AmCAD-UT® Detection 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 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® Detection 2.2 is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images of user selected regions of interest (ROI).

After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT Detection to analyze thyroid images for further interpretation. The physician selects an ROI to define the initial boundary of the ROI. 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 Detection. 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 the AmCAD-UT® Detection 2.2 device and its performance study to support its substantial equivalence to a predicate device. Here's a breakdown of the requested information:

Device Acceptance Criteria and Performance

The document doesn't explicitly lay out a table of "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it describes "performance data" that "demonstrates that the proposed device performs as safely and effectively as the predicate devices." The core acceptance is based on demonstrating substantial equivalence to the predicate device (AmCAD-UT® Detection, Version 2.0) through standalone and clinical performance testing.

However, the "Functional Capability of Image Processing" for the device (AmCAD-UT® Detection 2.2) provides implicit performance goals related to the detection and quantification of certain sonographic characteristics.

Here’s a table presenting the device's functional performance capabilities as described, rather than explicit acceptance criteria with numerical targets:

Acceptance Criteria (Implicit from Functional Capabilities)	Reported Device Performance (Summary from study conclusions)
Qualitative/Functional: Ability to assist medical professionals in analyzing thyroid ultrasound images.	"The results of the MRMC study demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.2 can enhance their ability in analyzing the sonographic characteristics and has led to a significant increase in effectiveness of making clinical judgment."
Qualitative/Functional: Ability to provide detailed information with quantification and visualization of sonographic characteristics of thyroid nodules.	"The standalone studies evaluated the performance of the quantified sonographic characteristics (hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) on images acquired from ultrasound systems of different brands and showed that the device is effective in detecting the sonographic characteristics of thyroid nodules acquired from various ultrasound systems." "two quantified and visualized sonographic characteristics, i.e. margin distinctness and tumor orientation, are added." "gauge meters expressing the quantified values of sonographic characteristics are also added for convenience of the medical professionals' reading."
Generalizability: Effectiveness on images acquired from various FDA-cleared ultrasound systems.	"The standalone studies evaluated the performance of the quantified sonographic characteristics... on images acquired from ultrasound systems of different brands and showed that the device is effective in detecting the sonographic characteristics of thyroid nodules acquired from various ultrasound systems."
Safety and Effectiveness: Performance as safely and effectively as the predicate device (AmCAD-UT® Detection 2.0).	"The performance data demonstrates that the proposed device performs as safely and effectively as the predicate devices. Therefore, AmCAD-UT® Detection 2.2 is substantially equivalent to the predicate devices..."

Study Details

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated. The document refers to "the test set" for ground truth establishment but does not provide a specific number of cases or images used for the performance studies.
- Data Provenance:
  - Country of origin: Not explicitly stated in the provided text. The manufacturer is AmCad BioMed Corporation, located in Taipei, Taiwan, R.O.C., suggesting the data could be from Taiwan, but this is not confirmed.
  - Retrospective or Prospective: Not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated. The document mentions "clinical reader performance studies" and "ground truth to be established... include the ROI, the presence of each sonographic characteristic, and the surgical pathology examination result." It does not specify how many experts were involved in establishing the ground truth from the images themselves.
- Qualifications of experts: Not explicitly stated beyond "medical professionals" or "physicians."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated. The document mentions "ground truth to be established" but does not detail the adjudication process (e.g., consensus, majority vote with tie-breaker).
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: Yes, a "clinical Multiple-Reader-Multiple-Case (MRMC) study" was done for the AmCAD-UT® Detection 2.2.
- Effect size: The document states: "The results of the MRMC study demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.2 can enhance their ability in analyzing the sonographic characteristics and has led to a significant increase in effectiveness of making clinical judgment." However, it does not provide a specific numerical effect size (e.g., AUC increase, sensitivity/specificity improvement). It only states that the improvement was "significant."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, "standalone performance testing" was conducted. It evaluated the device's effectiveness in detecting and quantifying sonographic characteristics on images from various ultrasound systems.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for performance studies included:
  - Region of Interest (ROI)
  - Presence of each sonographic characteristic
  - Surgical pathology examination result (This is a strong objective ground truth for malignancy status where available).
The sample size for the training set:
- The document does not provide the sample size used for the training set.
How the ground truth for the training set was established:
- The document does not describe how the ground truth for the training set was established. It only mentions "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." This statement appears in the context of "Ground Truth Establishment" for the device itself and its performance evaluation, not specifically for a separate training set if machine learning was involved. Given it's a CADe device, it likely involved training, but the details are not provided.

