Instructions for Use

Introduction

These instructions for use will guide you through the use of the SkinScreener API medical device. The SkinScreener API is implemented into a third party solution via a SDK and allows you to perform a skin lesion risk assessment for visual signs of premalignancy and malignancy quickly and easily. Our artificial intelligence has been trained using appropriate images and compares the lesion you have captured with an existing dataset of images to perform a risk assessment of your lesion. It does not provide a medical diagnosis!

The third party application is available on the App Store® and Google Play Story. These Instructions for Use are applicable for SkinScreener API in the product version v1. The instructions for use can be accessed from the SKD’s “Your Account” screen. Please ensure that you always update the app to the newest compatible version.

Instructions for use are available in electronic form. Upon user request, a paper form of instructions for use can be provided, which will be sent to the user within 3 working days. Please contact our support team at support@medaia.atlassian.net to order a printed version of the instructions for use free of charge.

If you have any further questions about using the SkinScreener API, please contact us at support@medaia.atlassian.net.

The SkinScreener API via a third party application is not intended to replace conventional methods of screening and assessing skin cancer risk, does not provide a diagnosis, and does not replace a visit to a medical professional.

Information for the end user

Meta Information

Version: 1.0
Date of issue: December 2024
Replaces version/revision: –
Product: SkinScreener API
Product version: 1.0

Please read the instructions for use carefully, especially the “Warnings” section.

The application allows you to perform a skin lesion risk assessment for visual signs of premalignancy and malignancy quickly and easily. The artificial intelligence has been trained by appropriate images and compares your captured lesion with an existing dataset of images to perform a risk assessment of your lesion.

The SkinScreener application is not intended to replace conventional methods of screening and assessing skin cancer risk, is not giving a diagnosis, and does not replace a medical professional’s visit.

If you have any further questions about using the application, please contact us at support@medaia.atlassian.net

1 Intended Use

SkinScreener API is an interface intended to provide a risk assessment of skin lesion images. The images of skin lesions are uploaded to our restful image endpoint, where the machine learning model processes the images to detect visual morphological elements of the most common malignant lesions (melanoma, squamous cell carcinoma, basalioma, Mb. Bowen) or precancerous lesions. Upon successful analysis, a JSON response with a risk assessment class is returned (LOW-RISK, MEDIUM-RISK or HIGH-RISK).

Based on the risk assessment, the user will receive a recommendation to see a dermatologist for further examination to obtain an accurate medical diagnosis. Users with medium or high risk assessments are sent to the dermatologist earlier for a lesion check-up to avoid further progress of the scanned suspicious lesion. The risk assessment can be further used for analytical or diagnostic purposes. Additional endpoints are provided for query, retrieving and deleting previously uploaded images.

SkinScreener API is intended to be used by adult users with Fitzpatrick skin type I (ivory) to IV (light brown). SkinScreener API interface may not be used on children. SkinScreener API cannot replace a dermatological examination, it is not giving a diagnosis and cannot be a substitute for visiting a healthcare professional.

Indication: To assess a lesion on human skin for possible visual signs of premalignancy or malignancy, using a three-level classification (LOW-RISK, MEDIUM-RISK or HIGH-RISK) solely through the use of artificial intelligence.

2 Intended User Group

• The intended user is over 18 years old and does not need any previous knowledge or training. Basic knowledge of using an Android or iOS mobile device is an advantage.
• The intended user has skin type I (ivory) to IV (light brown) (classification according to Fitzpatrick).
• Special language skills are not required as the application is available in the language of the target country/target market.
• A skin lesion scan on the skin can basically be performed on all body parts, except for the excluded body parts described in the Warnings/Exclusions chapter.
• Gender, age (18 years or older) or physical characteristics such as weight or height have no influence on the analysis.

3 Indications

• User is over 18 years old
• The user is capable to process and understand simple visual instructions/information.
• The user has Fitzpatrick skin type I to IV
• The user has a skin lesion on the skin (except lesions described in contraindications Nr. 3 – 11).

