K Number
K232613
Device Name
CT Cardiomegaly
Manufacturer
Date Cleared
2024-02-28

(184 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CT Cardiomegaly is a command line software application intended to be run on its own or as part of another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart. CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning algorithm. Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults and transitional adolescents (18 to 21 years old but treated as an adult). Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease.
Device Description
The CT Cardiomegaly application is a software only (SaMD) medical device which includes automated algorithms and non-adaptive machine learning to analyze chest computed tomography (CT) images. CT Cardiomegaly is a command line software intended to be run on its own or as part of another medical device. CT Cardiomegaly scans the existing images for the presence of specific anatomical structures (i.e., heart and chest cavity). If the target structures are present, the software segments and performs automated measurements which may be helpful in assisting with the detection of certain diseases and/or conditions (i.e., cardiomegaly). The quantitative information is provided to the clinician in the form of a summary report. The clinician (using all available information) then decides if further diagnostic work-up, analysis or measurements are indicated. The results from CT Cardiomegaly are not intended to be used as the primary input for clinicaldecision making or diagnosis. A reference standard was created to train the machine learning algorithms in CT Cardiomegaly. Data for training and testing were sampled from this database based on exclusion criteria. Data was also selected to ensure no site was shared by training and testing cohorts. The training dataset included 1600 unique patient cases from 267 unique sites across 20 U.S. states.
More Information

Not Found

Yes
The device description explicitly states that it includes "non-adaptive machine learning" and that a "reference standard was created to train the machine learning algorithms".

No.
Explanation: The device is designed to measure and calculate the cardiothoracic ratio from CT images to assist in detecting conditions like cardiomegaly, not to treat or alleviate a disease or condition.

No
The device is intended to assist with the detection of certain diseases and/or conditions (i.e., cardiomegaly) by providing quantitative information to the clinician. However, the text explicitly states that its results are "not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease" and "not intended to be used as the primary input for clinical-decision making or diagnosis." This indicates it's an assistive tool rather than a standalone diagnostic device.

Yes

The device description explicitly states "The CT Cardiomegaly application is a software only (SaMD) medical device".

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
  • Device Function: The CT Cardiomegaly software analyzes medical images (CT scans), not biological specimens. It performs measurements and calculations based on the visual information within the image.
  • Intended Use: The intended use is to automatically calculate cardiothoracic ratio from a CT image. While this information can be helpful in assisting with the detection of certain conditions, it is explicitly stated that the results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease. This further reinforces that it's an image analysis tool providing quantitative data, not a diagnostic test performed on a biological sample.

Therefore, the CT Cardiomegaly software falls under the category of a medical device that performs image analysis and provides quantitative information to aid clinicians, but it does not meet the definition of an In Vitro Diagnostic.

No
The document does not explicitly state that the FDA reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The "Control Plan Authorized (PCCP)" section is marked "Not Found," and there is no other language indicating such approval or clearance.

Intended Use / Indications for Use

CT Cardiomegaly is a command line software application intended to be run on its own or as part of another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart.

CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning algorithm.

Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.

The system is suitable for adults and transitional adolescents (18 to 21 years old but treated as an adult).

Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease.

Product codes

OIH

Device Description

The CT Cardiomegaly application is a software only (SaMD) medical device which includes automated algorithms and non-adaptive machine learning to analyze chest computed tomography (CT) images. CT Cardiomegaly is a command line software intended to be run on its own or as part of another medical device.

CT Cardiomegaly scans the existing images for the presence of specific anatomical structures (i.e., heart and chest cavity). If the target structures are present, the software segments and performs automated measurements which may be helpful in assisting with the detection of certain diseases and/or conditions (i.e., cardiomegaly). The quantitative information is provided to the clinician in the form of a summary report. The clinician (using all available information) then decides if further diagnostic work-up, analysis or measurements are indicated.

The results from CT Cardiomegaly are not intended to be used as the primary input for clinicaldecision making or diagnosis.

A reference standard was created to train the machine learning algorithms in CT Cardiomegaly. Data for training and testing were sampled from this database based on exclusion criteria. Data was also selected to ensure no site was shared by training and testing cohorts. The training dataset included 1600 unique patient cases from 267 unique sites across 20 U.S. states.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Mentions artificial intelligence and machine learning.

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

Chest

Indicated Patient Age Range

Adults and transitional adolescents (18 to 21 years old but treated as an adult)

Intended User / Care Setting

Physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.