Summary

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AmCAD BioMed Corporation % Chiu S. Lin President Lin & Associates, LLC 5614 Johnson Avenure BETHESDA MD 20817

August 31st, 2018

Re: K180006

Trade/Device Name: AmCAD-UT Detection 2.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 1, 2018 Received: August 3, 2018

Dear Chiu 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Balygo

for Robert A. 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) K180006

Device Name AmCAD-UT® Detection 2.2

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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Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized "A" with a "C" 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.

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:	Jack Yang
Title:	Vice President
Phone:	886-2-2713-6227 ext.358
Fax:	886-2-2514-0245
Email:	jack.yang@amcad.com.tw
Manufacturer:	AmCad BioMed Corporation
US Agent and Contact:	Chiu S. Lin, Ph.D.Lin & Associates, LLC
Address:	5614 Johnson AvenueBethesda, MD 20817
Phone:	(O) 301-591-3895

Date prepared: December 27, 2017

5.2 Identification of Product

E-mail:

Device Trade Name:	AmCAD-UT® Detection 2.2
Common and Usual Name:	Computer-Assisted Detection (CADe) Device
Device Classification Name:	Picture Archiving and Communications System
Regulation Number:	21 CFR 892.2050
Classification Product Code:	LLZ
Classification Panel:	Radiology

cslin@lin-associates.com

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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 stylized blue "A" with a "C" 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.

Classification: Manufacturer:

Class II AmCad BioMed Corporation

5.3 Predicate Device

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

Model:	AmCAD-UT® Detection, Version 2.0
Manufacturer:	AmCad BioMed Corporation
510(k) Number:	K122536

5.4 Device Description

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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 image of a building with a "C" inside a circle on top. 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.

5.5 Indications for Use

AmCAD-UT® Detection 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.

5.6 Comparison with Predicate Devices

AmCAD-UT® Detection 2.2 is a computer-assisted detection (CADe) device which provides viewing and post-acquisition image processing and analysis of thyroid ultrasound images with user-selected 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 2.0
Manufacturer:	AmCad BioMed Corporation
510(k) Number:	K122536

The comparison as described in the following table:

	AmCAD-UT® Detection 2.2	AmCAD-UT® Detection 2.0
Manufacturer	AmCad BioMed Corp.	AmCad BioMed Corp.
510(k) Number	K180006	K122536
DeviceCommon Name	Computer-Assisted Detection(CADe)	Computer-Assisted Detection(CADe)
RegulationNumber	21 CFR 892.2050 - Class II	21 CFR 892.2050 - Class II
	AmCAD-UT® Detection 2.2	AmCAD-UT® Detection 2.0
Regulation Name	Picture archiving and communications system	Picture archiving and communications system
Product Code	LLZ	LLZ
Intended Use	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 quantification and visualization of sonographic characteristics of thyroid nodules.	AmCAD-UT® Detection 2.0 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 quantification and visualization of sonographic characteristics of thyroid nodules.
Indications for Use	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	AmCAD-UT® Detection 2.0 is a Windows-based computer-aided detection (CADe) device 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 quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has
	AmCAD-UT® Detection 2.2	AmCAD-UT® Detection 2.0
	images of discrete thyroidnodules larger than 1cm, forwhich a biopsyrecommendation is required.	been recommended. Thedevice performance has beenvalidated on images collectedfrom Philips HDI5000 with a5-12MHz multi-frequencyprobe.
FunctionalCapability ofImageProcessing	AmCAD-UT® Detection 2.2analyzes the user-selectedregions of interest (ROI) ofthyroid ultrasound image forthe detection andquantification of sonographiccharacteristics (hyperechoicfoci, echogenicity, texture,margin, orientation andanechoic areas). The devicefurther provides detailedinformation with visualizationof sonographic characteristicsof thyroid nodules.	AmCAD-UT® Detection 2.0analyzes the user-selectedregions of interest (ROI) ofthyroid ultrasound image forthe detection andquantification of sonographiccharacteristics (hyperechoicfoci, echo-pattern,echo-texture and anechoicareas). The device furtherprovides detailed informationwith visualization ofsonographic characteristics ofthyroid nodules.
ReadingParadigm	AmCAD-UT® Detection 2.2 isto provide quantification andvisualization of sonographiccharacteristics afterphysicians' initial review of theimages.	For use as "second reader"meaning that the function ofAmCAD-UT® Detection 2.0 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
	AmCAD-UT® Detection 2.2	AmCAD-UT® Detection 2.0
Software Design	Based on Statistical PatternRecognition and Quantificationmethod	Based on Statistical PatternRecognition and Quantificationmethod
Ground TruthEstablishment	The ground truth to beestablished for performancestudies of the device includesthe ROI, the presence of eachsonographic characteristic,and the surgical pathologyexamination result.	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
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 andclinical performance testing(MBMC study)	Standalone performanceassessment and clinical MRMCstudy.

