K Number
K241922
Device Name
Myomics
Manufacturer
Date Cleared
2025-02-28

(242 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Myomics is intended to be used for viewing, post-processing, qualitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; and to view the presence or absence of physician-identified lesion in blood vessels. The target population for manual workflows of Myomics is not restricted; however, semi-automated machine learning algorithms of Myomics are intended for an adult population. The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images. Myomics is used for cardiac images acquired from a 3.0 T MR scanner. Myomics shall be used only for cardiac images acquired from an MR scanner. It shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
Device Description
Myomics is a software application for analysis cardiovascular MR images in DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiovascular MR images qualitatively and quantitatively.
More Information

Not Found

Yes
The "Intended Use" section explicitly mentions "semi-automated machine learning algorithms" and "AI-powered algorithms." The "Indicated Patient Age Range" also specifies that "semi-automated machine learning algorithms of Myomics are intended for an adult population." Furthermore, the "Description of the training set" and "Description of the test set" sections detail the datasets used for training and testing the AI performance, and the "Summary of Performance Studies" discusses the performance of the "machine learning algorithms" and "AI module."

No.
The device is intended for viewing, post-processing, and qualitative evaluation of cardiovascular MR images to assist in diagnosis, not for providing therapy.

Yes

The 'Intended Use / Indications for Use' section explicitly states that the device is for "obtaining diagnostic information as part of a comprehensive diagnostic decision-making process." It also mentions assisting physicians in "qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; and to view the presence or absence of physician-identified lesion in blood vessels." This indicates its role in disease detection and assessment, which are diagnostic functions.

Yes

The device description explicitly states that Myomics is a "software application" and can be used as a "stand-alone product". There is no mention of accompanying hardware components.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
  • Myomics' Function: Myomics analyzes images acquired from a medical imaging modality (MR scanner) of the human body. It processes and evaluates these images to assist physicians in diagnosing conditions. This is an in vivo (within the living body) diagnostic process, not an in vitro one.

Therefore, Myomics falls under the category of medical imaging software or a medical image analysis device, not an IVD.

No
The provided text does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is explicitly marked as "Not Found."

Intended Use / Indications for Use

Myomics is intended to be used for viewing, post-processing, qualitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; and to view the presence or absence of physician-identified lesion in blood vessels. The target population for manual workflows of Myomics is not restricted; however, semi-automated machine learning algorithms of Myomics are intended for an adult population.

The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images.

Myomics is used for cardiac images acquired from a 3.0 T MR scanner.

Myomics shall be used only for cardiac images acquired from an MR scanner. It shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.

Product codes

QIH, LLZ

Device Description

Myomics is a software application for analysis cardiovascular MR images in DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiovascular MR images qualitatively and quantitatively.

Mentions image processing

Yes

Mentions AI, DNN, or ML

The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images.
The target population for manual workflows of Myomics is not restricted; however, semi-automated machine learning algorithms of Myomics are intended for an adult population.
Machine Learning Based Algorithm: Yes (Semi-automatic segmentation)
Quantitative Assessment of Cardiac Function: Yes (Manual segmentation, and semi-automatic segmentation using Machine Learning technique of four heart chambers in short-axis views)
The machine learning algorithms of Myomics were trained and tested using images from various major MR imaging device vendors.
All AI performance testing results met pre-defined acceptance criteria in Phantomics.
The AI performance acceptance criteria, defined using the DICE Score, were applied to evaluate the ML model's effectiveness in segmenting the Myocardium.

Input Imaging Modality

MR

Anatomical Site

Cardiovascular / heart and adjacent vessels / blood vessels

Indicated Patient Age Range

The target population for manual workflows of Myomics is not restricted; however, semi-automated machine learning algorithms of Myomics are intended for an adult population.

Intended User / Care Setting

Myomics shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment.

Description of the training set, sample size, data source, and annotation protocol

The training involved a dataset of 3723 anonymized cases, separate from the test set. This dataset was divided into training, validation, and test sets at a ratio of 80%, 10%, and 10% respectively, yielding 3723 cases for training and 378 cases each for validation and AI performance testing. The data used for AI performance testing was not utilized during the algorithm training process.
The machine learning algorithms of Myomics were trained using images from various major MR imaging device vendors.

