(268 days)
Yes
The summary explicitly mentions the use of "artificial intelligence," "deep learning," and an "AI detection algorithm" for tasks like view identification, segmentation, and automated measurements.
No.
The device quantifies and reports echocardiography data for diagnosis and analysis, but it does not provide therapy or treatment.
Yes
The device is intended for "quantifying and reporting echocardiography" and its functions include "echocardiography multiframe DICOM classification and automatic measurement" and "providing the report for analysis." These activities are indicative of a diagnostic purpose, as they involve interpreting medical images to provide information for a physician's diagnosis.
Yes
The device description explicitly states "Sonix Health will be offered as SW only, to be installed directly on customer PC hardware." and the functions described are purely software-based image processing and analysis.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Sonix Health's Function: Sonix Health processes and analyzes medical images (specifically ultrasound images) acquired from a medical imaging device. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for "quantifying and reporting echocardiography," which is the analysis of the heart's structure and function using ultrasound images. This is a form of medical imaging analysis, not an in vitro diagnostic test.
- Device Description: The device description focuses on processing DICOM images, performing measurements on those images, and generating reports based on the image analysis. This aligns with medical image processing software, not an IVD.
In summary, Sonix Health is a medical image processing software that aids in the analysis of echocardiography images. It does not perform tests on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations.
Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.
Product codes
QIH, LLZ
Device Description
Sonix Health comes with the following functions:
- Checking ultrasound multiframe DICOM
- Echocardiography multiframe DICOM classification and automatic measurement.
- Verification of the results and making adjustments manually.
- Providing the report for analysis
Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network.
Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning according to the view. The deep learning algorithms for the second step are categorized as B-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
- Sonix Health utilizes artificial intelligence to automate previous manual quantification tasks, resulting in increased efficiency for users.
- Semi-automated adult echocardiography 2D and Doppler measurements are generated using and artificial intelligence (AI) detection algorithm without user interaction.
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiovascular
Indicated Patient Age Range
Adult populations
Intended User / Care Setting
Licensed physician.
Inside of hospitals, clinics, and physician's offices.
Description of the training set, sample size, data source, and annotation protocol
The training data was collected from six centers. Among these, the demographic data from the representative institution showed 50.2% male participants, an average body mass index of 22.2, and 67.0% left ventricle ejection fraction.
Description of the test set, sample size, data source, and annotation protocol
The training data and validation data are distinct and independent. The ground truth annotation for the test was performed by two experienced sonographers with a Registered Diagnostic Cardiac Sonographer (RDCS) certification. The annotation was supervised by two experienced cardiologists and the consensus annotation was used as the final ground truth.
For performance testing, we used 476 B-mode clinical images, 243 M-mode clinical images, and 2,025 Doppler images, resulting in a total of 2,744 test images to assess these functions. Of these, 2,648 (96.5%) were from American participants. The data was respectively collected with 1,264 (47.7 %) from a U.S. hospital and 1,384 (52.3%) from a South Korea hospital. The gender distribution for the American participants was 65% male and 35% female. Data was acquired using equipment from four manufacturers.
The test was conducted blinded to private data, including patients' disease status. However, we measured LVEF based on the ground-truth of the validation datasets. The results showed that the left ventricle ejection fraction (LVEF) ranged from 14% to 76%, with a mean LVEF of 58% and a standard deviation of 11%. The normal LVEF (%) range for females is 54% to 74%, while for males is 52% to 72%.
Summary of Performance Studies
Sonix Health passed the test in two categories: an average accuracy of 98.22% for view recognition and a 93.98% average correlation coefficient when compared to manual measurements by participating experts.
No clinical testing conducted in support of substantial equivalence when compared to the predicate and reference devices.
Key Metrics
- Average accuracy for view recognition: 98.22%
- Average correlation coefficient when compared to manual measurements by participating experts: 93.98%
Predicate Device(s)
Reference Device(s)
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).
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.
Ontact Health Co., Ltd. Hyuk-Jae Chang CEO 5f, 50-5, Ewhayeodae-gil, Seodaemun-gu Seoul, KS013/03764 Korea. South
Re: K230209
October 20, 2023
Trade/Device Name: Sonix Health Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: October 19, 2023 Received: September 21, 2023
Dear Hyuk-Jae Chang:
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 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).
Sincerelv.
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230209
Device Name Sonix Health
Indications for Use (Describe)
Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations.
Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.
| 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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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date
October 19, 2023
Submitter's Information & Contact Person 2.
- Submitter: ONTACT HEALTH Co., Ltd.
- Address: 5F Erom Tower, 50-5, Ewhayeodae-gil, Seodaemun-gu, Seoul, 03764, Republic of Korea
- Contact Person: Hyuk-Jae Chang / CEO
- Telephone No.: +82-2- 362-9610
- Email Address: ontact(01@ontacthealth.com
Trade Name, Common Name, Classification 3.
