AMCAD-UT DETECTION MODEL 2.0

• K Number: K122536
• Device Name: AMCAD-UT DETECTION MODEL 2.0
• Manufacturer: LIN & ASSOCIATES, LLC.
• Date Cleared: 2013-10-03 ( 409 days)
• Product Code: LLZ
• Regulation Number: 892.2050

Intended Use

AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted 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 been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.

Device Description

AmCAD-UT® Detection 2.0 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). The device uses statistical pattern recognition and quantification methods to perform analytical function of images. For thyroid ultrasound, these pattern recognition and quantification methods are used by a medical professional to analyze DICOM/JPEG/Bitmap compliant thyroid ultrasound images. The software application consists of proprietary software developed by AmCad BioMed Corporation. The software is a Windows-based that may be installed on a standalone PC or review station. AmCAD-UT® Detection 2.0 user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images. After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT® Detection 2.0 to analyze the thyroid images for further interpretation. The physician selects an ROI (Region of Interest) 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, echo-pattern, echo-texture, and anechoic areas) by AmCAD-UT® Detection 2.0. 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 also 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.

Predicate Devices

K021966, K050846, K083423

Reference Devices

K021966,K050846,K083423

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The description mentions "statistical pattern recognition and quantification methods" but does not explicitly state the use of AI or ML. Without further information or a more detailed description of the algorithms, it's not possible to definitively confirm or deny the presence of AI/ML.

Therapeutic

No
The device is a computer-assisted detection (CADe) device intended to assist medical professionals in analyzing thyroid ultrasound images. It provides detailed information, quantification, and visualization of sonographic characteristics of thyroid nodules to aid in interpretation, but it does not directly treat or diagnose.

Diagnostic

Yes

The device assists medical professionals in analyzing thyroid ultrasound images for diagnostic purposes by providing detailed quantification and visualization of sonographic characteristics of thyroid nodules, which enhances their ability to make clinical judgments.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "Windows-based computer-assisted detection (CADe) software application device" and states it "may be installed on a standalone PC or review station," indicating it is a software product that runs on general-purpose computing hardware, not a dedicated hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
• This device analyzes medical images: AmCAD-UT® Detection 2.0 analyzes ultrasound images of the thyroid. It processes and quantifies characteristics within these images.
• The intended use is image analysis: The intended use clearly states the device is "intended to assist the medical professionals in analyzing thyroid ultrasound images."

Therefore, while it's a medical device used in the diagnostic process, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted 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 been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.

Product codes

90 LLZ

Device Description

AmCAD-UT® Detection 2.0 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).

The device uses statistical pattern recognition and quantification methods to perform analytical function of images. For thyroid ultrasound, these pattern recognition and quantification methods are used by a medical professional to analyze DICOM/JPEG/Bitmap compliant thyroid ultrasound images.

The software application consists of proprietary software developed by AmCad BioMed Corporation. The software is a Windows-based that may be installed on a standalone PC or review station. AmCAD-UT® Detection 2.0 user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.

After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT® Detection 2.0 to analyze the thyroid images for further interpretation. The physician selects an ROI (Region of Interest) 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, echo-pattern, echo-texture, and anechoic areas) by AmCAD-UT® Detection 2.0. 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 also 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

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 2.0 for its intended use. The standalone studies include the detection accuracy testing, reproducibility testing, and algorithm stability testing.

The intended use of the AmCAD-UT® Detection 2.0 was validated in a clinical (MRMC) study. The results of the MRMC study demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.0 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)

K021966, K050846, K083423

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

K122536
Page 1 of 11

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:	[e-mail]
Manufacturer:	AmCad BioMed Corporation

| US Agent and Contact: | Chiu S. Lin, Ph.D.
Lin & Associates, LLC |
|-----------------------|-------------------------------------------------|
| Address: | 9223 Cambridge Manor Court
Potomac, MD 20854 |
| Phone: | (O) 301-591-3895 |
| E-mail: | [e-mail] |

Date prepared: August 17, 2012

5.2 Identification of Product

AmCAD-UT® Detection 2.0 Device Trade Name: Common and Usual Name: Computer-Assisted Detection (CAD) Device Device Classification Name: Picture Archiving and Communications System

1

Image /page/1/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. 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 [phone], while the fax number is [phone].

