectrum (NPS)
Measurement of display reflections including specular, diffuse and glare components
Measurement of small-spot contrast ratio
Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline

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XIII. CONCLUSIONS

After analyzing all testing data and comparing it with the predicated device, it can be concluded that UMD5-21B01 is substantially equivalent to the predicate device (K200864) with respect to technological characteristic, 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 between the devices do not affect safety or effectiveness.

Regulation Number and Section

§ 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).