- Workstation Software for cardiac ultrasound image review, analysis, and reporting - Common name:
- Trade name: Sonix Health
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Automated Radiological Image Processing Software | 21 CFR 892.2050 | QIH, LLZ |
As stated in 21 CFR parts 892.2050 of the device has been classified as Class II.
4. Identification of Predicate Device(s)
The identified predicate devices within this submission are shown as follow:
Predicate Device
- 510(k) Number: K213544 .
- Trade/Device name: TOMTC-ARENA
- Manufacturer: TOMTEC Imaging Systems GmbH .
Reference Device
- . 510(k) Number: K220975
- . Trade/Device name: V8 Diagnostic Ultrasound System,
- Manufacturer: Samsung Medison Co., Ltd. .
4
Description of the Device 5.
Sonix Health comes with the following functions:
- Checking ultrasound multiframe DICOM
- Echocardiography multiframe DICOM classification and automatic measurement.
- Verification of the results and making adjustments manually.
- Providing the report for analysis
Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network.
Image /page/4/Figure/7 description: The image shows a diagram of a local area network with a personal computer connected to a NAS. The personal computer has a Sonix Health application running on it. The Sonix Health application has a Windows application and an AI Engine. The Windows application and AI Engine are connected to each other.
Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning according to the view. The deep learning algorithms for the second step are categorized as B-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.
6. Indications for Use
Sonix Health is intended for quantifying and reporting echocardiography for use by or on the order of a licensed physician. Sonix Health accepts DICOM-compliant medical images acquired from ultrasound imaging devices. Sonix Health is indicated for use in adult populations.
Ultrasound images are acquired via the B (2D), M, Pulsed-wave Doppler, and Continuous-wave Doppler modes.
5
7. Determination of Substantial Equivalence
The identified predicate devices within this submission is shown in the following table:
| Description | Decision | Subject Device (K230209) | Predicate Device (K213544) | Reference Device (K220975) |
|---|---|---|---|---|
| Trade/Device name | Sonix Health | TOMTEC-ARENA | V8 Diagnostic Ultrasound System | |
| Product Code | QIH (Subsequent Product Code: LLZ) | QIH (Subsequent Product Code: LLZ) | IYN, IYO, ITX | |
| Regulatory Class | SE | 2 | 2 | 2 |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1550, 892.1560, 892.1570 | |
| Intended use | SE | Sonix Health is intended for quantifying | ||
| and reporting echocardiography for use by | ||||
| or on the order of a licensed physician. | ||||
| Sonix Health accepts DICOM-compliant | ||||
| medical images acquired from ultrasound | ||||
| imaging devices. Sonix Health is indicated | ||||
| for use in adult populations. |
Ultrasound images are acquired via the B
(2D), M, Pulsed-wave Doppler, and
Continuous-wave Doppler modes. | TOMTEC-ARENA software is a
clinical software package designed for
review, quantification and reporting of
structures and function based on multi-
dimensional digital medical data
acquired with different modalities.
TOMTEC ARENA is not intended to
be used for reading of mammography
images. | The V8 / V7 diagnostic ultrasound system and
probes are designed to obtain ultrasound images
and analyze body fluids.
The clinical applications include: Fetal/Obstetrics,
Abdominal, Gynecology, Intra-operative, Pediatric,
Small Organ, Neonatal Cephalic, Adult Cephalic,
Trans-rectal, Trans-vaginal, Muscular-Skeletal
(Conventional, Superficial), Urology, Cardiac
Adult, Cardiac Pediatric, Thoracic, Trans-
esophageal (Cardiac) and Peripheral vessel.
It is intended for use by, or by the order of, and |
| Indications for use | SE | | Indications for use of TOMTEC-
ARENA TTA2 software are
quantification and reporting of
cardiovascular, fetal, abdominal
structures and function of patients with
suspected disease to support the
physician in the diagnosis | under the supervision of, an appropriately trained
healthcare professional who is qualified for direct
use of medical devices. It can be used in hospitals,
private practices, clinics and similar care
environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler
mode, Power Doppler (PD) mode, M mode, Pulsed
Wave (PW) Doppler mode, Continuous Wave
(CW) Doppler mode, Tissue Doppler Imaging
(TDI) mode, Tissue Doppler Wave (TDW) mode,
ElastoScan Mode, Combined modes, Multi-Image
mode (Dual, Quad), 3D/4D mode. |
| Where used
(hospital, home,
ambulance, etc.) | SE | Inside of hospitals, clinics, and physician's
offices. | Inside and outside of Hospitals,
Clinics, and Physician's offices. | Inside of hospitals, clinics, and physician's offices. |
| Application
description | SE | Sonix Health utilizes artificial intelligence
to automate previous manual quantification
tasks, resulting in increased efficiency for
users. Our system performs view | IMAGE-COM is a basic module for
reviewing and measuring digital
medical data. It supports routine
workflows for loading, analyzing and | The V8 / V7 are a general purpose, mobile,
software controlled, diagnostic ultrasound system.