Regulation Number: 21 CFR 892.205 Classification Product Code: 90 LLZ Classification: Class II Classification Panel: Radiology Devices Manufacturer: AmCad BioMed Corporation

5.3 Predicate Device

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

Model:	Q LAB Software
Manufacturer:	Philips Medical System Company
510(k) Number:	K021966, cleared on July 2, 2002

Model: B-CAD System, Version 1.0 Manufacturer: Medipattem Corporation K050846, cleared on May 26, 2005 510(k) Number:

Model: ColonCAD API Manufacturer: Medicsight PLC 510(k) Number: K083423, cleared on May 17, 2011

5.4 Device Description

AmCAD-UT® Detection 2.0 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).

The device uses statistical pattern recognition and quantification methods to perform analytical function of images. For thyroid ultrasound, these pattern recognition and quantification methods are used by a medical professional to analyze DICOM/JPEG/Bitmap compliant thyroid ultrasound images.

2

Image /page/2/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. Below the logo is the company name in both Chinese and English. The address is listed as FL.S, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is [phone], while the fax number is [phone].

The software application consists of proprietary software developed by AmCad BioMed Corporation. The software is a Windows-based that may be installed on a standalone PC or review station. AmCAD-UT® Detection 2.0 user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.

After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT® Detection 2.0 to analyze the thyroid images for further interpretation. The physician selects an ROI (Region of Interest) 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, echo-pattern, echo-texture, and anechoic areas) by AmCAD-UT® Detection 2.0. 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 also 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.

5.5 Indications for Use

AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted 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 been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.

3

Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized elephant-like figure with the letters 'C' and 'A' incorporated into its design. Below the logo is 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 [phone] and the fax number is [phone].

5.6 Comparison with Predicate Devices

AmCAD-UT® Detection 2.0 is substantially equivalent to Q LAB Software with a general intended use for viewing and quantifying ultrasound image data. AmCAD-UT® Detection 2.0 is also substantially equivalent to B-CAD, version 1.0 and ColonCAD API as being Computer-Assisted Detection software device to assist the physicians in clinical practice. The standalone and clinical reader performance assessment of AmCAD-UT® Detection 2.0 are substantially equivalent to the standalone performance assessment and clinical MRMC reader study of ColonCAD API. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT® Detection 2.0 is substantially equivalent to the Q LAB Software generally intended for viewing and quantifying ultrasound image data and substantially equivalent to the B-CAD System and ColonCAD API as the Computer-Assisted Detection device intended to assist the physicians in clinical practice.

The comparison table between our device and the predicate devices is provided below:

| | AmCAD-UT®
Detection 2.0 | B-CAD System
Version 1.0 | ColonCAD API | Q LAB Software |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Manufacturer | AmCad BioMed
Corp. | Medipattem
Corp. | Medicsight PLC | Philips Medical
System Company |
| 510(k) Number | K122536 | K050846 | K083423 | K021966 |
| Device
Common Name | Computer-Assisted
Detection (CADe) | Same | Same | Picture Archiving
and
Communications
Systems
Workstation |
| Regulation
Number | 21 CFR 892.2050 -
Class II | Same | Same | Same |
| Regulation
Name | Picture archiving
and
communications
system | Same | Same | Same |
| Product Code | LLZ | LLZ | NWE | LLZ |
| | AmCAD-UT®
Detection 2.0 | B-CAD System
Version 1.0 | ColonCAD API | Q LAB Software |
| Intended Use | 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. | The B-CAD
System provides
viewing and
post-acquisition
image analysis of
user-selected
regions of interest
on breast
ultrasound
images. | The Medicsight
ColonCAD API is
intended to be
used on patients
referred for a CT
colonography
(CTC)
examination, as
an overlay tool to
prompt the
radiologist to
colonic findings
that have been
identified by the
device. The CAD
can assist
radiologists after
they have made
an initial review
of all the
colonography.
image data,
supporting their
evaluation
( | |
| AmCAD-UT® | B-CAD System | ColonCAD API | Q LAB Software | |
| Detection 2.0 | Version 1.0 | | | |
| The device is | software | | | |
| intended for use | automatically | | | |
| on Philips HDI5000 | generates reports | | | |
| images of discrete | from user inputs | | | |
| thyroid nodules | annotated during | | | |
| larger than 1cm, | the image | | | |
| for which a biopsy | analysis process. | | | |
| has been | An output may be | | | |
| recommended. | viewed and sent | | | |
| The device | to standard film | | | |
| performance has | or paper printers | | | |
| been validated on | or sent | | | |
| images collected | electronically to | | | |
| from Philips | an intranet web | | | |
| HD15000 with a | server or other | | | |
| 5-12MHz | DICOM device. | | | |
| multi-frequency | The software may | | | |
| probe. | retrieve archived | | | |
| | reports from a | | | |
| | web server or | | | |
| | other DICOM | | | |
| | device. | | | |
| | B-CAD includes | | | |
| | the option to add | | | |
| | annotations | | | |
| | based on the | | | |
| | ACR-BI-RADS® | | | |
| | Breast Imaging | | | |
| | Atlas. In addition, | | | |
| | the report form | | | |
| | has been | | | |
| | designed to | | | |
| | support | | | |
| | compliance with | | | |
| | the ACR-BI-RADS®
Ultrasound
Lexicon
Classification
Form. | | | |
| | When interpreted | | | |
| | by a skilled | | | |
| | physician, this | | | |
| | device provides | | | |
| | information that | | | |
| | may be useful in | | | |
| | screening and | | | |
| | diagnosis. Patient | | | |
| | management | | | |
| | decisions should | | | |
| | not be made | | | |
| | | | | |