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

Data for training (1600 cases) was sampled from a database curated by the University of Alabama at Birmingham of over 8,000 imaging studies from over 300 unique imaging sites. Data was also selected to ensure no site was shared by training and testing cohorts. The training dataset included 1600 unique patient cases from 267 unique sites across 20 U.S. states. A reference standard was created to train the machine learning algorithms.

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

Data for testing (275 cases) was sampled from a database curated by the University of Alabama at Birmingham of over 8,000 imaging studies from over 300 unique imaging sites. Data was also selected to ensure no site was shared by training and testing cohorts. The testing dataset included 275 unique patients cases from sites across 12 U.S. states. Subgroups and confounders present in the dataset included patient demographics (age, sex, race, ethnicity), confounding conditions, and imaging characteristics (protocol, slice thickness, scanner manufacturer, presence or absence of contrast, kVp). Images were representative of numerous scanner manufacturers (e.g., GE, Siemens, Philips, Canon Medical Systems, Toshiba, Siemens Healthineers, United Imaging Healthcare) and imaging protocols (i.e., abdominal CT, chest CT, PET/CT and high-resolution chest CT). The data consisted of 142 male and 133 female patients of different ethnicities aged 18-96 (median 62) years. The reference standard for this assessment was established by three board-certified radiologists, each providing a segmentation for the heart and the inner chest independently.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing, technical performance assessment.
Sample size: 275 unique patients cases for testing.
Primary Endpoints: Calculating the difference between the average measurement of the human readers and the subject device's measurement. Clinical performance testing showed strong agreement with physician-derived measurements, with an average difference less than 0.01. The 95% limits of agreement were [-0.033, 0.035] for Cardiothoracic Ratio and [-0.028, 0.035] for Heart to Chest Area Ratio.
Secondary Endpoints: Precision of selecting the slice where the heart area is the largest (key heart slice detection) and the accuracy of heart and inner chest segmentations. Key Slice Position Mean Difference: 0.46 mm. Observed Dice for Heart: 0.95 (0.950, 0.956). Observed Dice for Inner Chest: 0.98 (0.982, 0.984).

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

Mean Absolute Difference for Cardiothoracic Ratio: 0.009 [0.007, 0.011]
Mean Absolute Difference for Heart to Chest Area Ratio: 0.009 [0.007, 0.010]
Mean Difference for Cardiothoracic Ratio: 0.0012 [-0.0008, 0.0033]
Mean Difference for Heart to Chest Area Ratio: 0.0036 [0.0017, 0.0055]
Standard Deviation of Differences for Cardiothoracic Ratio: 0.0172
Standard Deviation of Differences for Heart to Chest Area Ratio: 0.0161
Mean Difference for Key Slice Position: 0.46 mm [-0.49, 1.41]
Standard Deviation of Differences for Key Slice Position: 0.49 mm
Observed Dice for Heart: 0.95 [0.950, 0.956]
Observed Dice for Inner Chest: 0.98 [0.982, 0.984]

Predicate Device(s)

K212624

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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February 28, 2024

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Innolitics, LLC % Meritxell Martinez Project Manager and Regulatory Specialist 1101 West 34th St Austin, Texas 78705

Re: K232613

Trade/Device Name: CT Cardiomegaly Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OIH Dated: January 30, 2024 Received: January 30, 2024

Dear Meritxell Martinez:

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.

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).

1

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 (QS) 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.

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 mediation-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,

Samul Zik 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

2

Indications for Use

510(k) Number (if known) K232613

Device Name CT Cardiomegaly

Indications for Use (Describe)

CT Cardiomegaly is a command line software application intended to be run on its own or as part of another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart.

CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning algorithm.

Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.

The system is suitable for adults and transitional adolescents (18 to 21 years old but treated as an adult).

Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K232613

1. ADMINISTRATIVE INFORMATION

Submitter NameInnolitics LLC
Address1101 West 34th St #550, Austin, TX 78705, US
Phone Number+1 (512) 967-6088
Fax NumberN/A
Company RepresentativeMeritxell Martinez
Additional Company RepresentativesYujan Shrestha, MD
Ethan Ulrich
Andrew Smith, MD, PhD
Steven Rothenberg, MD
Jim Luker, RN, MS
Emailfda@innolitics.com
Date Summary PreparedJanuary 30th, 2024
Documentation Prepared UsingInnolitics Medtech OS Framework

2. SUBJECT DEVICE INFORMATION

Trade NameCT Cardiomegaly
Subject Device K NumberK232613
Common NameAutomated Radiological Image Processing Software
Product CodeQIH
Regulation Number892.2050
Regulatory ClassClass II
Review PanelRadiology

Image /page/3/Picture/7 description: The image contains the logo for Innolitics SaMD Simplified. The logo consists of a blue hexagon-like shape on the left, followed by the text "Innolitics" in a bold, blue font. Below "Innolitics" is the text "SaMD Simplified" in a smaller, lighter blue font. The logo is clean and professional, suggesting a company in the technology or software industry.

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3. PREDICATE DEVICE INFORMATION

Predicate Device NameEFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Predicate Device K NumberK212624
Common NameEFAI iCTR
Product CodeQIH
Regulation Number892.2050
Regulatory ClassClass II
Review PanelRadiology

4. DEVICE DESCRIPTION

The CT Cardiomegaly application is a software only (SaMD) medical device which includes automated algorithms and non-adaptive machine learning to analyze chest computed tomography (CT) images. CT Cardiomegaly is a command line software intended to be run on its own or as part of another medical device.

CT Cardiomegaly scans the existing images for the presence of specific anatomical structures (i.e., heart and chest cavity). If the target structures are present, the software segments and performs automated measurements which may be helpful in assisting with the detection of certain diseases and/or conditions (i.e., cardiomegaly). The quantitative information is provided to the clinician in the form of a summary report. The clinician (using all available information) then decides if further diagnostic work-up, analysis or measurements are indicated.

The results from CT Cardiomegaly are not intended to be used as the primary input for clinicaldecision making or diagnosis.

A reference standard was created to train the machine learning algorithms in CT Cardiomegaly. Data for training and testing were sampled from this database based on exclusion criteria. Data was also selected to ensure no site was shared by training and testing cohorts. The training dataset included 1600 unique patient cases from 267 unique sites across 20 U.S. states.

Image /page/4/Picture/9 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left, followed by the word "Innolitics" in large, bold, blue font. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, lighter blue font. The logo is clean and modern, with a focus on simplicity and clarity.

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5. INDICATIONS FOR USE

CT Cardiomegaly is a command line software application intended to be run on its own or as part of another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart.

CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning algorithm.

Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.

The system is suitable for adults and transitional adolescents (18 to 21 years old but treated as an adult).

Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease.

5.1. Indications for Use Equivalence Discussion

Both the subject (CT Cardiomegaly) and predicate device (EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System) have similar indications for use, with the exception that the subject device analyzes CT images while the predicate device is limited to X-ray images.

Another difference between the indications for use for both devices is that the predicate uses an artificial intelligence algorithm using an unknown framework while the subject device utilizes a non-adaptive machine learning algorithm using the MONAI framework.

However, these are differences in technological characteristics that do not affect safety and effectiveness of the device, and have been supported with appropriate verification and validation testing.

