BR-FHUS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional ultrasound images along with the scanning paths and position information of probe that stored in the DICOM file in advance.

Device Description

BR-FHUS Viewer 1.0 is an electronic image review and reporting software program intended to operate on a windows-based computer. The device allows the review of previously recorded ultrasound examinations, which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally. The images are displayed on a computer monitor. The images can be reviewed individually or as a self-playing sequence. The software can adjust the speed of the playback. In addition, the device software allows the user to save the screenshots as DIOM-compatible files and generate electronic reports.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the BR-FHUS Viewer 1.0, based on the provided text:

Important Note: The provided document is a 510(k) summary for a Picture Archiving and Communications System (PACS) device. The primary purpose of such devices is to display and manipulate medical images, not to perform diagnostic analysis or provide AI-driven insights directly. Therefore, the "acceptance criteria" and "study" described here are related to the functional performance and safety of the imaging viewer itself, rather than diagnostic accuracy metrics typically associated with AI algorithms. The document explicitly states that the device is intended to "assist physicians with manipulation and analysis tools in reviewing breast ultrasound images," implying a role in image presentation and review, not automated diagnosis.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Implied/Stated)	Reported Device Performance
Functional Requirements	All functional requirements met.	"All functional requirements have been met."
Core Function Execution	Core functions execute as expected.	"Core functions execute as expected."
Validation to Specification	Validation results are within specification.	"The result of these tests demonstrate that BR-FHUS Viewer 1.0 validation is with in specification."
Intended Operation	Device functions as intended, and operation is as expected.	"In all instances, BR-FHUS Viewer 1.0 functioned as intended and the operation observed was as expected."
Safety and Effectiveness	Device is as safe and effective as predicate devices.	"BR-FHUS Viewer 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today." (Stated by manufacturer)
No New Safety/Effectiveness Issues	No new safety or effectiveness issues raised by features.	"The features provided by BR-FHUS Viewer 1.0 do not in themselves raise new concerns of safety or effectiveness."

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient cases. The testing was conducted using a "breast phantom." This suggests a limited, controlled environment rather than a broad patient data set.
- Data Provenance: Not applicable in the context of patient data for diagnostic accuracy. The data used for testing was generated from a "breast phantom" in a "simulated work environment."
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. Given the nature of the device as a viewer (not a diagnostic AI), external expert ground truth might not be the primary focus for its clearance. The "ground truth" here likely refers to the expected functional behavior of the software and accurate display of the phantom's ultrasound images.
Adjudication Method for the Test Set:
- Not applicable/Not described. The text indicates "internal procedures" and "trained personnel" performed the testing, implying a verification process against predefined functional expectations rather than an adjudication process of expert interpretations.
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:
- No, an MRMC comparative effectiveness study was not done. The BR-FHUS Viewer 1.0 is described as a "standalone software device... to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images." It is not an AI diagnostic or assistance tool in the sense of providing automated interpretations or improving human reader diagnostic accuracy. Its function is to facilitate image review.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of its function as a viewer. The performance data described is purely for the software's ability to display, manipulate, and analyze images as intended. It assesses the software itself against its functional specifications. It's a "standalone" performance assessment of the viewer's capabilities, not a diagnostic algorithm.
The Type of Ground Truth Used:
- Functional/Technical Ground Truth: The "ground truth" for this device appears to be its pre-defined functional requirements and expected display behavior. Testing against a "breast phantom" would verify that the images from the phantom are accurately displayed and that the manipulation tools work correctly. This is not a "diagnostic ground truth" like pathology for a lesion.
The Sample Size for the Training Set:
- Not applicable/Not mentioned. As the device is an image viewer and not an AI algorithm performing diagnostic tasks, there is no "training set" in the sense of machine learning.
How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 7).

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 and 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.

TaiHao Medical Inc. % Chiu S. Lin, Ph.D. President Lin & Associates, LLC 5614 Johnson Avenue BETHESDA MD 20817

Re: K171709

Trade/Device Name: BR-FHUS Viewer 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 31, 2017 Received: August 28, 2017

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 20, 2017

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.

Robert Ochs

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) K171709

Device Name BR-FHUS Viewer 1.0

Indications for Use (Describe)

BR-FHUS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spationing devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional images along with the scanning paths and position information of probe that stored in the DICOM file in advance.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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TaiHao Medical Inc.

The Leader of Medical Software

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

5.1. Identification of Submitter:

Submitter: TaiHao Medical Inc.

Address: 3F .- 8, No.100, Sec. 2, Heping E. Rd., Da'an Dist., Taipei City 106, Taiwan (R.O.C.)

Phone: 886-2-2736-5679

Contact: HSIN HUNG (Simon) LAI

Title: President

886-2-2736-5679 Phone:

Email: simonlai(@taihaomed.com

Manufacturer: TaiHao Medical Inc.