Table 4. AI Module Description in Myomics:
AIM-01 Native T1 Map Myocardium Segmentation: 594 cases
AIM-02 Post T1 Map Myocardium Segmentation: 498 cases
AIM-03 T2 Map Myocardium Segmentation: 586 cases
AIM-04 CINE Myocardium Segmentation: 640 cases
AIM-05 LGE PSIR Myocardium Segmentation: 491 cases
AIM-06 CINE RV Myocardium Segmentation: 437 cases
AIM-07 LGE Magnitude Myocardium Segmentation: 477 cases
SUM: 3723 cases

Description of the test set, sample size, data source, and annotation protocol

The AI performance testing dataset originally contained 378 test cases. To improve generalizability and evaluate performance across different MRI manufacturers, 50 additional cases were included per AI module, increasing the total number of test cases from 378 to 728.
Across all MR machine manufacturers n= 728 anonymized patient images were used for the AI performance test of Myomics. This translates into 92 cases for Native T1 Map Myocardium Segmentation, 91 cases for Post T1 Map Myocardium Segmentation, 109 cases for T2 Map Myocardium Segmentation, 90 cases for CINE Map Myocardium Segmentation, 77 cases for LGE PSIR Myocardium Segmentation, 192 cases for CINE RV Myocardium Segmentation, and 77 cases for LGE Magnitude Myocardium Segmentation.
The data used for AI performance testing was not utilized during the algorithm training process.
The machine learning algorithms of Myomics were tested using images from various major MR imaging device vendors.

Summary of Performance Studies

Study type: A bench performance test was conducted to verify the substantial equivalence in performance between the subject device (Myomics) and the predicate device (Myomics Q). It was also conducted to compare the segmentation function (endocardium and epicardium contour) between the subject device (Myomics) and the secondary predicate device (cvi42 auto).
Validation of AI Modules: The machine learning algorithms of Myomics were trained and tested using images from various major MR imaging device vendors.
Sample size: 728 anonymized patient images for AI performance test. (92 for Native T1, 91 for Post T1, 109 for T2, 90 for CINE Myocardium, 77 for LGE PSIR, 192 for CINE RV, 77 for LGE Magnitude).
Key results: The bench performance test confirmed the substantial equivalence of the subject device (Myomics) to both predicate devices (cvi42 auto and Myomics Q). Upon evaluating the performance of each AI module used in Myomics, all modules attained an average DICE Score of over 0.7. All AI performance testing results met pre-defined acceptance criteria in Phantomics.

Key Metrics

DICE Score: All modules attained an average DICE Score of over 0.7.

Predicate Device(s)

K211432, K213998

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 28, 2025

Phantomics Inc. Soeun Baek Manager 152, Magokseo-ro, Gangseo-gu A-609 Seoul, 07788 Korea, South

Re: K241922

Trade/Device Name: Myomics Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: January 21, 2025 Received: January 21, 2025

Dear Soeun Baek:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

2

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,

Samuel for

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: 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) K241922

Device Name Myomics

Indications for Use (Describe)

Myomics is intended to be used for viewing, post-processing, qualitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; and to view the presence or absence of physician-identified lesion in blood vessels. The target population for manual workflows of Myomics is not restricted; however, semi-automated machine learning algorithms of Myomics are intended for an adult population.

The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images.

Myomics is used for cardiac images acquired from a 3.0 T MR scanner.

Myomics shall be used only for cardiac images acquired from an MR scanner. It shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/1 description: The image shows the logo for "PHANTOMICS". The logo consists of a circular icon with a stylized human face inside, positioned to the left of the company name. The text "PHANTOMICS" is written in a bold, sans-serif font, and the entire logo is colored in a bright blue hue.

K241922

Image /page/4/Picture/3 description: The image shows a logo for "PHANTOMICS". The logo consists of the word "PHANTOMICS" in blue, arranged vertically along the left side of a blue circle. Inside the circle is a stylized face with closed eyes, a nose, and a smiling mouth, all rendered in the same blue color as the circle and text. The overall design is simple and clean, with a focus on the company name and a minimalist representation of a face.

