Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The summary mentions "automatic extraction" and "automatic detection" which could potentially utilize AI/ML, but it does not explicitly state the use of these technologies. The lack of mention of AI/ML in the "Mentions AI, DNN, or ML" section and the absence of details about training/test sets make it impossible to confirm.

Therapeutic

No.
The device description states it is "medical imaging software that is intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning." It is explicitly used for "qualitative and quantitative analysis" and "measurement," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

Explanation: The "Intended Use/Indications for Use" section states that AutoSeg-H is "intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning" and provides "specific analysis applications which provide custom UI, targeted measurements and reporting functions." These functions, such as "qualitative and quantitative analysis of coronary arteries" and "automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves," are diagnostic activities.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that AutoSeg-H is "software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning" and that it "runs on Windows standalone installed on a commercial general-purpose Windows-compatible computer." It processes DICOM images acquired from a CT, but the device itself is the software running on a general-purpose computer, not the CT scanner or any other dedicated hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: AutoSeg-H is medical imaging software that processes and analyzes medical images (CT scans) acquired from an imaging device. It provides tools for professionals to aid in reading, interpreting, reporting, and treatment planning based on these images.
Lack of Biological Sample Analysis: The device does not analyze biological samples from the patient. Its input is image data, not biological specimens.

Therefore, AutoSeg-H falls under the category of medical imaging software, which is distinct from in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AutoSeg-H is medical imaging software that is intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, and right ventricle from CT.

Product codes

LLZ

Device Description

AutoSeg-H(V1.0.0.01) is software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. AutoSeg-H(V1.0.0.01) runs on Windows standalone installed on a commercial general-purpose Windows-compatible computer and accepts DICOM compliant medical images acquired from a CT. The AutoSeg-H is not connected to a PACS system directly but retrieves saved image data from a computer. Image data obtained from the computer are used for display, image processing, analysis, etc. AutoSeg-H cannot be used to interpret Mammography images.

The main functions of AutoSeg-H are shown below.

Coronary Artery Analysis (CT)
Aortic Valve Analysis (CT)
4-Chamber Analysis (CT)

AutoSeg-H operates on a window.
AutoSeg-H reads the CT DICOM image from its own device and analyzes them. (Standalone configuration)

The software employs an advanced active contour algorithm with entropy regularization, to implement semantic segmentation of target organs. The execution of this method results in 3D reconstruction of target organs.

In the configurations shown in Block diagram(Fig) offers trained medical professionals the following applications to analyze the image data retrieved from Computed tomography.

General Applications
- 1. Menu
    In the Menu application, user can import DICOM, load previous work file, extract 3D model, and save work files.
- 1. 2D Viewer
    The 2D Viewer can show axial view, sagittal view, coronary artery, aorta, and 4-chamber.
- 1. 3D Viewer (3D reconstruction)
    The 3D Viewer can show 3D reconstructed coronary artery, aorta, and 4-chamber.
- 1. Measurement
    The Measurement application can show what the user measured like distance between two points, angle, area. and perimeter of 2D and 3D view etc.
- 1. Manual Image Modification (Editing)
    By the modification application, users can select, draw, modify, and label specific areas on 2D or 3D view etc. .
- 1. Sequential Display
    The Sequential Display, sequentially displays a cross section of specified area. (Angle, play range, speed, direction can be set)
- 1. Setting
    In the Setting application, users can set brightness, initialize histogram, sync images, set 3D reconstruction image as volume, solid mesh and wire frame view, turn on/off patient information, coordinate display, crosshair and 3D view.
Analysis Applications
- 1. Coronary Artery Analysis
    The Coronary Artery Analysis application can reconstruct 3D Coronary Artery, display Cross section view, analyze Stenosis ratio, initialize the layout and turn on/off the Coronary Artery, Coronary Inner line.
- 1. Aortic Valve Analysis
    The Aortic Valve Analysis application can reconstruct 3D Aorta, mark the centerline, measure long axis, short axis, area, perimeter, and rotate the 3D image. Also can switch to the default layout, manually select the measurement location, initialize/save/display the measurement result.
- 1. 4-Chamber Analysis
    The 4-Chamber Analysis application can reconstruct 3D left atrium, left ventricle, right atrium, and right ventricle.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found. The segmentation method is based on an "advanced active contour algorithm for pattern recognition".