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

LIN & ASSOCIATES, LLC

Address: 5614 Johnson Avenue

Bethesda, MD 20817

Phone: (0) 301-591-3895

Email: cslin(@lin-associates.com

Date prepared: May 31, 2017

5.2. Identification of Product

Device Trade Name: BR-FHUS Viewer 1.0

Common and Usual Name: Picture Archiving and Communications System

Regulation Number: 21 CFR 892.2050

Classification Product Code: LLZ

Classification: Class II

Predicate Device: Tractus TissueMapper Reviewer Application (K123901)

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5.3. Intended Use / Indications for Use

5.4. Technological Characteristics

The images are displayed on a computer monitor. The images can be reviewed individually or as a self-playing sequence. The software can adjust the speed of the playback. In addition, the device software allows the user to save the screenshots as DIOM-compatible files and generate electronic reports.

BR-FHUS Viewer 1.0 requires the following:

◆ Off-the-Shelf PC Computer to run BR-FHUS Viewer 1.0, which meets the following requirements
- Minimum 500 GB Hard Drive
- A Minimum Intel Core i5 6400 processor
- Operating System: Windows A
- Minimum 8GB RAM
◆ Computer User Interface
- Keyboard
- A Mouse
- Display A
  - Minimum display size 17"

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Minimum display resolution 1920*1080

5.5. Comparison with Predicate Devices

BR-FHUS Viewer 1.0 is substantially equivalent to Tractus TissueMapper Reviewer Application (K123901) with a general intended use for reviewing ultrasound images with probe's position. 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-FHUS Viewer 1.0, k TBD	Tractus TissueMapperReviewer Application,K123901
Manufacturer	TaiHao Medical Inc.	Tractus Corporation
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
Intended Use / Indications forUse	BR-FHUS Viewer 1.0 isintended as a standalonesoftware device installed on astandalone windows-basedcomputer to assist physicianswith manipulation andanalysis tools in reviewingbreast ultrasound images.Images and data are previouslyrecorded from various imagingsystems and other sourcessuch as calibrated spatialpositioning devices. BR-FHUS Viewer 1.0 provides thecapability to visualize two-	The Tractus TissueMapperReviewer Applicationprovides two and threedimensional image review,manipulation, and analysistools to assist users inscreening, diagnosis, planningand performing image-guidedinterventional procedures.The supported imagingmodality is Ultrasound (US).Images and data are receivedfrom various imaging systemsand other sources such ascalibrated spatial positioning
	dimensional ultrasound imagesalong with the scanning pathsand position information ofprobe that stored in theDICOM file in advance.	devices. This device providesthe capability to overlayannotations on 2D or 3Dmedical image displays.These annotations mayrepresent the position ofinstruments including but notlimited to imaging probes orother tracked devices. Thisdevice is intended to assistskilled medical professionalsin clinical screening andinterventions, for anatomicalstructures where imaging iscurrently used for visualizingsuch structures, includinghead and neck, breast,thoracic, and abdominalapplications.
User Population	Skilled medical professionals	Skilled medical professionals
Primary Components	Software: BR-FHUS Viewer1.0	Software: TissueMapperReviewer Application
Accessories	Computer (PC) and storagemedia (USB)	Computer (PC) and storagemedia (USB)
Primary Application	Breast	Head and neck, breast,thoracic, and abdominal
Software	Yes	Yes
3-D Rendering	No	Yes
Reporting	Yes	Yes
Supported Imaging Modalities	Ultrasound	Ultrasound

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Software Level of Concern	Moderate level of concern	Moderate level of concern
Annotate position ofinstruments	Yes	Yes
Performance Testing	Results from softwareverification and validationtesting performed per internalprocedures.	From the 510(k) Summarythat is available on the FDAdatabase, it appears that nodata from performance testingwas submitted.

5.6. Performance Data

Performance, Verification and Validation testing for BR-FHUS Viewer 1.0 was performed per internal procedures to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated workenvironment using breast phantom to obtain the functional and accuracy test results.

The result of these tests demonstrate that BR-FHUS Viewer 1.0 validation is with in specification. As such. BR-FHUS Viewer 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today.

BR-FHUS Viewer 1.0 indications for use are drawn from the indications for use of a legally marketed predicate device: Tractus TissueMapper Image Reviewer Application. BR-FHUS Viewer 1.0 draws from features of this predicate device. As such, the features provided by BR-FHUS Viewer 1.0 do not in themselves raise new concerns of safety or effectiveness.

In all instances, BR-FHUS Viewer 1.0 functioned as intended and the operation observed was as expected.

5.7. Substantial Equivalence

The intended use, technological characteristics, and major functionality of BR-FHUS Viewer 1.0. are similar to the predicate device. Neither new safety nor new effectiveness issues are introduced during or after using this device. The performance data generated, as described, demonstrates that our device is as safe and effective, as compared to the predicate device. Therefore, we believe BR-FHUS 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).