The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act 1990 and 21 CFR 807.92(c).

Date: May 21, 2024

l. SUBMITTER

  • Submitter Name: Phantomics Inc.
  • Address: A-609, 152, Magokseo-ro, Gangseo-gu, Seoul, Republic of Korea
  • Data Prepared: May 21 2024
  • I Telephone Number: +82-10-5755-2840
  • I Contact Person: Soeun Baek
  • Email: soeunbaek@phantomics.io

II. DEVICE

  • Device's Trade Name: Myomics
  • Device's Common Name: Automated Radiological Image Processing Software
  • I Regulation Number: 21CFR 892.2050
  • Primary Product Code: QIH
  • Secondary Product Code: LLZ
  • Device Class: 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)
  • I Classification Panel: Radiology

lll. PREDICATE DEVICE

The primary predicate is Myomics Q (K211432) manufactured by Phantomics Inc. The cvi42 Auto Imaging Software Application (K213998), manufactured by Circle Cardiovascular Imaging Inc. is used as a secondary predicate device. The predicate devices have not been subject to design-related recall.

IV. SUBJECT DEVICE DESCRIPTION

Myomics is a software application for analysis cardiovascular MR images in DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiovascular MR images qualitatively and quantitatively.

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Image /page/5/Picture/1 description: The image shows the logo for "PHANTOMICS". The logo consists of a stylized head with three curved lines above it, followed by the word "PHANTOMICS" in blue, sans-serif font. The logo is simple and modern.

V. INTENDED USE

Viewing, post-processing, qualitative and quantitative evaluation of blood vessels and cardiovascular MR images in DICOM format.

VI. INDICATIONS FOR USE

The Indications for Use statement for the Myomical to the predicate device; the differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate.

Table 1. Comparison to the predicate devices
Subject DevicePrimary DeviceReference Device
MyomicsMyomics Q (K211432)cvi42 Auto (K213998)
Manufactured by PhantomicsManufactured by PhantomicsManufactured by Circle
Indication
for useMyomics is intended to be used for viewing, post-
processing, qualitative and quantitative evaluation
of cardiovascular magnetic resonance (MR)
images in a Digital Imaging and Communications
in Medicine (DICOM) standard format.Myomics Q is intended to be used for viewing,
post-processing and analysis of cardiac magnetic
resonance (MR) images in a Digital Imaging and
Communications in Medicine (DICOM) Standard
format. It enables:cvi42 Auto is intended to be used for
viewing, post-processing, qualitative and
quantitative evaluation of cardiovascular
magnetic resonance (MR) and computed
tomography (CT) images in a Digital Imaging
and Communications in Medicine (DICOM)
Standard format.
It enables a set of tools to assist physicians in
qualitative assessment of cardiac images and
quantitative measurements of the heart and
adjacent vessels; and to view the presence or
absence of physician-identified lesion in blood
vessels.- Importing cardiac MR images in DICOM format.
  • Supporting clinical diagnostics by analysis of
    cardiac MR images using display functionality such
    as panning, windowing, zooming through
    series/slices of the images.
  • Supporting clinical diagnostics analysis of the
    heart in cardiac MR images and signal intensity.
  • Software package is designed to support the
    physician-to-physician compliance assessment,
    document and follow up heart disease by cardiac
    MRI. | It enables a set of tools to assist physicians in
    qualitative assessment of cardiac images and
    quantitative measurements of the heart and
    adjacent vessels; perform calcium scoring;
    and to confirm the presence or absence of
    physician-identified lesion in blood vessels. |
    | | The target population for manual workflows of
    Myomics is not restricted; however, semi-
    automated machine learning algorithms of
    Myomics are intended for an adult population. | It shall be used by qualified medical professionals,
    experienced in examining and evaluating
    cardiovascular MR images, for the purpose of
    obtaining diagnostic information as part of a
    comprehensive diagnostic decision-making process. | The target population for cvi42 Auto's
    manual workflows is not restricted; however,
    cvi42 Auto's semi-automated machine
    learning algorithms are intended for an adult
    population. |
    | | The software comprises various analysis modules,
    including Al-powered algorithms, for a
    comprehensive evaluation of MR images. | This device is a software application that can be
    used as a stand-alone product or in a network
    environment. | cvi42 Auto shall be used only for cardiac
    images acquired from an MR or CT scanner.
    It shall be used by qualified medical
    professionals, experienced in examining and
    evaluating cardiovascular MR or CT images, |
    | | Myomics is used for cardiac images acquired
    from a 3.0 T MR scanner. | | |

