K Number

Device Name

AmCAD-UT

Manufacturer

AmCad BioMed Corporation

Date Cleared

2021-09-08

(275 days)

Product Code

QIH

Regulation Number

892.2050

Intended Use

AmCAD-UT is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Description

AmCAD-UT is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images with the region of interest (ROI) of a selected nodule defined by users or suggested by an Al algorithm after the user specifies the location of the nodule. After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT to analyze thyroid images for further interpretation. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) by AmCAD-UT. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation. The software application automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180006

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The document explicitly mentions an "AI contouring algorithm" and "Al-suggested ROI contouring" as a function of the device.

Therapeutic

No.
The device assists medical professionals in analyzing thyroid ultrasound images for diagnosis and prognosis, but it does not directly treat or prevent a disease or condition.

Diagnostic

Yes
Explanation: The device is described as a "computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images" and provides "detailed information with quantification and visualization of sonographic characteristics of thyroid nodules" to assist in "complete interpretation," which are all characteristic functions of a diagnostic device.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "Windows-based computer-assisted detection (CADe) software application device" and its function is solely based on processing and analyzing ultrasound images. There is no mention of accompanying hardware components or hardware-specific validation.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
AmCAD-UT's Function: AmCAD-UT analyzes ultrasound images of the thyroid. It processes and quantifies characteristics within these images to assist medical professionals in interpreting the images and making decisions about thyroid nodules. It does not analyze biological samples from the patient.

Therefore, AmCAD-UT falls under the category of a medical image analysis software or computer-aided detection (CADe) device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The relevant text explicitly states "Not Found" for "Control Plan Authorized (PCCP) and relevant text."

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

QIH

Device Description

After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT to analyze thyroid images for further interpretation. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) by AmCAD-UT. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation.

The software application automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

Ultrasound Image

Anatomical Site

thyroid nodules

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

AmCad BioMed Corporation has conducted standalone performance studies to validate and assess the performance of the AmCAD-UT for its added function of Al-suggested ROI contouring. The standalone studies evaluated the performance of the contours suggested by the AI algorithm of user-selected nodules on images acquired from FDA-cleared ultrasound systems and showed that the device was effective in determining the contour of thyroid nodules.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180006

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

AmCad BioMed Corporation % Nathan Liu Product Specialist FL.5-2, NO.167, Fu Hsing N. RD. Taipei 105 TAIWAN

September 8, 2021

Re: K203555

Trade/Device Name: AmCAD-UT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: July 30, 2021 Received: August 2, 2021

Dear Nathan Liu:

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

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 (QS) 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 mediation-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

Indications for Use

510(k) Number (if known) K203555

Device Name AmCAD-UT

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside. Next to the logo is the company name in both Chinese and English. The address is listed as FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-25140245.

K203555 510(k) Summary of Safety and Effectiveness

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:	AmCad BioMed Corporation
Address:	FL.5-2, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, R.O.C.
Phone:	886-2-2713-6227
Fax:	886-2-2514-0245
Contact:	Nathan Liu
Title:	Product Specialist
Phone:	886-2-2713-6227 ext.2337
Fax:	886-2-2514-0245
Email:	Nathan.liu@amcad.com.tw
Manufacturer:	AmCad BioMed Corporation

Date prepared:	November 27, 2020
Date revised:	September 02, 2021

5.2 Identification of Product

Submission Number:	K203555
Device Trade Name:	AmCAD-UT
Device Classification Name:	Medical Image Management and Processing System
Regulation Number:	21 CFR 892.2050
Classification Product Code:	QIH
Classification Panel:	Radiology
Classification:	Class II
Manufacturer:	AmCad BioMed Corporation

5.3 Predicate Device

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

Image /page/4/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "A" with a white circle inside. The text includes the company name in both Chinese and English, followed by the address: FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-25140245.

Model: AmCAD-UT Detection 2.2 Manufacturer: AmCad BioMed Corporation 510(k) Number: K180006

5.4 Device Description

5.5 Indications for Use

Image /page/5/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" next to the company's name in both Chinese and English. Below the name is the company's address: FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-25140245.

provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

5.6 Comparison with Predicate Devices

AmCAD-UT is a computer-assisted detection (CADe) device which provides viewing and post-acquisition image processing and analysis of thyroid ultrasound images with regions of interest (ROI) and automatically generates reports from user inputs annotated during the image analysis process. This software medical device is substantially equivalent to the predicate device listed below:

Model:	AmCAD-UT® Detection, Version 2.2
Manufacturer:	AmCad BioMed Corporation
510(k) Number:	K180006

The comparison as described in the following table:

	AmCAD-UT	AmCAD-UT® Detection 2.2
Manufacturer	AmCad BioMed Corp.	AmCad BioMed Corp.
510(k) Number	K203555	K180006
Regulation
Number	21 CFR 892.2050 - Class II	21 CFR 892.2050 - Class II
Regulation
Name	Medical Image Management
and Processing System	Medical Image Management
and Processing System
Product Code	QIH	LLZ
Intended Use	AmCAD-UT is intended to
assist the medical
professionals in analyzing
thyroid ultrasound images by
quantification and visualization
of sonographic characteristics
of thyroid nodules.	AmCAD-UT® Detection 2.2 is
intended to assist the medical
professionals in analyzing
thyroid ultrasound images of
user-selected regions of
interest (ROI). After the initial
review of the ultrasound
images by the physicians, the
device further provides
detailed information with
	AmCAD-UT	AmCAD-UT® Detection 2.2
Indications for
Use	AmCAD-UT is a
Windows-based
computer-aided detection
(CADe) device intended to
assist the medical
professionals in analyzing
thyroid ultrasound images,
acquired from FDA-cleared
ultrasound systems. The
region of interest (ROI) of a
user-selected thyroid nodule is
defined by users or suggested
by an Al contouring algorithm.
After the initial review of the
ultrasound images by the
physicians, the device further
provides detailed information
with quantification and
visualization of sonographic
characteristics of thyroid
nodules. The device is
intended for use on ultrasound
images of discrete thyroid
nodules larger than 1cm, for
which a biopsy
recommendation is required.	AmCAD-UT® Detection 2.2 is a
Windows-based
computer-aided detection
(CADe) device intended to
assist the medical
professionals in analyzing
thyroid ultrasound images,
acquired from FDA-cleared
ultrasound systems, with
user-selected regions of
interest (ROI). After the initial
review of the ultrasound
images by the physicians, the
device further provides
detailed information with
quantification and visualization
of sonographic characteristics
of thyroid nodules. The device
is intended for use on
ultrasound images of discrete
thyroid nodules larger than
1cm, for which a biopsy
recommendation is required.
Functional
Capability of
Image
Processing	AmCAD-UT analyzes the
user-defined or Al-suggested
regions of interest (ROI) of a
user-selected thyroid nodule
for detection and
quantification of sonographic
characteristics (hyperechoic	AmCAD-UT® Detection 2.2
analyzes the user-selected
regions of interest (ROI) of
thyroid ultrasound image for
the detection and
quantification of sonographic
characteristics (hyperechoic
	AmCAD-UT	AmCAD-UT® Detection 2.2
	foci, echogenicity, texture,
margin, orientation and
anechoic areas). The device
further provides detailed
information with visualization
of sonographic characteristics
of thyroid nodules.	foci, echogenicity, texture,
margin, orientation and
anechoic areas). The device
further provides detailed
information with visualization
of sonographic characteristics
of thyroid nodules.
Reading
Paradigm	AmCAD-UT is to provide
quantification and
visualization of sonographic
characteristics after
physicians' initial review of the
images.	AmCAD-UT® Detection 2.2 is
to provide quantification and
visualization of sonographic
characteristics after
physicians' initial review of the
images.
Output
Generated by
the CAD Device	The image can be annotated
with the detected sonographic
characteristics and be
recorded by the device. The
software also automatically
generates reports given the
user preference inputs in the
analysis process.	The image can be annotated
with the detected sonographic
characteristics and be
recorded by the device. The
software also automatically
generates reports given the
user preference inputs in the
analysis process.
Type of Film to
be Processed
by the CAD
Device	Digital ultrasound image	Digital ultrasound image
Software
Design	Based on Al, Statistical Pattern
Recognition and Quantification
method	Based on Statistical Pattern
Recognition and Quantification
method
Ground Truth
Establishment	The ground truth to be
established for performance
studies of the device is the ROI
labeled by a panel of
specialists.	The ground truth to be
established for performance
studies of the device includes
the ROI, the presence of each
sonographic characteristic, and
the surgical pathology
examination result.
Platform	Window-based	Window-based
Operating
System	Standard PC or review station	Standard PC or review station
Clinical
Application	Thyroid cancers	Thyroid cancers
	AmCAD-UT	AmCAD-UT® Detection 2.2
Image Type	Ultrasound Image	Ultrasound Image
Image Format	DICOM3.0, Bitmap, JPEG	DICOM3.0, Bitmap, JPEG
ROI
Quantification	Yes	Yes
Automatically
Generating
Report	Yes	Yes
Report Storage	Paper printers, Local disk	Paper printers, Local disk
Performance
Testing Data to
Support SE
Determination	Results from standalone
performance testing of the AI
suggested ROI's of
user-selected nodules	Results from standalone
performance testing and
clinical performance testing
(MRMC study)

Image /page/6/Picture/0 description: The image shows the logo of Anke Bio Co., Ltd. The logo consists of a blue circle with a white "C" inside, followed by the company name in traditional Chinese characters. The characters are arranged horizontally and are black in color. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other official documents.

TT - AmCad BioMed Corporation
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245

Image /page/7/Picture/0 description: The image contains the logo and name of Anke Biotechnology Co., Ltd. The logo is a blue rounded square with a white "C" inside. The text is in traditional Chinese characters and is arranged in two lines.

TT - AmCad BioMed Corporation
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245

FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245

Image /page/8/Picture/0 description: The image contains the logo and name of "Anke Sheng Medical Co., Ltd." The logo is a blue rounded shape with a white "C" inside. The name of the company is written in Chinese characters to the right of the logo. The text is black and in a simple font.

AmCad Blomed Corporation
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245

AmCAD-UT is substantially equivalent to AmCAD-UT® Detection 2.2 that provides display and post-acquisition image analysis of ultrasound images assisting the physician in analyzing the ultrasound images of thyroid nodules. The standalone performance assessment results of AmCAD-UT are shown substantially equivalent to AmCAD-UT® Detection 2.2. The minor technological difference, i.e., the addition of the Al-suggested ROI of a user-selected nodule, do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT is substantially equivalent to the predicate device as a Computer-Assisted Detection (CADe) device intended to assist the physicians in clinical practice.

5.7 Performance Standards

No applicable FDA performance standards have been issued under the authority of Section 514.

5.8 Software

Software development for the AmCAD-UT follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury

Image /page/9/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" next to the company's name in both Chinese and English. Below the name is the address: FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-25140245.

based on the use of the quantification results. 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

5.10 Conclusions

AmCAD-UT, being a computer assisted detection (CADe) software device, has the same intended use as the predicate device. The suggested ROI of a user-selected nodule is added in this proposed device and the performance data demonstrates that it performs effectively and the device is as safe and effective as the predicate device. AmCAD-UT is, therefore, substantially equivalent to the predicate devices as the new function of the device assists the medical professionals in identifying the contours of thyroid nodules without interfering with the analysis functions of the device.