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

Heart (Coronary Arteries, Aorta, Valves, Left Atrium, Left Ventricle, Right Atrium, Right Ventricle)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained medical professionals / Not Found

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)

Non-clinical performance testing was performed to confirm that AutoSeg-H meets all performance test criteria and all functions are operating without errors, meets test standards for estimation of quantitative measurement error, and meets test standards for estimation of segmentation algorithm error. Software testing and validation were done according to written test protocols. Test results reviewed by designated technical professionals showed that AutoSeg-H meets all performance test criteria and all functions work without errors, supporting the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device. No clinical studies were considered necessary and performed.

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

Not Found

Predicate Device(s)

K200973

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

AI Medic Inc. % Jeong Song COO 2F, 437, Bongeunsa-ro, Gangnam-gu Seoul, KS013/06097 REPUBLIC OF KOREA

Re: K220039

July 20, 2022

Trade/Device Name: AutoSeg-H Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 21, 2022 Received: June 28, 2022

Dear Jeong Song:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb. Ph.D. Assistant Director DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220039

Device Name AutoSeg-H

Indications for Use (Describe)

AutoSeg-H is medical imaging software that is intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, and right ventricle from CT.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K220039

Image /page/3/Picture/1 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a stylized plus sign or a four-petal flower. To the right of the shape is the text "AiMEDIC" in a gray, sans-serif font, with a red dot above the letter "i".

2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea Tel: +82-(0)2-568-2667 Fax:+82-(0)2-548-2667

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

July 11, 2022

Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.

Name of Manufacturer: AI Medic Inc.
Address: 2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea
Contact Name: Jeong Soon Song/COO
Telephone No.: +82-2-568-2667
Fax No.: +82-2-548-2667
Email Address: song@aimedic.kr

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Common name: Picture archiving and communications system (PACS) Trade name: AutoSeg-H (Model: AutoSeg-H)

Classification Description	21 CFR Section	Product Code
System, Image Processing, Radiological	21 CFR 892.2050	LLZ

As stated in 21 CFR parts 892.2050 of the device has been classified as Class II.

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Image /page/4/Picture/0 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a stylized plus sign or a four-pointed star. To the right of the geometric shape is the text "AiMEDIC" in gray, with a red dot above the "i". The logo appears to be clean and modern.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow:

Predicate device

510(k) Number: K200973 ●
Applicant: FUJIFILM Corporation .
Classification Name: System, Image Processing, Radiological .
Trade Name: Synapse 3D Cardiac Tools
. Common Name: Picture archiving and communications system (PACS)

5. Description of the Device [21 CFR 807.92(a)(4)]

5.1 Overview

AutoSeg-H(V1.0.0.01) is software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. AutoSeg-H(V1.0.0.01) runs on Windows standalone installed on a commercial general-purpose Windows-compatible computer and accepts DICOM compliant medical images acquired from a CT. The AutoSeg-H is not connected to a PACS system directly but retrieves saved image data from a computer. Image data obtained from the computer are used for display, image processing, analysis, etc. AutoSeg-H cannot be used to interpret Mammography images.

The main functions of AutoSeg-H are shown below.

Coronary Artery Analysis (CT) -
Aortic Valve Analysis (CT) -
-4-Chamber Analysis (CT)

5

AutoSeg-H Block Diagram
The connection configurations for AutoSeg-H are shown below.
· AutoSeg-H operates on a window.
· AutoSeg-H reads the CT DICOM image from its own device and analyzes them. (Standalone configuration)

Image /page/5/Figure/6 description: The image shows a diagram of a process flow on a local PC. The process starts with input, which includes Cardiac CT DICOM data and user interaction. The input is then processed, and the output includes 2D images (CPR, Cross-section, Coronary, Aorta, 4-Chamber), 3D images (Coronary, Aorta, 4-Chamber), information (Stenosis Ratio, Measured Information), and an option to export and save the result.

Fig. Block Diagram

AutoSeg-H algorithm description
The software employs an advanced active contour algorithm with entropy regularization, to implement semantic segmentation of target organs. The execution of this method results in 3D reconstruction of target organs.

5.2 AutoSeg-H Applications

In the configurations shown in Block diagram(Fig) offers trained medical professionals the following applications to analyze the image data retrieved from Computed tomography.

General Applications ●
- 1. Menu

In the Menu application, user can import DICOM, load previous work file, extract 3D model, and save work files.

1. 2D Viewer
  The 2D Viewer can show axial view, sagittal view, coronary artery, aorta, and 4-chamber.