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Image /page/6/Picture/1 description: The image shows the logo for "PHANTOMICS". The logo consists of a circular icon with three stylized figures inside, positioned above the text "PHANTOMICS". The text is in a sans-serif font and is colored in blue. The logo appears to be for a company or organization named "PHANTOMICS".

Subject DevicePrimary DeviceReference Device
-Myomics
Manufactured by PhantomicsMyomics Q (K211432)
Manufactured by Phantomicscvi42 Auto (K213998)
Manufactured by Circle
Myomics shall be used only for cardiac images
acquired from an MR scanner. It shall be used by
qualified medical professionals, experienced in
examining and evaluating cardiovascular MR
images, for the purpose of obtaining diagnostic
information as part of a comprehensive diagnostic
decision-making process.The target population for the device is not
restricted, however the image acquisition by a
cardiac MR scanner may limit the use of the device
for certain sectors or the public.for the purpose of obtaining diagnostic
information as part of a comprehensive
diagnostic decision-making process.

VII. SUBSTANTIAL EQUIVALENCE

-Subject DevicePrimary DeviceReference Device
Device NameMyomicsMyomics Qcvi42 Auto Imaging Software Application
510(k) Number-K211432K213998
ManufacturerPhantomics Inc.Phantomics Inc.Circle Cardiovascular Imaging Inc.
Regulation Number21CFR892.205021CFR892.205021CFR892.2050
Regulation NamePicture Archiving and Communication SystemPicture Archiving and Communication SystemPicture Archiving and Communication System
ClassificationClass IIClass IIClass II
Product CodeQIHLLZQIH

Table 2. General comparison to the predicate devices

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Image /page/7/Picture/1 description: The image contains the logo for the company "PHANTOMICS". The logo consists of a stylized face above the company name. The text is in a sans-serif font and is colored blue.

Table 3. Feature comparison table of Myomics with the predicate devices
-Subject DevicePrimary DeviceReference Device
Myomics
Manufactured by PhantomicsMyomics Q (K211432)
Manufactured by Phantomicscvi42 Auto (K213998)
Manufactured by Circle
Imaging ModalitiesMRMRMR and CT
Imaging TypeCardiovascularCardiovascularCardiovascular
DICOM Compliant
NetworkingYesYesYes
Import and Display
MR imagesYesYesYes
Images can be
displayed by study
and seriesYesYesYes
Segmentation of
regions of interestYes (Endocardium and epicardium contour
segmentation)Yes (Endocardium and epicardium contour
segmentation)Yes (Endocardium and epicardium contour
segmentation)
Store imagesYes (File Format: dcm, json, nii, csv)Yes (File Format: dcm, json, nii, csv)Yes (File Format: PDF, XML)
Machine Learning
Based AlgorithmYes (Semi-automatic segmentation)NoYes (Semi-automatic segmentation)
Quantitative
Assessment of
Cardiac FunctionYes (Manual segmentation, and semi-
automatic segmentation using Machine
Learning technique of four heart chambers in
short-axis views)Yes (Manual segmentation)Yes (Manual segmentation, and semi-
automatic segmentation using Machine
Learning technique of four heart chambers in
long and short-axis views)
Operating SystemMicrosoft WindowsMicrosoft WindowsMac OS and Microsoft Windows
Software
Development
StandardIEC 62304:2006+A1:2015IEC 62304:2006+A1:2015IEC 62304:2006+A1:2015
Risk Management
StandardISO 14971:2019ISO 14971:2007ISO 14971:2019
Table 3. Feature comparison table of Myomics with the predicate devices

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Image /page/8/Picture/1 description: The image shows the logo for "PHANTOMICS". The logo consists of a stylized head with three curved lines above the word "PHANTOMICS". The word "PHANTOMICS" is written in a sans-serif font and is in blue. The logo is simple and modern.

