E506M001.
User Manual for Agile 3+ V1
E506M001.1 – Agile 3+ v1.0 – January 2020
EN
Table of contents
1. Purpose of the user manual .............................................................................................................................. 4
2. Indications ......................................................................................................................................................... 4
Intended Use............................................................................................................................................................... 4
Indication for use ......................................................................................................................................................... 4
Precautions for use ..................................................................................................................................................... 4
Target Population ........................................................................................................................................................ 5
Intended User ............................................................................................................................................................. 5
Intended Environment ................................................................................................................................................. 5
3. Classification ..................................................................................................................................................... 5
4. Performance characteristics .............................................................................................................................. 5
Claimed performances characteristics ........................................................................................................................ 5
Specified clinical benefits ............................................................................................................................................ 5
Clinical results summary ............................................................................................................................................. 5
5. Technical recommendations for FibroScan® procedure.................................................................................... 6
6. User registration for Agile 3+ access ................................................................................................................. 7
Downloading and sign in ............................................................................................................................................. 7
Registration ................................................................................................................................................................. 7
7. Agile 3+ use cases ............................................................................................................................................ 8
Using myFibroScan accessory.................................................................................................................................... 8
Home page .............................................................................................................................................................. 8
Inputs screen ........................................................................................................................................................... 8
Results screen ......................................................................................................................................................... 9
Report creation ........................................................................................................................................................ 9
Using Echosens API ................................................................................................................................................. 10
Authentication via API ........................................................................................................................................... 10
Score computation via API .................................................................................................................................... 11
8. Symbols on the device .................................................................................................................................... 12
Contact us .................................................................................................................................................................... 12
About ............................................................................................................................................................................ 12
2
E506M001.1
3
E506M001.1
1. Purpose of the user manual
The present User Manual has no contractual value whatsoever and under no circumstances may Echosens be held
responsible on the basis of the information contained in the present manual.
The present User Manual details the information required for the use of Agile 3+ computation.
Echosens publishes this manual "as is'", without guarantees of any nature, whether explicit or implicit, including, but
not limited to, implicit guarantees concerning merchantability or fitness for a particular use, for the purpose of providing
simple and accurate information. Consequently, Echosens cannot accept any responsibility for any incorrect
interpretation of the manual. Though all efforts have been made to offer a manual that is as accurate as possible,
the manual may nevertheless contain some technical inaccuracies and/or typographical errors.
Echosens cannot, under any circumstances, be held responsible for any loss of profit, loss of business, data
loss, business interruption, or for any indirect, specific, accidental or consecutive damages of any type.
Any information or modification requests pertaining to this manual should be sent to: Echosens, 6 rue Ferrus, 75014
PARIS, France or support-it@echosens.com.
Agile™, EchosensTM, TM, FibroScan®, ® among others, are trademarks and/or service marks of
Echosens Group. Echosens and FibroScan are registered in the U.S. and/or other countries. © 2020 Echosens. All
rights reserved.
2. Indications
Intended Use
Agile 3+ is an algorithm using liver stiffness measurement, clinical and laboratory parameters intended to compute a
probability of advanced fibrosis in patients with suspicion of Non Alcoholic Fatty Liver Disease to help the physician
identify those patients.
Indication for use
Agile 3+ is indicated in patients with suspicion of Non Alcoholic Fatty Liver Disease to identify advanced fibrosis
defined as a fibrosis stage superior or equal to F3 according NASH CRN scoring system. It may be used as an aid to
diagnosis and monitoring of patient with Non Alcoholic Fatty Liver Disease.
Precautions for use
The following circumstances may affect the results obtained and therefore may affect the interpretation of Agile 3+
result:
x Pregnancy
x Patients under 18 years of age
x Other chronic or acute liver disease than NAFLD
x Liver transplant patients
x Cardiac failure and/or significant vascular disease
x Confirmed diagnosis of active malignancy or other terminal disease
x Use of treatment inducing liver injury
To get a reliable result:
x LSM should come from an examination performed with a FibroScan device
x LSM and blood collection for AST, ALT and PLT measurements should be performed within 31 days.
4
E506M001.1
Target Population
Agile 3+ is indicated for adult patients with suspicion of NAFLD.
Intended User
Intended users are clinicians dealing with patients suspected of liver diseases.
Intended Environment
Agile 3+ is accessible through devices connected to the internet using dedicated services. Users shall authenticate
and confirm his/her status and abilities to use Agile 3+.