4 Contraindications and Limited Use

1. User is under 18 years old
2. The user has Fitzpatrick skin type V or VI.
3. The skin is sunburnt.
4. The lesion has been previously traumatized (excised/biopsied).
5. The skin surrounding the lesion is not intact (open sores, ulcers, bleeding).
6. The lesion is located on, or next to the anatomical structures (i.e. ear, eye, hair, mouth, nipples, genitals, fingers, toes, umbilicus).
7. The lesion is very close to visible scars or tattoo, or areas partly or fully covered with opaque or glittering substances like makeup, skin cream or sun cream.
8. The lesion is surrounded or covered hair.
9. The lesion is on mucosal surfaces like on lips, in the mouth or penis/vagina.
10. The lesion is not on human skin.
11. The lesion is in a skinfold.
12. Scanning lesions close to the eyes may cause temporary flash blindness caused by the camera light and should therefore be considered.
13. Individuals must not scan or be scanned when performing actions where this could cause harm (e.g. driving a car).
14. The SkinScreener API should not be used by people who may have difficulty recognizing a lesion to be assessed due to visual impairment, who have difficulty understanding the text or medical matters due to a lack of mental capacity, or who lack the technical understanding to operate a mobile device.
15. The SkinScreener API does not replace a regular consultation with a dermatologist.

5 Interpretation of the Results

Skinscreener provides a risk assessment in 3 easy to understand categories, the categories, and their specific meaning are listed below.

LOW RISK (green)

What does this mean?

Our clinically proven algorithm did not detect any conspicuous skin lesion in the examined region. The assessment was not made by a doctor and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and is not a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that due to various circumstances the risk assessment of the skin lesion is not correct. SkinScreener can make a significant contribution to supporting preventive care, but it cannot replace a regular check-up by your doctor, it can only supplement it in a meaningful way.

‍

What to do next?

Check this lesion and your entire skin from time to time; it is important that you see your dermatologist regularly for a medical check-up. Ask your dermatologist at what intervals you should come for a check-up. If you are not sure about this risk assessment or if the skin lesion changes, contact your dermatologist immediately.

MEDIUM RISK(yellow)

What does this mean?

Our clinically proven algorithm has assessed this skin lesion as conspicuous. Irregular patterns, different colouring, asymmetry, diffuse borders, increased diameter and increased keratinisation can be features of conspicuous skin lesions. The assessment was not made by a doctor and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and is not a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that due to various circumstances the risk assessment of the skin lesion is not correct. SkinScreener can make a significant contribution to supporting preventive care, but it cannot replace a regular check-up by your doctor, it can only supplement it in a meaningful way.

‍

What to do next?

The skin lesion must be examined more closely by a dermatologist. Your dermatologist has to determine the check-up periods as well as the skin areas concerned. Check this lesion and your entire skin from time to time.

HIGH RISK (red)

What does this mean?

Our clinically proven algorithm has assessed this skin lesion as very conspicuous and has identified possible different visual signs of skin cancer. For example, irregular patterns, different colouring, asymmetry, diffuse borders, increased diameter and keratinisation may indicate malignant skin lesions. The assessment was not made by a doctor and does not replace a medical examination. It is a risk assessment based solely on artificial intelligence and is not a diagnosis. Our artificial intelligence is constantly being improved. Nevertheless, there is a possibility that due to various circumstances the risk assessment of the skin change is not correct. SkinScreener can make a significant contribution to supporting preventive care, but it cannot replace a regular check-up by your doctor, it can only supplement it in a meaningful way.

‍

What to do next?

The skin lesion must be examined immediately by a dermatologist. He or she must also determine the further treatment, the check-up periods and the skin areas concerned. Check this lesion and your entire skin from time to time.

No Risk Assessment Possible

What does this mean?

Lesions next to anatomical structures are sometimes hard to detect. Also if an image is blurred, or if no lesion can be detected, no assessment is possible. In order to guarantee the quality and validity of our assessments, we have excluded some anatomical regions or blurred images for risk assessment.

‍

What to do next?

Ask your dermatologist for an assessment of this lesion.

To avoid possible misunderstandings at the result screen, it will visually be indicated for which lesion the risk was calculated. If there are multiple lesions present, multiple visual indications for multiple risk assessments may be used. If the lesion is not detected by the algorithm, no risk assessment is possible.

6 Warnings/Exclusions

To ensure personal safety and correct use, you should familiarize yourself fully with the following warnings and the entire contents of this booklet before using the application. Consult your healthcare professional or dermatologist if you experience unexpected operations or events with the service. Using a mobile application can distract you in situations where full concentration is required. Be aware of your surroundings while using the third-party application.

‍

Do not use SkinScreener while driving, during physical activity, or at places where the usage of the mobile device is prohibited!The application can generally be used anywhere it is possible to use a mobile device. The application may not be used in places where the use of a mobile device is prohibited. These places may include, but are not limited to, for example, certain areas in hospitals, in an aircraft, in a car if you are driving, and wherever else the use of a smartphone is prohibited or advised against.

