UDE software is intended to display images from CT, MR, CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.

Device Description

UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. The device can be installed in iOS 9, 11, 12 and 13 version platform such as iPad /iPhone, but can't be installed in platforms other than iOS 9, 11, 12 and 13 version . The image display quality on iPad /iPhone will be almost the same as on iPad Pro when it is used for diagnosis purpose of CT, MR, US, XA and SC. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro. because the screen size of iPad Pro is larger than those of Apple® iPad/iPhone.

Main features of UDE are listed below

Receive, Store, Retrieve, Display, and Process Digital Images(CT, MR, US, CR, Full- Field . Mammography, XA,SC etc.)
· The displayed CT, MR, CR,, US,XA and SC images can be diagnosed by the trained physicians.
. The displayed CT, MR, CR, Full- Field Mammography, US, XA and SC images can be referred by the trained physicians. Mammography images are not for diagnostic use
· Communication log file
· Auto delete old images (FIFO)
· Overlay labels
· User Authentication
Display of Clinical Patient Data .
Distance Calculation
· layout adjustment (1×1, 2×1, 1×2, 2×2)
· Pan
Zoom
Window Level
· Cine Loop
Mammography hanging protocol

AI/ML Overview

Below is an analysis of the provided information, structured to address your request for acceptance criteria and study details.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it often contains less detailed information about performance studies compared to a full clinical study report. The analysis below extracts all available information and explicitly states when information is not present in the provided text.

Acceptance Criteria and Study Details for UDE

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets for device performance based on a specific study. Instead, it refers to the device meeting "the acceptance criteria referred to medical image software quality request" and passing "all tests successfully" based on the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document.

Performance Metric/Characteristic	Acceptance Criteria (Implicit/Referenced Standard)	Reported Device Performance
Software Quality	"Medical image software quality request"	Met and passed
Display Performance	AAPM Assessment of Display Performance for Medical Imaging Devices (2005)	All tests passed successfully
Substantial Equivalence	Equivalence to predicate device (EBM iDO Viewer K140399) in terms of safety and effectiveness, despite extended functionalities and different hardware.	Achieved (FDA clearance indicates this was met)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified for either the software verification/validation or the display performance testing.
Data Provenance:
- Software Verification/Validation: Unspecified, likely internal testing by the manufacturer (EBM Technologies Incorporated) in Taiwan (Republic of China).
- Display Performance: Unspecified, conducted by "a third party." No country of origin is specified for this third party.
- Retrospective or Prospective: Not specified. Given the nature of verification and validation testing, it would generally be considered prospective testing against design specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

No adjudication method is described. The document states that software verification and validation tests "had all met and passed" and display performance tests "had passed successfully." This suggests a direct comparison against established criteria or metrics rather than an expert adjudication process to establish ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly described or conducted for UDE to demonstrate improvement with AI vs. without AI assistance.
Effect Size: Not applicable as no such study was performed or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, for the referenced performance testing, the device was assessed on its own capabilities. The "display performance" testing evaluates the device's ability to render images according to a standard (AAPM document), which is a standalone evaluation of the device's display component. Similarly, "software verification testing and validation testing" are standalone evaluations of the software's functionality and adherence to quality requests.
The device itself, UDE, is a display and PACS (Picture Archiving and Communications System) software. Its primary function is to display images for a physician's diagnosis or reference. It is not an AI algorithm designed to interpret images or generate diagnoses automatically. Therefore, the "standalone" performance here refers to its ability to display medical images accurately, comply with software quality standards, and perform its stated functions.

7. Type of Ground Truth Used

Software Verification/Validation: The ground truth would be the pre-defined software requirements and design specifications that the software is intended to meet, and potentially expected outputs for given inputs.
Display Performance: The ground truth would be the criteria and metrics defined in the "AAPM Assessment of Display Performance for Medical Imaging Devices (2005)" document, which specify the expected performance characteristics of a medical imaging display.

8. Sample Size for the Training Set

Not applicable. UDE is a medical image display and PACS software, not a machine learning or AI model that requires a "training set" in the conventional sense of supervised learning. The software is developed based on engineering principles and tested against specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated in point 8, there is no "training set" for this type of software.

Summary

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October 5, 2020

Image /page/0/Picture/1 description: The image shows 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.

EBM Technologies, Inc. % Mr. John Su Regulatory Affairs Manager 5F., No. 516, Sec. 1, Neihu Rd. Taipei. Taiwan 11493 REPUBLIC OF CHINA

Re: K202292

Trade/Device Name: UDE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 27, 2020 Received: August 12, 2020

Dear Mr. Su:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K202292

Device Name UDE

Indications for Use (Describe)

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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K202292

5.1 Device Submitter

EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Taipei, Taiwan, Republic of China Phone: 886 2 8751 4567 Fax: 886 2 8751 3300 Contact Person: John Su Regulation Affairs Manager Tel: 808. 397.6809 john@ebmtech.com

5.2 Device Name

Device Trade Name: UDE Device Class : Class 2 Product Code : LLZ Regulation name and number: Picture Archiving and Communications System , 21 CFR 892.2050

5.3 Substantially Equivalent (predicate) device(s)

Device Trade Name: EBM iDO Viewer 510(k) Number: K140399 Device Class : Class 2 Product Code : LLZ Regulation name and number: Picture Archiving and Communications System , 21 CFR 892.2050 Manufacturer: EBM Technologies Incorporated

