EBM iDO Viewer 1.2.1 software is intended to display images from CT. MR . CR. US. XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 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

EBM iDO Viewer 1.2.1 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 EBM PACS server. The device can be installed in iOS 5.0 or later version platform such as iPad, but can't be installed in platforms other than iOS 5.0 or later version . It will be almost the same image quality of CT, MR , US, XA and SC as displayed on iPad Pro when it is used for diagnosis purpose. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro.

AI/ML Overview

The provided text describes a 510(k) submission for the EBM iDO Viewer 1.2.1, a software device for displaying medical images. However, it does not contain detailed acceptance criteria or a comprehensive study design that proves the device meets specific performance criteria in the way a clinical trial for an AI/CADe device would.

The document discusses substantial equivalence to a predicate device and reports on non-clinical and "clinical" testing, but this is presented at a very high level and lacks the granular detail requested in the prompt.

Therefore, I cannot populate all the requested fields with specific, quantifiable data from the provided text. I will, however, extract what information is available and highlight where information is missing.

Here's an attempt to answer your request based on the provided text, with many fields marked as "Not provided in text":

Acceptance Criteria and Device Performance (Based on provided text)

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Non-clinical:
Software Verification & Validation (per IEC 62304 workflows)	"All met and passed the acceptance criteria referred to medical image software quality request."
Display Performance (per AAPM Assessment of Display Performance for Medical Imaging Devices (2005))	"All tests had passed successfully."
Clinical/Usability (Implied):
Acceptable image quality for diagnostic or remote reviewing use under intended conditions	"All three radiologists agree that the software and devices provide acceptable quality for diagnostic or remote reviewing use if the device is operated within the intended use."
Comfort with diagnostic mode	"They were comfortable with the diagnostic mode of EBM iDO Viewer 1.2.1 as a device."

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

Test Set Sample Size: "the same images" were read, but the number of images is Not provided in text.
Data Provenance:
- Country of origin of the data: Not provided in text (implied to be internal or from a partner, but no specific location beyond the company's Taiwan address for general operations).
- Retrospective or Prospective: Not provided in text.

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

Number of experts: Three (3)
Qualifications of experts: "three board-certified radiologists"

4. Adjudication method for the test set

Adjudication method: The text states, "All three radiologists agree that the software and devices provide acceptable quality..." This suggests consensus was sought or achieved regarding the qualitative assessment, but a formal adjudication method (e.g., 2+1, 3+1) for establishing a "ground truth" for quantitative performance metrics (like accuracy) is Not provided in text. This "clinical testing" appears to be more of a usability or qualitative assessment rather than a rigorous performance study.

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

MRMC Study: No. The device is a viewer, not an AI/CADe system. The "clinical testing" involved radiologists reading images on the device, but it was not a comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance.
Effect size: Not applicable / Not provided in text.

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

Standalone Performance: Not applicable for a viewer device. The device's primary function is to display images for human interpretation, not to provide an output/diagnosis independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "clinical testing" described seems to revolve around the radiologists' subjective agreement on the "acceptable quality" and their "comfort" with the device for diagnostic/reviewing purposes, rather than a quantifiable diagnostic ground truth for specific pathologies. Therefore, the ground truth was effectively expert subjective assessment of image quality and usability, not a clinical ground truth for disease presence/absence.

8. The sample size for the training set

This is a medical image viewer software, not an AI/ML algorithm that requires a training set in the typical sense for image interpretation. Therefore, a training set in this context is Not applicable / Not provided in text.

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

Not applicable (as per point 8).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2017

EBM Technologies, Incorporated % Mr. John Su Quality Manager 5f., No. 516, Sec. 1, Neihu Rd. Taipei, 114 Taiwan REPUBLIC OF CHINA

Re: K162285

Trade/Device Name: EBM iDO Viewer 1.2.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2016 Received: January 5, 2017

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara For

Robert 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) K162285

Device Name EBM iDO Viewer 1.2.1

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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510(k) Summary

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 Quality Manager Tel: 808. 397.6809 john@ebmtech.com

Date of Submission: Aug 15, 2016

5.2 Device Name

Device Trade Name: EBM iDO Viewer 1.2.1 Common/Classification Name: Picture Archiving and Communications System ( 21 CFR 892.2050, Product Code LLZ)

5.3 Substantially Equivalent (predicate) device(s)

Device Trade Name: EBM iDO Viewer 510(k) Number: K140399 Manufacturer: EBM Technologies Incorporated

5.4 Device Description:

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Pro.

5.5 Indication for Use:

EBM iDO Viewer 1.2.1 software is intended to display images from CT, MR , CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 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.

5.6 Technical characteristics

EBM iDO Viewer 1.2.1 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 EBM PACS 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.

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.

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5.8 Performance data from clinical Testing

Clinical testing were conducted by a panel of three board-certified radiologists reading the same images under different environmental lightning conditions. Under the usage condition requested by the indications for use, they were comfortable with the diagnostic mode of EBM iDO Viewer 1.2.1 as a device.

All three radiologists agree that the software and devices provide acceptable quality for diagnostic or remote reviewing use if the device is operated within the intended use.

5.9 Conclusion

Based on all above evidence, EBM iDO Viewer 1.2.1 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).