3. Classification
Agile 3+ is Medical Device (class I) according to directive 93/42/EEC.
4. Performance characteristics
Claimed performances characteristics
Agile 3+ compute a value between 0 and 1, if all input parameters have been entered with the appropriate units.
Specified clinical benefits
Non-invasive aid to diagnosis and monitoring of advanced fibrosis in patients with Non Alcoholic Fatty Liver Disease.
Clinical results summary
Data sets F3 Score / Agile 3+ AUC LSM AUC [95%CI] FIB-4 AUC [95%CI]
(N, Prevalence of F≥3 = [95%CI]
%)
Internal validation 0.90 [0.88-0.92] 0.85 [0.82-0.88] 0.84 [0.81-0.86]
(700, Prevalence =
54%)
External validation #1 0.86 [0.84-0.89] 0.83 [0.80-0.80] 0.78 [0.74-0.82]
(585, Prevalence =
37%)
External validation #2 0.87 0.84 0.78
(1042, Prevalence =
38%)
Table 1: Agile 3+Clinical Performances: AUCs
5
E506M001.1
Figure 1 : Percentage of patients in rule out (<85% Se threshold), indeterminate and rule in zones (≥90% Sp
threshold) for the diagnosis of advanced fibrosis with FIB-4, LSM and F3 score
5. Technical recommendations for FibroScan® procedure
The measurement of liver stiffness (E) shall be done by an operator trained and certified by Echosens or its local
representative according to the recommendations of Echosens with a probe fitted to the morphology of the patients as
described in the FibroScan® user guide.
The FibroScan® examination results should fulfill reliability criteria defined in the publication entitled “Determination of
reliability criteria for liver stiffness evaluation by transient elastography” by Boursier J, Zarski JP, de Ledinghen V,
Rousselet MC, Sturm N, Lebail B, Fouchard-Hubert I, Gallois Y, Oberti F, Bertrais S, Cales P and the Multicentric Group
from ANRS/HC/EP23 FIBROSTAR St published in Hepatology in 2013 volume 57(3) page 1182-1191.
6
E506M001.1
6. User registration for Agile 3+ access
Downloading and sign in
myFibroScan application can be used on iOS and Android platforms. It
is available on both Apple store and Google play store. Once it has
been downloaded, anyone can launch the application but he/she has to
be registered to access Echosens services.
The screen aside appears. The application is available both in French
and English. However, by default, this page language is based on the
phone language.
If the user is already registered, he can connect himself/herself by
entering his/her login and password and clicking on “Sign In” button. If
not, the user should create an account by clicking on “Sign Up” button.
Once signed-in, unless he/she specifically logs out from the application,
the user will be automatically logged-in and will not have to enter his
credentials again.
Figure 2: Sign In screen
Registration
To access Agile 3+, any user has to create an account on Echosens Cloud services by clicking on “Sign Up”. He/she
then accesses to the following screens:
Figure 3: Account creation on Echosens Cloud Services
Any field with a star is required. Language, specialty, type of institution and country are to be chosen in a picklist.
Password shall fit the following rules to be acceptable:
x composed of alphanumeric characters
x contain at least 8 characters
7
E506M001.1
x contain at least one digit
x contain at least one uppercase
x contain at least one lowercase
All conditions have to be acknowledged by checking the checkbox except the last one before the user can confirm
his/her registration.
General Conditions for Use are available on Echosens website and are accessible by clicking on the link.
Then, the user can sign up. If all mandatory fields are correctly filled, a message will confirm his/her account creation
and display the next instructions. Otherwise, an error message will appear to guide the user.
An automatic message will be sent to the user mailbox to confirm his/her email address. The user has to click on the
confirmation link before being able to login into the application (account activation).
7. Agile 3+ use cases
Using myFibroScan accessory
Home page
Once logged-in, the user access to the home page screen (figure 3).
x Agile 3+is available under the “Score” menu
Inputs screen
By clicking on the “Agile 3+ ” block, the user accesses
to the Agile 3+ input screen (figure 4).
The user can fill E (Stiffness) values manually or by
scanning a QR code printed on a FibroScan
examination report.
The other input parameters shall be entered manually.
Invalid values will be notified to the user. He will not be
able to submit its computation with out of range values
of bad/missing units.