Their function is to acquire ultrasound data and to
display the data as 2D mode,Color Doppler mode, |
| Description | Decision | Subject Device (K230209) | Predicate Device (K213544) | Reference Device (K220975) |
| | | classification and measurements according
to the US ASE guidelines, and the users
can review and modify the results if
necessary. | saving medical studies, e.g. for the
purpose of creating reports. IMAGE-
COM is where basic measurements can
be performed and the entry point for
advanced analysis modules. Study
related routine measurements can be
imported, displayed, edited and
exported to accompanying reporting
systems. | Power Doppler (PD) mode, M mode, Pulsed Wave
(PW) Doppler mode, Continuous Wave (CW)
Doppler mode, Tissue Doppler Imaging (TDI)
mode, Tissue Doppler Wave (TDW) mode,
ElastoScan Mode, Combined modes, Multi-Image
mode(Dual, Quad), 3D/4D mode. The V8 / V7 also
give the operator the ability to measure anatomical
structures and offer analysis packages that provide
information that is used to make a K223387
Traditional 510(k) diagnosis by competent health
care professionals. The V8 / V7 have a real time
acoustic output display with two basic indices, a
mechanical index and a thermal index, which are
both automatically displayed. |
| Semi-automated
view classification | SE | PLAX LV, A4C, A4C Zoomed LV, A2C,
A2C zoomed LV, M-mode LA/Ao, M-
mode LV, CW Doppler MS, CW Doppler
MR, PW Doppler MV, CW Doppler AV,
CW Doppler AR, CW Doppler TR, CW
Doppler PV, CW Doppler PR, PW Doppler
RVOT, PW Doppler LVOT, DTI MV
annulus | PLAX LV, A4C, A4C Zoomed LV, A2C, A2C
zoomed LV, M-mode LA/Ao, M-mode LV, CW
Doppler MS, CW Doppler MR, PW Doppler MV,
CW Doppler AV, CW Doppler AR, CW Doppler
TR, CW Doppler PV, CW Doppler PR, PW
Doppler RVOT, PW Doppler LVOT, DTI MV
annulus | PLAX LV, A4C, A4C Zoomed LV, A2C, A2C
zoomed LV, M-mode LA/Ao, M-mode LV, CW
Doppler MS, CW Doppler MR, PW Doppler MV,
CW Doppler AV, CW Doppler AR, CW Doppler
TR, CW Doppler PV, CW Doppler PR, PW
Doppler RVOT, PW Doppler LVOT, DTI MV
annulus |
| Semi-automated
measurements | SE | IVSd (2D), IVSs (2D), LVIDd (2D),
LVIDs (2D), LVPWd (2D), LVPWs (2D),
LA (2D), Ao (2D), LVESV / LVEDV
(4CH), LAV (4CH), LVESV / LVEDV
(4CH), LVESV / LVEDV (2CH), LAV
(2CH), LVESV / LVEDV (2CH), LA (m-
mode), Aorta (m-mode), IVSd (m-mode),
LVIDd (m-mode), LVPWd (m-mode),
IVSs (m-mode), LVIIDs (m-mode),
LVPWs (m-mode), MV Peak E Vel, MV
Peak A Vel, MV Decel Time, e' (med), a'
(med), s' (med), LVOT Vmax, LVOT VTI,
RVOT Vmax, RVOT VTI, PV AccT, TR
Vmax, TR VTI, AR Vmax / PR Vmax, AR
PHT / PR PHT, MV Vmax, MV VTI, MV,
PHT, MR Vmax, MR VTI, AV Vmax / PV
Vmax, AV VTI / PV VTI, RVOT (2D) | B-Mode
- Ao Asc diam, Ao Ann diam, Ao STJ
diam, Ao SV diam, IVSd, LA diam
systole, LVIDd, LVIDs, LVOT diam,
LVPWd, RVDd base (RVD1), RVDd
mid (RVD2), RVLd, RVOT diam lax,
RVOT diam prox, TV Ann diam ant-
post, IVSd-LVIDd-LVPWd (Same
line)
DOPPLER Mode
- MV A Vel, MV E Vel, MV E/A
Slope, (MV A Vel, MV E Vel, MV
Time), MV Dec. Slope, (MV Dec
Time, MV E Vel), LVOT VTI, AV
VTI, PV VTI, TR Vmax, LV E'(l), LV
A'(l), LV E'(s), LV A'(s), RV A'(l),
RV E'(l), RV S'(l) | (PLAX LV) - Interventricular septum diameter at the
diastole and systole phase, LV internal diameter at
the diastole and systole phase, LV posterior wall
diameter at the diastole and systole phase, Aorta
diameter and LA diameter, (A4C) - LA Volume, LV
Volume, (A4C Zoomed LV) - LV Volume, (A2C) -
LA Volume, LV Volume, (A2C zoomed LV) - LV
Volume, (M-mode LA/Ao) - LA diameter and Aorta
diameter, (M-mode / LV) - Interventricular septum
diameter at the diastole and systole phase, LV
internal diameter at the diastole and systole phase,
LV posterior wall diameter at the diastole and systole
phase, (CW Doppler MS) - Vmax, VTI, PHT, (CW
Doppler MR) - Vmax, VTI, (PW Doppler MV) - E.