VIII. PERFORMANCE DATA AND TESTING

1) Performance Test

A bench performance test was conducted to verify the substantial equivalence in performance between the subject device (Myomics) and the predicate device (Myomics Q). These devices analyze cardiovascular MR images and have general worklist functions such as importing, exporting images, manually drawing contours, and reporting. It was also conducted to compare the segmentation function (endocardium and epicardium contour) between the subject device (Myomics) and the secondary predicate device (cvi42 auto). The bench performance test confirmed the substantial equivalence of the subject device (Myomics) to both predicate devices (cvi42 auto and Myomics Q).

2) Verification and validation

Software verification and validation of Subject device (Myomics) has been tested according to "ISO 13485:2016', "IEC 62304:2015" and "ISO 14971:2019" .and all documents have been made according to the Software Development Plan of Myomics.

3) Validation of AI Modules

The machine learning algorithms of Myomics were trained and tested using images from various major MR imaging device vendors. The data used for AI performance testing was not utilized during the algorithm training process. The training involved a dataset of 3723 anonymized cases, separate from the test set. This dataset was divided into training, validation, and test sets at a ratio of 80%, 10%, and 10% respectively, yielding 3723 cases for training and 378 cases each for validation and AI performance testing.

The AI performance testing dataset originally contained 378 test cases. To improve generalizability and evaluate performance across different MRI manufacturers, 50 additional cases were included per AI module, increasing the total number of test cases from 378 to 728.

AI Module No.Data Group (AI Model Name)TrainingValidationTest
AIM-01Native T1 Map Myocardium Segmentation594 cases42 cases92 cases
AIM-02Post T1 Map Myocardium Segmentation498 cases41 cases91 cases
AIM-03T2 Map Myocardium Segmentation586 cases59 cases109 cases
AIM-04CINE Myocardium Segmentation640 cases40 cases90 cases
AIM-05LGE PSIR Myocardium Segmentation491 cases27 cases77 cases
AIM-06CINE RV Myocardium Segmentation437 cases142 cases192 cases
AIM-07LGE Magnitude Myocardium Segmentation477 cases27 cases77 cases
SUM3723 cases378 cases728 cases

Table 4. AI Module Description in Myomics

Across all MR machine manufacturers n= 728 anonymized patient images were used for the AI performance test of Myomics. This translates into 92 cases for Native T1 Map Myocardium Segmentation, 91 cases for Post T1 Map Myocardium Segmentation, 109 cases for T2 Map Myocardium Segmentation, 90 cases for CINE Map Myocardium Segmentation, 77 cases for LGE PSIR Myocardium Segmentation, 192 cases for CINE RV Myocardium Segmentation, and 77 cases for LGE Magnitude Myocardium Segmentation. All AI performance testing results met pre-defined acceptance criteria in Phantomics.

The AI performance acceptance criteria, defined using the DICE Score, were applied to evaluate the ML model's effectiveness in segmenting the Myocardium. The DICE Score is a common metric used in computer vision and medical imaging to measure the similarity or overlap between two sets. It is typically used in image segmentation and object detection. Upon evaluating the performance of each AI module used in Myomics, all modules attained an average DICE Score of over 0.7. All data and results from the AI performance test have been documented in accordance with quality system of Phantomics.

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IX.CONCLUSION

In comparing substantial equivalence between the subject device and the predicate device, similarities are found in general, technical and material information. Despite some differences, the safety and performance test reports affirm the safety and effectiveness of the subject device. Therefore, we conclude that the subject device is substantially equivalent to the predicate device. The information provided in this premarket notification, which includes performance testing and comparisons with the predicate devices, attests to the safety and effectiveness of Myomics for its intended use.