BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS.

Device Description

BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.

AI/ML Overview

This document describes the BR-ABVS Viewer 1.0, a standalone software device intended to assist physicians in visualizing and analyzing 3-D breast ultrasound images generated by the Siemens ACUSON S2000 Automated Breast Volume Scanner (ABVS).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a comprehensive table comparing multiple performance metrics. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device (ABVS Workplace, K092067) in terms of image loading and overall functionality.

Feature / Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
3-D Image Loading	Ability to accurately load and display 3-D breast ultrasound images.	Demonstrated accurate 3-D image loading during comparison testing with the predicate device.
Image Visualization	Ability to visualize 3-D image volumes by axial, sagittal, and coronal planes.	Provides visualization of any orientation of 3-D image (axial, sagittal, coronal) according to anatomical coordinate system.
Image Size Accuracy	Accurate representation of image size.	Actual image size obtained by considering spacings of three axes specified in standard DICOM tags.
Overall Functionality	Similar intended use, technological characteristics, and major functionality to the predicate.	"The intended use, technological characteristics, and major functionality of BR-ABVS Viewer 1.0 are similar to the predicate device..."
Safety and Effectiveness	No new issues of safety or effectiveness introduced compared to the predicate.	"...no new issues of safety or effectiveness are introduced by using this device." "The performance data generated... demonstrates that our software device is as safe and effective, as compared to the predicate."

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

Sample Size: "An actual clinical image generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014 was used..." This implies a sample size of one clinical image.
Data Provenance: The image was "generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014." The country of origin is not explicitly stated, but the manufacturer (TaiHao Medical Inc.) is based in Taiwan. The image is retrospective as it was generated prior to the study.

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

The document does not mention the use of experts to establish ground truth for the test set or their qualifications. The performance study appears to be a technical comparison of image loading and visualization between the subject device and the predicate device, rather than a clinical accuracy study requiring expert human annotation/diagnosis as ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no indication of multiple readers, consensus, or adjudication in establishing ground truth for the single image used in the comparison. The comparison focused on whether the device could load and display the image as expected, similar to the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a technical comparison of image loading and display, using a single image, between the subject device and a predicate device. There is no mention of human readers evaluating performance "with AI vs. without AI assistance."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance testing described is primarily a standalone assessment of the BR-ABVS Viewer 1.0's technical capabilities (image loading, visualization, size accuracy) compared to the predicate device. While the device is intended "to assist the physician," the described study itself evaluates the software's inherent ability to process and display images without explicitly measuring the human-in-the-loop performance or diagnostic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the described performance study appears to be the expected rendering and technical specifications of the 3-D breast ultrasound image when loaded and displayed. The comparison was against the functionality of a legally marketed predicate device (ABVS Workplace) for properties like 3-D image loading, multi-planar visualization, and accurate image sizing based on DICOM tags. It is not an "expert consensus," "pathology," or "outcomes data" type of ground truth.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is described as a "Viewer" and not as an AI/ML-based diagnostic algorithm that requires a training set in the typical sense for learning patterns from data. Its function is to visualize existing 3-D images.

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

Not applicable. As described in point 8, there is no mention or indication of a training set as would be required for machine learning models. The device's primary function is image visualization based on known technical specifications (e.g., DICOM standards).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo 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 15, 2016

TaiHao Medical, Inc. % Chiu S. Lin, Ph.D. President LIN & ASSOCIATES, LLC 9223 Cambridge Manor Court POTOMAC MD 20854

Re: K151075

Trade/Device Name: BR-ABVS Viewer 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 15, 2015 Received: December 15, 2015

Dear Dr. Lin:

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) K151075

Device Name BR-ABVS Viewer 1.0

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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5. 510(k) Summary of Safety and Effectiveness Information

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92

5.1. Identification of Submitter:

Submitter: TaiHao Medical Inc.

Address: 7F., No.410, Sec. 5, Zhongxiao E. Rd., Xinyi Dist., Taipei City 110, Taiwan (R.O.C.)

Phone: 886-2-2858-2357

Contact: HSIN HUNG (Simon) LAI

Title: President

Phone: 886-2-2858-2357

Email: simonlai@taihaomed.com

Manufacturer: TaiHao Medical Inc.

US Agent and Contact: Chiu S. Lin, Ph.D.

LIN & ASSOCIATES, LLC

Address: 9223 Cambridge Manor Court

Potomac, MD 20854 U.S.A.

Phone: (0) 301-591-3895

Email: cslin@lin-associates.com

Date prepared: April 8, 2015

5.2. Identification of Product

Device Trade Name: BR-ABVS Viewer 1.0

Common and Usual Name: Ultrasound Image Display Device

Device Classification Name: Picture Archiving and Communication System

Regulation Number: 21 CFR 892.2050

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Classification Product Code: LLZ

Classification: Class II Radiology Devices Classification Panel:

Manufacturer: TaiHao Medical Inc.