A, DT, (CW Doppler AV) - Vmax, VTI, (CW
Doppler AR) - Vmax, PHT, (CW Doppler TR) -
Vmax, VTI, (CW Doppler PV) - Vmax, VTI, (CW
Doppler PR) - Vmax, EDV, (PW Doppler RVOT) –
Vmax, VTI, (PW Doppler LVOT) - Vmax, VTI,
(DTI MV annulus) - S', E', A' |
| Description | Decision | Subject Device (K230209) | Predicate Device (K213544) | Reference Device (K220975) |
| Semi-automation
technology | SE | After the automated analysis is complete,
users can review and modify the results as
needed. The product is intended for use by,
or on the order of a licensed physician. | Semi-automated adult
echocardiography 2D and Doppler
measurements are generated using and
artificial intelligence (AI) detection
algorithm without user interaction.
After measurement is generated, the
user can edit (manually adjust the
caliper positions), accept, or reject the
measurements. The automation of
measurements is constrained to the
specific imaging mode (2D, Doppler)
as recommended by ASE guidelines. | After the analysis is complete, users can review and
modify the results as needed. The product is for use
by, or on the order of a licensed physician. |
6
7
- It is necessary for the end user to verify, confirm, and modify the analysis results when using Subject Device.
8
8. Non-Clinical Test Summary
Performance Standards
Digital Imaging and Communications in Medicine (DICOM) Set (Ps3.1 - .20) IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices. IEC 62366-1 Edition 1.1 2020-06, Medical devices-Part 1 Application of usability engineering to medical devices.
Sonix Health is classified as a Moderate Level of Concern. The software verification and validation were conducted in compliance with IEC 62304 "Medical device software life cycle process" and the internal design control process to ensure safety and effectiveness. Throughout the verification and validation process, traceability was maintained, encompassing risk management (including Cyber Security and Usability).
Sonix Health was designed to assist clinicians in adult echocardiography examinations. The training data was collected from six centers. Among these, the demographic data from the representative institution showed 50.2% male participants, an average body mass index of 22.2, and 67.0% left ventricle ejection fraction.
The training data and validation data are distinct and independent. The ground truth annotation for the test was performed by two experienced sonographers with a Registered Diagnostic Cardiac Sonographer (RDCS) certification. The annotation was supervised by two experienced cardiologists and the consensus annotation was used as the final ground truth.
For performance testing, we used 476 B-mode clinical images, 243 M-mode clinical images, and 2,025 Doppler images, resulting in a total of 2,744 test images to assess these functions. Of these, 2,648 (96.5%) were from American participants. The data was respectively collected with 1,264 (47.7 %) from a U.S. hospital and 1,384 (52.3%) from a South Korea hospital. The gender distribution for the American participants was 65% male and 35% female. Data was acquired using equipment from four manufacturers.
The test was conducted blinded to private data, including patients' disease status. However, we measured LVEF based on the ground-truth of the validation datasets. The results showed that the left ventricle ejection fraction (LVEF) ranged from 14% to 76%, with a mean LVEF of 58% and a standard deviation of 11%. The normal LVEF (%) range for females is 54% to 74%, while for males it is 52% to 72%.
Sonix Health passed the test in two categories: an average accuracy of 98.22% for view recognition and a 93.98% average correlation coefficient when compared to manual measurements by participating experts.
Through verification and validation activities, Sonix Health is confirmed to meet all the design and performance requirements, ensuring safety and effectiveness without raising adverse issues. In conclusion, it demonstrates substantial equivalence.
Clinical Test Summary
No clinical testing conducted in support of substantial equivalence when compared to the predicate and reference devices.
9. Conclusion
In conclusion, all verification and validation activities demonstrated that the design specifications and technological characteristics of Sonix Health meet the applicable requirements and standards for the safety and effectiveness of the device for its intended use. As a result. Sonix Health is substantially equivalent to the currently marketed predicate device.