| Characteristic | CT Cardiomegaly | EFAI Intelligent
Cardiothoracic Ratio
(iCTR) Assessment
System (K212624) | Substantial Equivalence Discussion |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Innolitics LLC | Ever Fortune. AI Co.,
Ltd. | N/A |
| Characteristic | CT Cardiomegaly | EFAI Intelligent
Cardiothoracic Ratio
(iCTR) Assessment
System (K212624) | Substantial Equivalence Discussion |
| Regulation
Number | 892.2050 | 892.2050 | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | QIH | QIH | Same |
| Regulation Name | Medical image processing
and management system | Medical image processing
and management system | Same |
| Device Property | SaMD | SaMD | Same |
| Intended Use/
Indications for Use | CT Cardiomegaly is
software intended to be run
on its own or as part of
another medical device to
automatically calculate
linear and area based
cardiothoracic ratio (CTR)
from a CT image
containing the heart.
CT Cardiomegaly is
designed to measure the
maximal transverse
diameter of heart and
maximal inner transverse
diameter of thoracic cavity
and calculate the CTR from
an axial CT slice
containing the heart using a
non-adaptive machine
learning algorithm.
Intended users of the
software are aimed to the
physicians or other
licensed practitioners in the
healthcare institutions,
such as clinics, hospitals,
healthcare facilities,
residential care facilities
and long-term care
services.
The system is suitable for
adults and transitional
adolescents (18 to 21 years
old but treated as an adult).
Its results are not intended
to be used on a stand-alone
basis for clinical-decision | EFAI Intelligent
Cardiothoracic Ratio
Assessment System (or
iCTR) is a software for use
by hospital and clinics to
automatically assess the
cardiothoracic ratio (CTR)
of a chest X-ray image from
the X-ray imager subject.
The iCTR is designed to
measure the maximal
transverse diameter of heart
and maximal inner
transverse diameter of
thoracic cavity and calculate
the CTR of a chest X-ray
image in posterior-anterior
(PA) chest view using an
artificial intelligence
algorithm.
Intended users of the
software are aimed to the
physicians or other licensed
practitioners in the
healthcare institutions, such
as clinics, hospitals,
healthcare facilities,
residential care facilities and
long-term care services.
The system is suitable for
adults between 20 - 80 years
of age.
Its results are not intended
to be used on a stand-alone
basis for clinical-decision
making or otherwise
preclude clinical assessment | Both the subject (CT Cardiomegaly)
and predicate device (iCTR) have
identical indications for use, with the
exception that the subject device
analyzes CT images while the predicate
device is limited to X-ray images.
Another difference between the
indications for use for both devices is
that the predicate uses artificial
intelligence algorithms using an
unknown framework while the subject
device utilizes non-adaptive machine
learning algorithms using the MONAI
framework.
However, these differences in
technological characteristics do not
affect safety and effectiveness of the
device, and have been supported with
verification and validation testing. |
| Characteristic | CT Cardiomegaly | EFAI Intelligent
Cardiothoracic Ratio
(iCTR) Assessment
System (K212624) | Substantial Equivalence Discussion |
| | making or otherwise
preclude clinical
assessment of any disease. | of cardiothoracic ratio
(CTR) cases. | |
| Technical
Characteristics | | | |
| Input | CT image study | Post-anterior (PA) view
chest X-ray image | The input for the predicate device is a
2-dimensional chest X-ray image, while
the subject device's input is an entire
CT study. The subject device will select
out of the CT study an axial slice
containing the heart, if present, and
perform measurements. The main
difference is that the predicate operates
on images that are post-anterior (PA)
view chest X-ray, while the subject
device's operates on images that are
axial CT. Nonetheless, this difference
in imaging modality does not raise any
new concerns and has been verified and
validated in testing. |
| Output files | PDF and JSON Reports | Reports, DICOM
Secondary Capture
series | The output format of the predicate
device includes reports and DICOM
secondary capture series, while the
subject device's only output format is a
report (in both PDF and JSON format).
Thus, the subject device's output
format is a subset of the predicate's
available output formats (i.e., report).
This lack of a feature does not raise any
new concerns. |
| Output
measurements | Linear-based CTR and
area-based CTR | Linear-based CTR | The predicate device outputs a linear-
based CTR measurement while the
subject device outputs both linear and
area-based CTR measurements.
Although this output measurement of
area-based CTR is not included in the
predicate device, it does not raise
different questions of safety or
effectiveness and has been properly
verified and validated in testing. |
| Report Structure | Report will be output in
the PDF and JSON
file format which is
structured with following | Report will be output in
the DICOM and JSON
file format which is
structured with following | Both devices produce reports that
output CTR and patient information.
One of the main differences between
both devices is that the predicate only |
| Characteristic | CT Cardiomegaly | EFAI Intelligent
Cardiothoracic Ratio
(iCTR) Assessment
System (K212624) | Substantial Equivalence Discussion |
| | information:

  1. CTR (both linear and
    area-based)
  2. Patient information
  3. Reference value(s) | information and function
    tool:
  4. CTR
  5. adjustable annotation line
    (maximal inner border
    diameter of thoracic cavity
    and maximal diameter of
    heart)
  6. the trajectory of CTR
    (including chest X-ray)
  7. Patient information | has one CTR output, while the subject
    device outputs both linear-based CTR
    and area-based CTR. This difference is
    further discussed in the row above.
    Additionally, the predicate device
    presents the feature to modify the
    annotation line, which is not available
    in the subject device. However, CT
    Cardiomegaly 's indications for use
    explicitly state that the results produced
    by the device are not intended to be
    solely relied upon for clinical decision-
    making, nor do they replace the need
    for clinical assessment of any disease.
    Furthermore, the user manual of the
    device contains instructions mandating
    healthcare professionals to review the
    results presented in the report.
    Both devices produce reports that
    contain relevant patient information.
    The predicate device includes a
    trajectory of the CTR in the report. The
    subject device includes segmentations
    of the heart area and inner chest area.
    Lastly, the subject device introduces a
    feature to have user-specified reference
    value(s) stated in the report. The
    healthcare professional is able to set
    reference value(s) linear and area-based
    CTR, based on published literature or
    their practice of medicine. This feature
    is not found in the predicate device, but
    has been properly verified and
    validated. |
    | Intended Users | Physicians or other
    licensed practitioners in
    the healthcare
    institutions | Physicians or other
    licensed practitioners in
    the healthcare
    institutions | Same |
    | Target Population | Adults and transitional
    adolescents (18 to 21 years
    old but treated as an adult)" | Adults of 20-80 years old | Both devices have similar intended
    target populations. The subject device's
    patient population age range has been
    supported by appropriate performance
    testing. |
    | Characteristic | CT Cardiomegaly | EFAI Intelligent
    Cardiothoracic Ratio
    (iCTR) Assessment
    System (K212624) | Substantial Equivalence Discussion |
    | Location of
    anatomical
    structures | Chest | Chest | Same |
    | Imaging Modality | Computed Tomography
    (CT) | Chest X-ray in Digital
    Radiography (DR) | Although the predicate and subject
    device are compatible with different
    imaging modalities, this technological
    difference does not raise new questions
    of safety or effectiveness. Additionally,
    this difference has been properly
    supported with verification and
    validation testing. |
    | Intended Use
    Environment | Healthcare institutions
    (Clinics, hospitals,
    healthcare facilities,
    residential care facilities
    and long-term care
    services) | Healthcare institutions
    (Clinics, hospitals,
    healthcare facilities,
    residential care facilities
    and long-term care
    services) | Same |
    | Software device
    that
    operates on off-the-
    shelf
    hardware | Yes | Yes | Same |
    | Software devices
    uses
    software
    algorithms for
    image | Yes | Yes | Same |
    | Diameter
    Measurement | Yes - Automated | Yes - Automated | Same, with the main difference that
    diameter measurements are performed
    on an axial slice of the CT series for the
    subject device (not on chest x-ray, as
    done for the predicate). |
    | Storage | Saved in JSON and
    PDF file format | Saved in JSON and
    DICOM file format text
    for DICOM and
    DICOM file format | Both devices store study reports in
    machine-readable JSON format.
    The predicate device also stores files in
    DICOM format. On the other hand, the
    subject device also outputs reports in
    PDF format. This difference in file
    format does not raise any new questions
    of safety or effectiveness, and is |
    | Characteristic | CT Cardiomegaly | EFAI Intelligent
    Cardiothoracic Ratio
    (iCTR) Assessment
    System (K212624) | Substantial Equivalence Discussion |
    | | | | supported by verification and validation
    testing. |
    | Software
    Requirement | Ubuntu 20.04.5 LTS
    (provided as a Docker
    container)
    Docker 23.0.1 or above | Ubuntu 18.04
    (Web browser :
    chrome 88.0.4324.182
    or above) | Both devices have similar software
    requirements. The subject device
    requires a newer version of the
    operating system that runs inside a
    container. The main difference is that
    the predicate device is intended to run
    on a web browser while the subject
    |
    | Algorithm type | Machine learning based
    algorithm (non-adaptive) | Artificial Intelligence | Same. Machine learning based
    algorithm is a subset of artificial
    intelligence. |

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Image /page/5/Picture/14 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon made up of smaller triangles on the left, and the word "Innolitics" in a bold, blue font on the right. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, blue font.

6

Image /page/6/Picture/0 description: The image contains the logo for "Body Check". The logo consists of a green and blue check mark inside of a circle. The text "Body" is in green and the text "Check" is in blue.

Image /page/6/Picture/3 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left, followed by the word "Innolitics" in a bold, blue font. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, lighter blue font. The logo is clean and modern, with a focus on simplicity and clarity.

7

Image /page/7/Picture/0 description: The image contains the logo for "Body Check". The logo consists of a green and blue check mark on the left side of the image. The words "Body Check" are on the right side of the image, with "Body" in green and "Check" in blue.

Image /page/7/Picture/3 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon shape on the left, with the word "Innolitics" in bold, blue letters to the right of the hexagon. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, blue font.