The user has to confirm that:
x No more than 1 months separates FibroScan
examination and blood sampling
x the physician is aware of precautions for use
related to Agile 3+ score computation
The user can access to:
x This user guide by clicking on “Learn more”
x Agile 3+ formula by clicking on publication
Then, the user can submit his/her computation or go
8
E506M001.1
back to the home page by clicking on the
pictogram.
Results screen
After submission, the user accesses to the results screen. He/She can
consult the input parameters he/she submitted and the associated result.
If he/she wants to update one of these values, the user can come back to
the inputs screen by clicking on the pictogram.
Again, the user can access to:
x this user guide by clicking on “Learn more”
x Agile 3+ formula by clicking on publication
From here, he can generate the corresponding report by clicking on
“Create a report” or go back to the home page by clicking on the
pictogram.
Report creation
To generate a report, the user has to enter personal
patient data. Several options are possible:
x If E value has been scanned from a
FibroScan examination report, then the
corresponding patient information are
automatically filled and the user only needs
to confirm the statement: the patient is aware
of data processing before being able to
generate the report
x If not, the user can re-use data previously
entered by selecting a patient from the
patient list and confirm the statement
Or he/she can create a new patient file. It will be
locally stored on the phone and will be visible in the
patient list for future use. Fields with a red star are
mandatory.
Once done, the user can submit the data or go back
to the home page by clicking on the pictogram.
9
E506M001.1
Once submitted, the user has to fill or select FibroScan examination date
and blood collection date (figure 7).
Even if the time elapsed between these two dates is longer than the
threshold mentioned in the Agile 3+ input specifications, the report will be
generated. However, the Agile 3+ result will not be displayed as it does
not meet the specific indications agreed by the user to use the Agile 3+
computation module.
Once done, the user can click on Submit button. The report is generated,
downloaded on the phone and can be open by any PDF reader available
on the device. He/She can go back to the home page by clicking on the
pictogram.
Figure 4: Examinations dates
Using Echosens API
Users can performs direct API call without using myFibroScan interface to perform Agile 3+ computations.
x They won’t be allowed to generate report
x The user shall have been signed-up to ECS using myFibroScan interface beforehand.
Authentication via API
To access Agile 3+ features, users shall authenticated via API request (token authentication)
this is a POST request with the following attributes.
url
https://myfibroscan-eu-west-1.echosens.cloud/authorize
header
{
"content-type": "application/json; charset=utf-8",
"Accept": "application/json"
}
json
{
"userName": your_username,
"pwd": your_password
}
your access token is in the "Authorization" attribute of a successful request. You should add it to the header of all the
10
E506M001.1
following requests, in the “Authorization” attribute, prefixed by “Bearer “ as explained below.
Score computation via API
Once the authentication token is obtained, the user can perform computation request as follow:
This is a POST request with the following attributes.
url
https://myfibroscan-eu-west-1.echosens.cloud/score-f3/apis/compute
header
{
"content-type": "application/json; charset=utf-8",
"Accept": "application/json"
"Authorization": "Bearer your_authentication_token"
}
json
{
"lsm": {
"value": 9.0,
"unit": "kPa"
},
"ast": {
"value": 20,
"unit": "U/L"
},
"alt": {
"value": 20,
"unit": "U/L"
},
"plt": {
"value": 150,
"unit": "10*9/L"
},
"age": {
"value": 41,
"unit": "a"
},
"diabete": false,
"gender": "Female",
"bsDate": "YYYY-mm-dd",
"fsDate": "YYYY-mm-dd",
"precAndCIOk": true,
"disclaimerOK": true,
"country": "France"
}
A successful request will return a json structure as output
11
E506M001.1
{
"results": {
"score": the_numerix_result,
"image": the_enpred_result_image
},
"inputs": the_inputs_used_for_computation
}
8. Symbols on the device
Agile 3+ device
CE marking affixed by Echosens in May 2021
Medical Device
Manufacturer
Contact us
The user can contact Echosens by clicking on the Contact us pictogram. It will redirect him/her towards the support
platform in which he/she will be able to fill a request form.
About
By clicking on the About pictogram, the user can consult general information regarding Echosens, myFibroScan,
trademarks and patents.
E506M001.1 – Agile 3+ V1.0 – January 2021
12
E506M001.1
Echosens
6 rue Ferrus
75014 Paris
FRANCE
+33 1 44 82 78 50
www.echosens.com
support-it@echosens.com
13
