Fetoly-AI Ultrasound Assistant

Intended purpose:

FETOLY is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically:

- detect brain and heart views and quality criteria within the views;

- detect images suitable for measuring biometric parameters of the fetal heart and brain and provide quantitative measurements of these parameters.

The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.

FETOLY is indicated for use during routine fetal heart and brain examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).

Our software helps healthcare professionals with four tasks:

- Completeness measurement: Displays in real-time which fetal brain/heart views and quality criteria are verified by the software during the examination. The verified brain/heart views and quality criteria are accessible in real-time.

- Automatic measurement: Displays in real-time which fetal brain and heart measurements are seen and done by the software during the examination and if the measurements are in- or out-of-range. The verified heart and brain measurements are accessible by clinicians in real-time.

- Examination illustration: the software selects an image subset that illustrates

- the verified views and quality criteria. These images can be reviewed by clinicians to verify the views and criteria’s presence. Optionally, clinicians can display detected quality criteria localization on selected images.

- each measurement. For each measurement, the software displays an image with the measurement drawn and the measured value. The normal range for this measurement is also reminded to the user.

- Examination report: The software allows the user to export an examination report which contains:

- A summary of measurements and completeness;

- Illustrations (images) with measurement drawn and value.

Operating instructions:

Please install the software on a compatible tablet (see below) and follow sections 12 and 13 of the eIFU for operating instructions.

FETOLY can be used only with a license provided by Diagnoly. This license is linked to the contract signed with the company.

The license needs internet connection to be validated. An internet connection will be asked at least each 30 days for update and license verification purpose.

Notice that FETOLY shall be configured before use. This configuration is related to ultrasound system connection, video stream input and export.

Related hardware:

FETOLY shall be installed on the tablet. Minimum requirements are found in section 10 of the e-IFU as follows:

- CPU architecture ARMv8

- A Snapdragon 8 processor

- At least 8GB of RAM capacity

- At least 1GB of storage capacity

- Android in version 13 or higher

Please reach Diagnoly for any question on tablet choice.

FETOLY is compatible with the following video capture devices:

FR

https://tinyurl.com/zr5p86yy

US

https://tinyurl.com/nn8943re

FETOLY is compatible with ultrasound systems from Samsung, GE and Canon.

Set-up and connection security:

Please refer to section 12 of the e-IFU for cybersecurity instructions.

Warning and precautions:

Please see section 10 of the e-IFU for warning and precautions. There is no major warning or contraindication linked to FETOLY.

e-IFU: https://diagnoly.com/fetoly-ifu.html

The Instructions For Use (IFU) can be ordered in paper format by contacting support@diagnoly.com.

FETOLY is manufactured by:

DIAGNOLY SAS (FR-MF-000037822)

60 avenue Rockefeller, 69008 LYON, France

Tel.: +33(0)4.78.76.85.75

Product complaints: support@diagnoly.com

Please report any serious incident to Diagnoly through product complaints e-mail address and to the Competent Authority of your country.

UDI-DI: 3770033463031

Notified body number: 0197

Certificates number:

CE MDR: HZ 2527981-1

EN ISO 13485:2016: SX 2527981-1