8

Image /page/8/Picture/0 description: The image contains the logo for "Body Check". The logo consists of a green and blue check mark on the left side of the image. The words "Body Check" are on the right side of the image, with "Body" in green and "Check" in blue.

Image /page/8/Picture/3 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left, followed by the word "Innolitics" in a bold, blue font. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, lighter blue font. The logo is clean and modern, with a focus on simplicity and clarity.

9

Image /page/9/Picture/0 description: The image shows the logo for "Body Check". The logo consists of a green and blue check mark on the left, followed by the words "Body Check" in green and blue. The word "Body" is in green, and the word "Check" is in blue.

Image /page/9/Picture/3 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left, with the word "Innolitics" in bold, blue letters to the right of the shape. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, lighter blue font.

10

Image /page/10/Picture/0 description: The image shows the logo for Body Check. The logo consists of a green circle with a white checkmark inside, and the words "Body Check" in green and blue. The word "Body" is in green, and the word "Check" is in blue.

7. PERFORMANCE DATA

7.1. Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions".

The software verification and validation testing verified that the design requirements were successfully met. The Intended use and user needs were successfully validated.

As the intended use, functionality and performance of CT Cardiomegaly and predicate device are equivalent, the result of the performance testing is evidence that CT Cardiomegaly performs in an equivalent manner to the EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System.

7.2. Performance Assessment

A technical performance assessment was performed for CT Cardiomegaly to validate the accuracy for both linear-based CTR (i.e. Cardiothoracic Index) and area-based CTR (i.e., Heart to Chest Area Ratio) against the measurements provided by human readers using manual segmentation tools (i.e., reference standard).

Image /page/10/Picture/10 description: The image contains the logo for Innolitics SaMD Simplified. The logo consists of a blue hexagon-like shape on the left, followed by the word "Innolitics" in large, bold, blue font. Below "Innolitics" is the phrase "SaMD Simplified" in a smaller, lighter blue font. The overall design is clean and professional.

11

Image /page/11/Picture/0 description: The image contains the logo for "Body Check". The logo consists of a green circle with a check mark that is partially green and partially dark blue. To the right of the logo is the text "Body Check", with the word "Body" in green and the word "Check" in dark blue.

Reference Standard 7.2.1.

The reference standard for this assessment was established by three board-certified radiologists. Each radiologist provided a segmentation for the heart and the inner chest independently from the other radiologists. Measurement among the three radiologists was very high for all measured values.

7.2.2. Training and Testing Dataset

Data was sampled from a database curated by the University of Alabama at Birmingham of over 8,000 imaging studies from over 300 unique imaging sites. Data for training (1600 cases) and testing (275 cases) were sampled from this database based on exclusion criteria. Data was also selected to ensure no site was shared by training and testing cohorts.

The testing dataset included 275 unique patients cases from sites across 12 U.S. states. Subgroups and confounders present in the dataset included patient demographics (age, sex, race, ethnicity), confounding conditions, and imaging characteristics (protocol, slice thickness, scanner manufacturer, presence or absence of contrast, kVp). Images were representative of numerous scanner manufacturers (e.g., GE, Siemens, Philips, Canon Medical Systems, Toshiba, Siemens Healthineers, United Imaging Healthcare) and imaging protocols (i.e., abdominal CT, chest CT, PET/CT and high-resolution chest CT). The data consisted of 142 male and 133 female patients of different ethnicities aged 18-96 (median 62) years. Detailed subgroup analysis are reported in the labeling.

7.2.3. Primary Endpoints

Primary endpoints involved calculating the difference between the average measurement of the human readers and the subject device's measurement. The experimental unit was per patient. Clinical performance testing showed strong agreement with physician-derived measurements, with an average difference less than 0.01. Additional analysis including the Bland Altman plot and Limits of agreement were also conducted and reported in labeling. The 95% limits of agreement were [-0.033, 0.035] and [-0.028, 0.035] for Cardiothoracic Ratio and Heart to Chest Area Ratio, respectively.

| Measurement | Mean Absolute
Difference [95% CI] | Mean Difference
[95% CI] | Mean Difference
Target | Standard Deviation
of Differences | Result |
|------------------------------|--------------------------------------|-----------------------------|---------------------------|--------------------------------------|--------|
| Cardiothoracic
Ratio | 0.009 [0.007, 0.011] | 0.0012 [-0.0008,
0.0033] |