5.3. Predicate Device

This subject software medical device is substantially equivalent to the devices listed below:

Model: ABVS Workplace

Manufacturer: Siemens Medical Solutions

510(k) Number: K092067, cleared on September 18, 2009

5.4. Device Description

BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.

5.5. Indications for Use

BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS.

5.6. Comparison with Predicate Devices

BR-ABVS Viewer 1.0 is substantially equivalent to ABVS Workplace with a general intended use for viewing and analyzing ultrasound image data to physicians. Minor technological characteristics differences do not raise any new questions of safety and effectiveness.

The comparison table between our device and the predicate devices is provided below:

		BR-ABVS Viewer 1.0	ABVS Workplace
--	--	---------------------------	-----------------------

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Manufacturer	TaiHao Medical Inc.	Siemens Medical Solutions
510(k) Number	K151075	K092067
Device Common Name	Picture archiving andcommunications system	Picture archiving andcommunications system
Regulation Number	21 CFR 892.2050	21 CFR 892.2050
Regulation Name	Picture archiving andcommunications system	Picture archiving andcommunications system
Product Code	LLZ	LLZ
Indications for Use	BR-ABVS Viewer 1.0 isintended as a standalonesoftware device installed on astandalone windows-basedcomputer to assist thephysician to visualize anyorientation of three-dimensional (3-D) breastultrasound images generatedby Siemens ACUSON S2000Automated Breast VolumeScanner, ABVS (cleared inK081148). The device isindicated for use to assist thephysicians in their review andanalysis of the 3-D breastultrasound images generatedby ABVS.	ABVS Workplace is intendedto display ultrasound imagesof the breast acquired from B-mode imaging using anautomatic or handheldscanning linear transducer.The images may be reviewedand analyzed by thephysician. The ABVSWorkplace is indicated for useas an adjunct tomammography. The ABVSWorkplace is not intended tobe used as a replacement forscreening.
Functional Capability ofImage Processing	BR-ABVS Viewer 1.0provides visualization of anyorientation of 3-D image.	The ABVS Workplace appliespost-processing algorithmsbased on the nipple location.A reverberation removalalgorithm determines tissuecontact areas. This suppressesreverberation artifacts fromthe non-contact area. Aproprietary adaptive nippleshadow reduction toolanalyzes the data volume andenhances structures in theretroareolar area to improvevisualization of this typicallychallenging anatomicalregion.
Software Design	Image processing techniques	Same
Platform	Window-based	Same
Operating System	Standard PC or review station	Own workstation, whichincludes IT hardware and pre-installed software
Clinical Application	As an adjunct tomammography screening	Same
Image Type to Be Processedby The Device	Automated breast ultrasoundimages generated by SiemensACUSON S2000 AutomatedBreast Volume Scanner,ABVS (cleared in K081148).	Same
Image Format	DICOM images acquired onSiemens ACUSON S2000Automated Breast Volume	Same
	Scanner, ABVS
Automatically GeneratingReport	Yes	Yes
Performance Testing toSupport SE Determination	Results from SoftwareValidation Report of BR-ABVS Viewer 1.0	From the 510(k) Summarythat is available on the FDAdatabase, it appears that nodata from performance testingwere submitted.

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5.7. Performance Standards

No applicable FDA performance standards have been issued.

5.8. Software

Software development for BR-ABVS Viewer 1.0 follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards. Appropriate steps have been taken to control all identified risks for this type of image viewing and quantification device.

5.9. Summary of Performance Data to Support Substantial Equivalence

BR-ABVS Viewer 1.0 displays the 3-D image volume by axial, sagittal, and coronal plane according to the anatomical coordinate system to provide an overall observation. The actual image size is obtained by considering the spacings of three axes specified in the standard DICOM tags. TaiHao Medical Inc. has conducted a performance study to validate and assess the performance of BR-ABVS Viewer 1.0 for its-intended use. An actual clinical image generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014 was used to do the comparison testing between BR-ABVS Viewer 1.0 and the predicate (ABVS Workplace, K092067) in terms of substantial equivalence in 3-D image loading.

5.10. Conclusions

The intended use, technological characteristics, and major functionality of BR-ABVS Viewer 1.0 are similar to the predicate device and no new issues of safety or effectiveness are introduced by using this device. The performance data generated, as described, demonstrates that our software device is as

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safe and effective, as compared to the predicate. Therefore we believe BR-ABVS Viewer 1.0 is Substantially Equivalent to the predicate device.

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).