6

3D Viewer (3D reconstruction) 3.
The 3D Viewer can show 3D reconstructed coronary artery, aorta, and 4-chamber.
1. Measurement
  The Measurement application can show what the user measured like distance between two points, angle, area. and perimeter of 2D and 3D view etc.
Manual Image Modification (Editing) 5.
By the modification application, users can select, draw, modify, and label specific areas on 2D or 3D view etc. .
1. Sequential Display
  The Sequential Display, sequentially displays a cross section of specified area. (Angle, play range, speed, direction can be set)
1. Setting
  In the Setting application, users can set brightness, initialize histogram, sync images, set 3D reconstruction image as volume, solid mesh and wire frame view, turn on/off patient information, coordinate display, crosshair and 3D view.

7

Analysis Applications
- 1. Coronary Artery Analysis

The Coronary Artery Analysis application can reconstruct 3D Coronary Artery, display Cross section view, analyze Stenosis ratio, initialize the layout and turn on/off the Coronary Artery, Coronary Inner line.

1. Aortic Valve Analysis
  The Aortic Valve Analysis application can reconstruct 3D Aorta, mark the centerline, measure long axis, short axis, area, perimeter, and rotate the 3D image. Also can switch to the default layout, manually select the measurement location, initialize/save/display the measurement result.
1. 4-Chamber Analysis
  The 4-Chamber Analysis application can reconstruct 3D left atrium, left ventricle, right atrium, and right ventricle.

5.3 Technical Characteristics and principles of operations

Predicate Device: A software program used for medical image analysis, of which segmentation method is based on a graphical model for pattern recognition.

Subject Device: A software program used for medical image analysis, of which segmentation method is based on an advanced active contour algorithm for pattern recognition.

Different equations of safety and effectiveness? No

Why: Since both devices receive input data as DICOM compliant CT images and handle it with numerical algorithms, there is no specific reason for raising new or different questions of safety and effectiveness although the new device features different technical characteristics and principles of operations.

8

6. Indications for Use [21 CFR 807.92(a)(5)]

AutoSex-H is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, left ventricle, right atrium, and right ventricle from CT.

9

7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) (6) and 21 CFR 807.92(b)]

The identified predicate device within this submission are shown in the following table:

	Proposed Device	Predicate Device	SE decision
K Number	K220039	K200973	-
Manufacturer	AI Medic Inc.	FUJIFILM Corporation.	-
Trade name	AutoSeg-H	Synapse 3D Cardiac Tools
Model	AutoSeg-H	V5.4
Product Code	LLZ	LLZ	Same
Regulatory Class	Class II	Class II	Same
Regulation Number	21 CFR 892.2050		Same
Indications for Use	AutoSeg-H is medical imaging software
that is intended to provide trained medical
professionals with tools to aid them in
reading, interpreting, reporting, and
treatment planning. AutoSeg-H accepts
DICOM compliant medical images
acquired from imaging device (Computed
Tomography).

AutoSeg-H provides the tools for specific
analysis applications which provide
custom UI, targeted measurements and
reporting functions including:

Coronary Artery Analysis for CT
coronary arteriography images: which is
intended for the qualitative and
quantitative analysis of coronary arteries.
Valve Analysis: which is intended for
automatic extraction of the heart and aorta
regions, automatic detection of the
contour of the aorta and valves,
measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended
for automatic extraction of the left atrium,
left ventricle, right atrium, and right
ventricle from CT. | Synapse 3D Cardiac Tools is medical
imaging software used with Synapse 3D
Base Tools that is intended to provide
trained medical professionals with tools
to aid them in reading interpreting,
reporting, and treatment planning,
Synapse 3D Cardiac Tools accepts
DICOM compliant medical images
acquired from a variety of imaging
devices including, CT, MR, NM, and XA.

This product is not intended for use with
or for the primary diagnostic
interpretation of Mammography images.

Addition to the tools in Synapse 3D Base
Tools, Synapse 3D Cardiac Tools
provides the tools for specific clinical
applications which provide targeted
workflows, custom UI, targeted
measurements and reporting functions
including:

