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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for AmCAD-UT, a computer-aided detection (CADe) device for analyzing thyroid ultrasound images.

Here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity/specificity thresholds). Instead, it states that "the performance data demonstrates that it performs effectively and the device is as safe and effective as the predicate device."

However, it does mention that "the device was effective in determining the contour of thyroid nodules." This refers to the performance of the AI-suggested ROI contouring, which is a new feature compared to the predicate.

Given the information, a table would look something like this, acknowledging the lack of specific quantitative acceptance criteria:

Acceptance Criteria	Reported Device Performance
Demonstrates effective performance in AI-suggested ROI contouring of thyroid nodules.	The device was effective in determining the contour of thyroid nodules. Performance data demonstrates it performs effectively and is as safe and effective as the predicate device.

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

The document does not specify the exact sample size (number of images or nodules) used for the test set in the standalone performance studies.

Regarding data provenance: While not explicitly stated, it's mentioned that the images are "acquired from FDA-cleared ultrasound systems." The manufacturer is AmCad BioMed Corporation, located in Taiwan, R.O.C. It is likely the data originated from (or was collected by) clinical sites associated with the manufacturer or collaborating institutions, possibly in Taiwan or internationally, but this is not explicitly stated. The study type is referred to as "standalone performance studies."

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

The document states: "The ground truth to be established for performance studies of the device is the ROI labeled by a panel of specialists."

Number of experts: "a panel of specialists" (the exact number is not specified).
Qualifications of experts: "specialists" (specific qualifications, e.g., "radiologist with 10 years of experience", are not provided).

4. Adjudication method for the test set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for the ground truth establishment by the "panel of specialists." It simply says the ground truth is the "ROI labeled by a panel of specialists," implying consensus or a collective determination, but without detailing the process.

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

Was an MRMC study done? No, an MRMC comparative effectiveness study was not done for this particular submission. The "Performance Testing Data to Support SE Determination" table explicitly contrasts the current device's data ("Results from standalone performance testing of the AI suggested ROI's of user-selected nodules") with the predicate device's data, which included "Results from standalone performance testing and clinical performance testing (MRMC study)." This indicates that the MRMC study was performed for the predicate device (K180006), not for the new K203555 submission.
Effect size of human reader improvement: Since an MRMC study was not performed for this device, no effect size of human readers improving with AI vs. without AI assistance is reported for K203555.

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

Yes, a standalone performance study was done. The document states:

"AmCad BioMed Corporation has conducted standalone performance studies to validate and assess the performance of the AmCAD-UT for its added function of AI-suggested ROI contouring."
"The standalone studies evaluated the performance of the contours suggested by the AI algorithm of user-selected nodules..."

7. The type of ground truth used

The document states:

"The ground truth to be established for performance studies of the device is the ROI labeled by a panel of specialists."
This indicates the ground truth for the ROI contouring was established by expert consensus/labeling.

It's worth noting that the ground truth for the predicate device (AmCAD-UT® Detection 2.2) included "the ROI, the presence of each sonographic characteristic, and the surgical pathology examination result," suggesting a more comprehensive ground truth for the predicate, potentially including pathology as a definitive outcome. However, for the current device's specific new function (AI-suggested ROI), the ground truth focus is on expert-labeled ROI.

8. The sample size for the training set

The document does not specify the sample size used for the training set.

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

The document does not explicitly state how the ground truth for the training set was established. It only discusses the ground truth for "performance studies," which typically refers to test/validation sets. However, it's reasonable to infer that the training data would be labeled by similar expert methods, but this is not confirmed in the provided text.