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Image /page/6/Picture/0 description: The image contains the logo for AmCad BioMed Corporation. The logo consists of a blue letter 'A' with a circle in the upper right corner, followed by the company name in both Chinese and English. The Chinese characters are "安克生醫股份有限公司", and the English name is "AmCad BioMed Corporation".

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Image /page/7/Picture/0 description: The image shows the logo for AmCad BioMed Corporation. The logo consists of a blue stylized letter "A" with a circle inside, followed by the company name in both Chinese and English. The Chinese characters are placed above the English text, which reads "AmCad BioMed Corporation."

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Image /page/8/Picture/0 description: The image shows the logo for AmCad BioMed Corporation. The logo consists of a blue letter "A" with a circle in the upper right corner, followed by the company name in both Chinese and English. The Chinese characters are above the English text, and both are in black font. The logo appears to be for a biomedical company.

NO.167. Fu Hsing N. RD. Tel: +886-2-27136227

AmCAD-UT® Detection 2.2 is substantially equivalent to AmCAD-UT® Detection 2.0 that provides display and post-acquisition image analysis of ultrasound images assisting the physician in analyzing the ultrasound images of thyroid nodules. The standalone and clinical reader performance assessment results of AmCAD-UT® Detection 2.2 are substantially equivalent to the standalone performance assessment and clinical MRMC reader study of AmCAD-UT® Detection 2.0. Minor technological characteristics differences do not raise any new questions of safety and effectiveness.

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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 "A" with a "C" inside. Below 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.

Thus, AmCAD-UT® Detection 2.2 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® Detection 2.2 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 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 and clinical reader performance studies to validate and assess the performance of the AmCAD-UT® Detection 2.2 for its intended use. The standalone studies evaluated the performance of the quantified sonographic characteristics (hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) on images acquired from ultrasound systems of different brands and showed that the device is effective in detecting the sonographic characteristics of thyroid nodules acquired from various ultrasound systems.

The intended use of the AmCAD-UT® Detection 2.2 was validated in a clinical Multiple-Reader-Multiple-Case (MRMC) study. The results of the MRMC study demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.2 can enhance their ability in analyzing the sonographic characteristics and has led to a significant increase in effectiveness of making clinical judgment.

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Image /page/10/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" inside a square. Below the logo is the company name in both Chinese and English. The contact information includes the address: FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, as well as the telephone number: +886-2-27136227 and fax number: +886-2-25140245.

5.10 Conclusions

AmCAD-UT® Detection 2.2, being a computer assisted detection (CADe) software device, has the same intended use as the predicate device. In addition to generalizing the use of the device for ultrasound images acquired from various FDA-cleared ultrasound systems, two quantified and visualized sonographic characteristics, i.e. margin distinctness and tumor orientation, are added. On the user interface of the proposed device, gauge meters expressing the quantified values of sonographic characteristics are also added for convenience of the medical professionals' reading. The performance data demonstrates that the proposed device performs as safely and effectively as the predicate devices. Therefore, AmCAD-UT® Detection 2.2 is substantially equivalent to the predicate devices as the CADe device intended to assist the medical professionals in analyzing ultrasound images of thyroid nodules in clinical practice.

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).