4

Image /page/4/Picture/0 description: The image shows the logo of Anke BioMedical Co., Ltd. The logo consists of a circled "C" symbol followed by the company name in traditional Chinese characters. The characters are arranged horizontally, with "Anke" followed by "BioMedical" and then "Co., Ltd."

J AmCad BioMed Corporation

.

5

Image /page/5/Picture/0 description: The image contains the logo and name of a company. The logo is a stylized letter C. Next to the logo is the company name in Chinese characters, which translates to "Anke Sheng Medical Co., Ltd." Below the Chinese name is the company name in English, "AmCad BioMed Corporation."

FLS, NO.167, Fo Hsing N. RD., Taipei 105, Taiwan, ROC
FL.S, NO.167, Fo Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: [phone] Fax: [phone]

6

Image /page/6/Picture/0 description: The image shows the logo for Anke Bio Co., Ltd. The logo consists of a stylized letter "C" with a small circle inside, followed by the company name in traditional Chinese characters. The text reads "安克生醫股份有限公司", which translates to Anke Bio Co., Ltd.

FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: [phone] - Fax: [phone]

| | AmCAD-UT®
Detection 2.0 | B-CAD System
Version 1.0 | ColonCAD API | Q LAB Software |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional
Capability of
Image
Processing | 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. | B-CAD System
Version 1.0
solely on the
results of B-CAD
analysis. The
ultrasound
images displayed
on B-CAD must
not be used for
primary
diagnostic
interpretation.
B-CAD
automatically
segments and
classifies shape
and orientation
characteristics of
user-selected
regions of interest
(ROI) of breast
ultrasound
images. | The device
highlights the
potential polyps
(of the colon) in
2D and 3 D image
views. The results
are displayed in
the form of "CAD
marks" on or near
the potential
polyps | The Q LAB
software provides
a means of
opening and
displaying
(ultrasonic) image
files, creating AVI
and BMP files
from the image
data displayed by
the software,
quantifying the
image data using
a plugin module
designed to
operate with the
core engine of the
software,
performing an
automatic
distance
measurement of
the intima media
thickness of an
artery
represented in
the image file
data, creating
region of interest
figures overlaid
on the image data
displayed by the
software,
analyzing the
content of the
image data
contained within
the ROI figure,
presenting the
ROI data in an XY |
| | AmCAD-UT® | B-CAD System | ColonCAD API | Q LAB Software |
| | Detection 2.0 | Version 1.0 | | |
| | | | | graphic format,
performing a
curve fit
operation on a
data set
generated by the
ROI analysis
software, and
exporting the
data generated by
the plugin
modules in a form
accessible to the
end user. |
| Reading
Paradigm | For use as "second
detector" 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. | Same | Same | The device
provides the
functions of
viewing and
quantifying image
data as a
"Quantification
Software" to the
physician in
analyzing the
ultrasound image. |
| 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 user may
select any view
for further
analysis of
anatomy and
pathology. The
software allows
the user to
annotate, tag,
measure, and
automatically
record selected
view. Results of
the analysis are
displayed on the
monitor and may
be selected by the
user for
automated
reporting. | Not known | The software can
export the data
generated by the
plugin modules in
a form accessible
to the end user. |
| Type of Film to
be Processed
by the device | Digital ultrasound
image | Digital ultrasound
image | Digital CT
colonography | Digital ultrasound
Image |

:

7

Image /page/7/Picture/0 description: The image contains a logo with a circled "C" and the text "安克生醫股份有限公司". The text is in a traditional Chinese font and is arranged horizontally. The logo and text appear to be a company name or trademark.