Summary

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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

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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 (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

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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:

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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

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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
RegulationNumber	21 CFR 892.2050 - Class II	21 CFR 892.2050 - Class II
RegulationName	Medical Image Managementand Processing System	Medical Image Managementand Processing System
Product Code	QIH	LLZ
Intended Use	AmCAD-UT is intended toassist the medicalprofessionals in analyzingthyroid ultrasound images byquantification and visualizationof sonographic characteristicsof thyroid nodules.	AmCAD-UT® Detection 2.2 isintended to assist the medicalprofessionals in analyzingthyroid ultrasound images ofuser-selected regions ofinterest (ROI). After the initialreview of the ultrasoundimages by the physicians, thedevice further providesdetailed information with
	AmCAD-UT	AmCAD-UT® Detection 2.2
Indications forUse	AmCAD-UT is aWindows-basedcomputer-aided detection(CADe) device intended toassist the medicalprofessionals in analyzingthyroid ultrasound images,acquired from FDA-clearedultrasound systems. Theregion of interest (ROI) of auser-selected thyroid nodule isdefined by users or suggestedby an Al contouring algorithm.After the initial review of theultrasound images by thephysicians, the device furtherprovides detailed informationwith quantification andvisualization of sonographiccharacteristics of thyroidnodules. The device isintended for use on ultrasoundimages of discrete thyroidnodules larger than 1cm, forwhich a biopsyrecommendation is required.	AmCAD-UT® Detection 2.2 is aWindows-basedcomputer-aided detection(CADe) device intended toassist the medicalprofessionals in analyzingthyroid ultrasound images,acquired from FDA-clearedultrasound systems, withuser-selected regions ofinterest (ROI). After the initialreview of the ultrasoundimages by the physicians, thedevice further providesdetailed information withquantification and visualizationof sonographic characteristicsof thyroid nodules. The deviceis intended for use onultrasound images of discretethyroid nodules larger than1cm, for which a biopsyrecommendation is required.
FunctionalCapability ofImageProcessing	AmCAD-UT analyzes theuser-defined or Al-suggestedregions of interest (ROI) of auser-selected thyroid nodulefor detection andquantification of sonographiccharacteristics (hyperechoic	AmCAD-UT® Detection 2.2analyzes the user-selectedregions of interest (ROI) ofthyroid ultrasound image forthe detection andquantification of sonographiccharacteristics (hyperechoic
	AmCAD-UT	AmCAD-UT® Detection 2.2
	foci, echogenicity, texture,margin, orientation andanechoic areas). The devicefurther provides detailedinformation with visualizationof sonographic characteristicsof thyroid nodules.	foci, echogenicity, texture,margin, orientation andanechoic areas). The devicefurther provides detailedinformation with visualizationof sonographic characteristicsof thyroid nodules.
ReadingParadigm	AmCAD-UT is to providequantification andvisualization of sonographiccharacteristics afterphysicians' initial review of theimages.	AmCAD-UT® Detection 2.2 isto provide quantification andvisualization of sonographiccharacteristics afterphysicians' initial review of theimages.
OutputGenerated bythe CAD Device	The image can be annotatedwith the detected sonographiccharacteristics and berecorded by the device. Thesoftware also automaticallygenerates reports given theuser preference inputs in theanalysis process.	The image can be annotatedwith the detected sonographiccharacteristics and berecorded by the device. Thesoftware also automaticallygenerates reports given theuser preference inputs in theanalysis process.
Type of Film tobe Processedby the CADDevice	Digital ultrasound image	Digital ultrasound image
SoftwareDesign	Based on Al, Statistical PatternRecognition and Quantificationmethod	Based on Statistical PatternRecognition and Quantificationmethod
Ground TruthEstablishment	The ground truth to beestablished for performancestudies of the device is the ROIlabeled by a panel ofspecialists.	The ground truth to beestablished for performancestudies of the device includesthe ROI, the presence of eachsonographic characteristic, andthe surgical pathologyexamination result.
Platform	Window-based	Window-based
OperatingSystem	Standard PC or review station	Standard PC or review station
ClinicalApplication	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
ROIQuantification	Yes	Yes
AutomaticallyGeneratingReport	Yes	Yes
Report Storage	Paper printers, Local disk	Paper printers, Local disk
PerformanceTesting Data toSupport SEDetermination	Results from standaloneperformance testing of the AIsuggested ROI's ofuser-selected nodules	Results from standaloneperformance testing andclinical performance testing(MRMC study)

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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

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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

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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

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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

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.

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.

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).