(241 days)
Not Found
Unknown
The document describes "computer-assisted detection (CADe)" and "quantification of sonographic characteristics," which are common applications for AI/ML in medical imaging. However, it does not explicitly mention AI, ML, or deep learning, nor does it provide details about training or test sets, which are typical for AI/ML-based devices. The description of the processing steps (selecting ROI, processing for detection and quantification of characteristics) could potentially be implemented using traditional image processing techniques or AI/ML. Without explicit mention or further details, it's impossible to definitively confirm the presence of AI/ML.
No
The device aids in analysis and provides information for diagnosis, but it does not directly treat or prevent a disease or condition.
Yes
The device assists medical professionals in analyzing thyroid ultrasound images and provides detailed information with quantification of sonographic characteristics of thyroid nodules, assisting in diagnosis or a biopsy recommendation.
Yes
The device is described as a "Windows-based computer-assisted detection (CADe) software application device" and its function is to analyze images acquired from FDA-cleared ultrasound systems. It does not include or require any specific hardware beyond a standard computer and display for its operation.
Based on the provided information, 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 examine specimens outside of the body.
- Device Function: AmCAD-UT® Detection analyzes ultrasound images of the thyroid. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve the analysis of biological samples taken from the patient.
- Intended Use: The intended use is to assist medical professionals in analyzing ultrasound images and providing information about the sonographic characteristics of thyroid nodules. This is a form of medical imaging analysis, not in vitro testing.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound Image
Anatomical Site
Thyroid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals in clinical practice / Standard PC or review station
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 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.
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.
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
§ 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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
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
1
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)
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.
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 Avenue |
| Bethesda, 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 |
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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
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.
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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 |
| Device | ||
| Common Name | Computer-Assisted Detection | |
| (CADe) | Computer-Assisted Detection | |
| (CADe) | ||
| Regulation | ||
| Number | 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 thyroid | ||
| nodules larger than 1cm, for | ||
| which a biopsy | ||
| recommendation is required. | been recommended. The | |
| device performance has been | ||
| validated on images collected | ||
| from Philips HDI5000 with a | ||
| 5-12MHz multi-frequency | ||
| probe. | ||
| Functional | ||
| Capability of | ||
| Image | ||
| Processing | 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 | ||
| foci, echogenicity, texture, | ||
| margin, orientation and | ||
| anechoic areas). The device | ||
| further provides detailed | ||
| information with visualization | ||
| of sonographic characteristics | ||
| of thyroid nodules. | AmCAD-UT® Detection 2.0 | |
| analyzes the user-selected | ||
| regions of interest (ROI) of | ||
| thyroid ultrasound image for | ||
| the detection and | ||
| quantification of sonographic | ||
| characteristics (hyperechoic | ||
| foci, echo-pattern, | ||
| echo-texture and anechoic | ||
| areas). The device further | ||
| provides detailed information | ||
| with visualization of | ||
| sonographic characteristics of | ||
| thyroid nodules. | ||
| Reading | ||
| Paradigm | AmCAD-UT® Detection 2.2 is | |
| to provide quantification and | ||
| visualization of sonographic | ||
| characteristics after | ||
| physicians' initial review of the | ||
| images. | For use as "second reader" | |
| meaning that the function of | ||
| AmCAD-UT® Detection 2.0 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 |
| AmCAD-UT® Detection 2.2 | AmCAD-UT® Detection 2.0 | |
| Software Design | Based on 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 includes | ||
| the ROI, the presence of each | ||
| sonographic characteristic, | ||
| and the surgical pathology | ||
| examination result. | 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 |
| 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 and | ||
| clinical performance testing | ||
| (MBMC study) | Standalone performance | |
| assessment and clinical MRMC | ||
| study. |
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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.