Functional cardiac analysis for CT left
ventriculography images: which is
intended to evaluate the functional
characteristics of heart.
Functional cardiac analysis for MR
heart images: which is intended to
evaluate the functional characteristics of
heart.
Coronary artery analysis for CT
coronary arteriography images which is | Same |
| | | 2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea
Tel: +82-(0)2-568-2667 Fax:+82-(0)2-548-2667
intended for the qualitative and
quantitative analysis of coronary arteries.
Coronary artery analysis for MR heart
images: which is intended for the
qualitative and quantitative analysis of
coronary arteries.
Calcium scoring for non-contrast CT
heart images: which is intended for non-
invasive identification and quantification
of calcified atherosclerotic plaques in the
coronary arteries using tomographic
medical image data and clinically
accepted calcium scoring algorithms.
Cardiac Fusion: which is intended to
analyze cardiac anatomy and pathology
with a fused image of functional data (e.g.
NM image, Bulls eye) and anatomical
data.
Valve Analysis: which is intended for
automatic extraction of the heart and aorta
regions, automatic detection of the
contour of the aorta and valves,
measurement of the vicinity of the valves,
measurement of the calcification area in
the aorta and the valves. Placement of a
virtual prosthetic valve.
MR parametric maps: which is
provided for pixel maps for myocardial
MR relaxation times. | |
| Users | Healthcare Professionals | Healthcare Professionals | Same |
| DICOM compliant
medical images | CT | CT, MR, NM and XA | |
| Imaging Capabilities | 2D, 3D | 2D, 3D | Same |
| Function | Coronary Artery Analysis (CT), Aortic
Valve Analysis (CT), 4-Chamber
Analysis (CT) | Cardiac Function(CT,MR), Coronary
Artery Analysis(CT,MR), Calcium
Scoring, Cardiac Fusion, Aortic Valve
Analysis, MR Flow Analysis(MR), 4-
Chamber Analysis(CT), Cardiac Ablation
Analysis(CT), Cardiac Tx-maps, Mitral
Valve Analysis | |
| Product Availability | Software Product | Software Product | Same |
| Hardware Platform | Windows PC | Windows PC | Same |
| Operating System | Windows 10(x64) | Microsoft Windows 10 (x64, x86)
Microsoft Windows 8.1 (x86, x64) | |

10

DiC AT

2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea

11

Image /page/11/Picture/0 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a stylized plus sign or a four-pointed star. To the right of the shape is the text "AiMEDIC" in gray, with a red dot above the letter "i". The logo appears to be clean and modern, suggesting a company involved in technology or healthcare.

2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea

Tel: +82-(0)2-568-2667 Fax:+82-(0)2-548-2667

		Microsoft Windows 7 Professional (x86, x64) SP1
	Digital Imaging and Communications in
Medicine (DICOM) Set (Ps3.1 - .20)	Digital Imaging and Communications in
Medicine (DICOM) Set (Ps3.1 - .20)
Performance
Standards	AAMI/ANSI/IEC 62304:2006, Medical
Device Software	AAMI/ANSI/IEC 62304:2006, Medical
Device Software	Same
	ISO 14971 Second Edition 2007-03-01,
Medical Devices	ISO 14971 Second Edition 2007-03-01,
Medical Devices
Core Technology and
Algorithm	Segmentation Method Based on
Advanced Active Contour Algorithm

The software employs an advanced active
contour algorithm with entropy
regularization, to implement semantic
segmentation of target organs. The
execution of this method results in 3D
reconstruction of target organs. | The segmentation algorithm is a kind of
graphical model solving energy
minimization problem in terms of
image energies, providing 3D
reconstruction of target organs. | Same |

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

Non-clinical performance testing has been performed in compliance with the following International and FDArecognized consensus standards and FDA guidance document:

ISO 14971 Second Edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices
AAMI/ANSI/IEC 62304:2006, Medical Device Software - Software Life Cycle Processes
Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 - 3.20) (2016)
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Performance tests were conducted for the following purposes:

To confirm that AutoSeg-H meets all performance test criteria and all functions are operating without errors.
To confirm that AutoSeg-H meets test standards which estimation of the quantitative measurement error.
To confirm that AutoSeg-H meets test standards which estimation of segmentation algorithm error.

Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to formalize after ensuring that the software fully satisfies all expected and previously defined system requirements and features.

Through the performance test, it was confirmed that AutoSeg-H meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.

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Image /page/12/Picture/0 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a plus sign made of four diamonds. To the right of the geometric shape is the text "AiMEDIC" in gray, with a red dot above the "i". The logo appears to be for a medical or technology-related company.

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

Conclusion [21 CFR 807.92(b)(3)] 8.

In conclusion, the tests conducted, as well as all verification activities, demonstrate that the design specifications and technological characteristics of AutoSeg-H meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. There are some differences in technological characteristics between the predicates and proposed device, but those differences do not raise new or different questions of safety or effectiveness as compared to the predicate devices. Therefore, AutoSeg-H is substantially equivalent to the currently marketed predicate device.