L.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: [phone] Fax: [phone]

న-8

8

Image /page/8/Picture/0 description: The image contains the logo of Anke Bio Co., Ltd. The logo consists of a circular symbol on the left, followed by the company's name in traditional Chinese characters. The characters are arranged horizontally, with each character clearly visible.

TT AmCad BioMed Corporation
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: [phone] Fax: [phone]

Tel: [phone]/ Fax: [phone]

| | AmCAD-UT®
Detection 2.0 | B-CAD System
Version 1.0 | ColonCAD API | Q LAB Software |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Software
Design | Based on
Statistical Pattern
Recognition and
Quantification
method | Based on
Mutivariate
Pattern
Recognition
method | Based on
Mathematical
Image Processing
Techniques | Not known |
| 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. | Not known | Not known | Not known |
| Platform | Window-based | Window 2000/XP,
DICOM
compatible | Not known | Windows
2000/XP |
| Operating
System | Standard PC or
review station | Same | Not known | Same |
| Clinical
Application | Thyroid cancers | Breast cancers | Colon cancers | Not specified; for
general intended
use |
| Image Type | Ultrasound Image | Same | CT image | Ultrasound Image |
| Image Format | DICOM3.0,
Bitmap, JPEG | DICOM3.0 | DICOM 3.0 | Image data
acquired on
Philips Medical
Systems
ultrasound
products |
| ROI
Quantification | Yes | Yes | No | Yes |
| Automatically
Generating
Report | Yes | Yes | Not known | Not known |
| Report Storage | Paper printers,
Local disk | Standard film,
paper printers,
web server, other
DICOM device | Not known | Not known |
| Performance
Testing Data to
Support SE
Determination | Results from
standalone
performance
testing and clinical
performance
testing MRMC | From the 510(k)
Summary that is
available on the
FDA database, it
appears that no
data from | Standalone
performance
assessment, and
clinical MRMC
study | From the 510(k)
Summary that is
available on the
FDA database, it
appears that no
data from |

9

Image /page/9/Picture/0 description: The image shows a logo with Chinese and English text. The Chinese text reads "安克生醫股份有限公司", and the English text reads "AnCac BioMed Corp.". The logo also includes a stylized graphic to the left of the text.

FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: [phone] Fax: [phone]

| AmCAD-UT®
Detection 2.0 | B-CAD System
Version 1.0 | ColonCAD API | Q LAB Software |
|----------------------------|-----------------------------|--------------|----------------------------|
| study) | standalone | | standalone |
| | performance
testing and | | performance
testing and |
| | reader | | reader |
| | performance | | performance |
| | testing were | | testing were |
| | submitted. | | submitted. |

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 2.0 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 2.0 for its intended use. The standalone studies include the detection accuracy testing, reproducibility testing, and algorithm stability testing.

The intended use of the AmCAD-UT® Detection 2.0 was validated in a clinical (MRMC) study. The results of the MRMC study demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.0

10

Image /page/10/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. 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 [phone], while the fax number is [phone].

can enhance their ability in analyzing the sonographic characteristics and has led to a significant increase in effectiveness of making clinical judgment.

5.10 Conclusions

The intended use of AmCAD-UT® Detection 2.0 as a CAD device is equivalent to the predicate devices in that it views, analyzes, quantifies, and visualizes the user selected radiologic images that may reveal abnormalities during analysis of patient radiologic images by the intended user. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT® Detection 2.0 is substantially equivalent to the predicate devices as the Computer-Assisted Detection (CAD) device intended to provide viewing and post-acquisition analysis functions for assisting the physicians in clinical practice.

11

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3. 2013

AmCad BioMed Corporation % Chiu S. Lin, Ph.D. President Lin & Associates, LLC 9223 Cambridge Manor Court POTOMAC MD 20854

Re: K122536

Trade/Device Name: AmCAD-UT® Detection Model 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 15, 2013 Received: August 16, 2013

Dear Dr. Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 11 (Special Controls) or class 111 (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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris 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): K122536

AmCad-UT Detection 2.0 Device Name:

Indications for Use:

AmCAD - UT® Detection 2.0 is a Windows - based computer - assisted 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 Icm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5 - 12MHz multi - frequency probe.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$(m.7)$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K122536 510(k)

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