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5.4 Device Description:

Main features of UDE are listed below

Receive, Store, Retrieve, Display, and Process Digital Images(CT, MR, US, CR, Full- Field . Mammography, XA,SC etc.)
· The displayed CT, MR, CR,, US,XA and SC images can be diagnosed by the trained physicians.
. The displayed CT, MR, CR, Full- Field Mammography, US, XA and SC images can be referred by the trained physicians. Mammography images are not for diagnostic use
· Communication log file
· Auto delete old images (FIFO)
· Overlay labels
· User Authentication
Display of Clinical Patient Data .
Distance Calculation
· layout adjustment (1×1, 2×1, 1×2, 2×2)
· Pan
Zoom
Window Level
· Cine Loop
Mammography hanging protocol

5.5 Indication for Use:

UDE software is intended to display images from CT, MR, CR, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.

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5.6 Technical characteristics

UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. It has functions related to the medical image presentation and processing. These functions can help the trained physician to perform the medical images review and diagnosis if environment lighting condition has been evaluated and in opportune setting.

Device	Subject device	Predicate device	Comparison andExplanation ofDifferences
Topic	UDE	EBM iDO Viewer
510k number	N/A	K140399
Intended Use /Indications for Use	UDE software is intendedto display images fromCT, MR , CR, US, XAand SC for the trainedphysician 's diagnosis orreferring purpose. UDEprovides wireless andportable access tomedical images. It is notintended to be used as, orto replace, a fulldiagnostic workstation orsystem and should beused only when there isno access to aworkstation. This deviceis not to be used formammography diagnosis.	EBM iDO Viewer software isintended to display images fromCT/MR for the trained physician 'sdiagnosis or referring purpose.EBM iDO Viewer provideswireless and portable access tomedical images. It is not intendedto be used as, or to replace, a fulldiagnostic workstation or systemand should be used only when thereis no access to a workstation. Thisdevice is not to be used formammography.	The images displayed bysubject device have extendedto CR and Full-FieldMammography , US, XA andSC. It leads to the change ofintended use. It raises no newissues of safety oreffectiveness
Receive, Store,Retrieve, Display,and Process DigitalMedical Images	Yes	Yes	No difference
Display of ClinicalPatient Data WhenNo Access to aWorkstation	Yes	Yes	No difference
Distance Calculation	Yes	Yes	No difference
layout adjustment (1×1,2×1,1×2,2×2)	Yes	Yes	No difference
Window / Level	Yes	Yes	No difference
Zoom, Pan	Yes	Yes	No difference
User Authentication	Yes	Yes	No difference
Modality images fordiagnosis	CT, MRI, CR, US,XA,SC	CT, MRI	The images displayed bysubject device has extended toCR, US, XA, and SC. It raisesno new issues of safety oreffectiveness
Modality images forreference.Mammographyimages are not fordiagnostic use.	CT, MRI, CR, Full-FieldDigitalMammography, US,XA,SC	CT, MRI ,US, CR,XA,SC	The modalities connectedwith subject device hasextended to Full-FieldMammography. It raises nonew issues of safety oreffectiveness
Mammographyhanging protocol	Yes	No	Subject device has added anew image process functionwhich raise no new issues ofsafety or effectiveness
Communication logfile	Yes	No	Subject device has added anew image process functionwhich raise no new issues ofsafety or effectiveness
Auto delete oldimages (FIFO)	Yes	No	Subject device has added anew image process functionwhich raise no new issues ofsafety or effectiveness
Overlay labels	Yes	No	Subject device has added anew image process functionwhich raise no new issues ofsafety or effectiveness
Remote HandheldViewing	Yes	Yes	No difference
Operating Platform	Apple® iOS	Apple® iOS	No difference
HardwareRequirements	Apple® iPad Pro	Apple® iPad/iPhone	The hardware to be installed isdifferent. It raises no newissues of safety oreffectiveness
Screen technology	12.9"/11"TFT ColorLCD Panel	9.7"TFT Color LCD Panel(Apple® iPad)3.5"TFT Color LCD Panel(Apple® iPhone)	The screen size of iPad Pro islarger than those of Apple®iPad/iPhone. It raises no newissues of safety oreffectiveness
Screen resolution inpixels/square inch	264 ppi	264 ppi (Apple® iPad)326 ppi (Apple® iPhone)	The screen of iPad Pro has thesame resolution as that ofApple® iPad, but is differentthat of iPhone. It raises no newissues of safety oreffectiveness

Device Comparison between subject and predicate

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5.7 Performance data from non-clinical Testing

The software verification testing and validation testing based on IEC 62304 workflows have been performed by designed engineer or professional personnel. These testing include unit, integration and system tests. The test results of software verification and validation had all met and passed the acceptance criteria referred to medical image software quality request.

The non-clinical performance of display had been conducted according to the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by a third party to ensure high quality laboratory results. All tests had passed successfully.

5.8 Performance data from clinical Testing

Given the differences from the predicate device iDO Viewer (K140399), no clinical testing of the UDE software is necessary for this submission. The subject software is based on the cleared predicate. Moreover, bench testing results are showing adequate performance of the iPad Pro display used in combination with the UDE software.

5.9 Conclusion

Based on all above evidence, UDE described in this 510(K) is, in our opinion, substantially equivalent to the predicate devices.

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).