‍

	The SkinScreener app does not replace a visit to your doctor! The SkinScreener app is a registered CE class IIa medical device and is used to support skin cancer risk assessment. SkinScreener is intended to be used in addition to common skin cancer prevention and regular dermatological check-ups. It does not provide a diagnosis nor replace regular consultations with a dermatologist.
	Do not use SkinScreener while driving, during physical activity, or at places where the use of mobile devices is prohibited! The SkinScreener app can generally be used anywhere it is possible to use a mobile device. This gives you a clear advantage in that you can perform a skin lesion scan and get a risk assessment almost anywhere and almost immediately. However, there are some exceptions. The SkinScreener app may not be used in places where the use of a mobile device is prohibited. These places may include, but are not limited to, for example, certain areas in hospitals, in an aircraft, in a car if you are driving, and wherever else the use of a smartphone is prohibited or advised against.
	Do not use the app if the camera/flash is not working! If the camera or flash on your mobile device is not working properly (broken, scratched, etc.) or if the mobile device becomes noticeably too hot, stop using the app.
	Do not use the app in the following cases: You have Fitzpatrick skin type V (dark brown) or VI (darkest brown); The lesion has low visual contrast to the surrounding skin area; The lesion is surrounded or covered by hair; The skin is sunburned; The lesion has been previously traumatized (excised/biopsied); The skin surrounding the lesion is not intact (open sores, ulcers, bleeding); The lesion is located on or next to anatomical structures such as ears, eyes, genitals, hair, mouth, nails, nostrils, nipples; The lesion is very close to visible scars or tattoos, or areas partly or fully covered with opaque or glittering substances like makeup, skin cream, sun cream, or similar; The lesion is on mucosal surfaces like lips, in the mouth, or in the genital region; The lesion is in or on a skinfold; The lesion is not on human skin; The scanned region is even partially covered by clothes; If the skin changes are less than 4 weeks old;

Any serious incident should be reported to the manufacturer and the competent authority. An incident can be reported via email: support@medaia.atlassian.net or per post: medaia GmbH, Am Eisernen Tor 5, 8010 Graz Austria.

A list of competent authorities can be found at the following link: https://ec.europa.eu/health/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf

‍

7 Using SkinScreener via SDK

Installing the App:

1. Go to the App Store or Google Play Store and search for the app provided by the integrator.
2. In the search result, tap on the relevant app.
3. Tap “GET” and then “INSTALL”.
4. If prompted, sign in to the App Store to complete the installation.

When the installation is complete, you will see the app’s icon on the home screen of your mobile device and the app is ready to be used.

Onboarding and Account Creation:

1. First of all please follow the instructions given by the third party application
2. When the app is started for the first time, onboarding screens with information about the services will open.
3. Scroll through the screens, read the information provided, and once finished, click “Continue”
4. Next, please follow the link to our Instructions for Use, Terms and Conditions, and Privacy Policy, and read them carefully.
5. After reading these files, if you choose to accept, please confirm by selecting the corresponding checkbox and pressing “Get Started”.
6. You will get to the “home” screen where you can find more information on the device as well as links to Instructions for Use, Help & Contact, Medical Information, Terms and Conditions, and Privacy Policy.

2) Scanning a Lesion

1. To scan a lesion, press the “+” button on the menu bar.
2. Aim your camera at the lesion and hold it steady at a distance of about 15cm (6 in) from the lesion. Press the “Scanning” button to trigger the recording of the photo.
3. If the scan was successful, the detected lesion appears with a border around it.
4. The associated risk assessment is shown by the app; please read the entire assessment carefully. SkinScreener classifies skin lesions into three different risk categories: LOW RISK (green), MEDIUM RISK (yellow), or HIGH RISK (red).
5. If multiple lesions are detected in the image, you can switch between them by tapping them.

3) Archive

1. To open the archive tap the “Archive” button in your menu bar.
2. In the archive, you can filter lesions by risk assessment and body region.
3. Press any lesion displayed on the archive screen to revisit that specific lesion’s risk assessment screen.
4. It might be the case that the third party application uses a shortcut to the archive. In such cases please refer to the instructions of the third party application.

4) Uninstalling

The product can be disposed of by uninstalling the third party app from the user’s mobile device. In such cases please refer to the instructions of the third party application.

‍

8 Troubleshooting

Solutions to common problems can be found below. If you still need any help with the application, please contact support@medaia.atlassian.net.

‍

‍

‍

9 Description of Symbols

	Warnings: Text marked with a warning symbol must be read before using the device.
	Manufacturer: The device is produced by the manufacturer, whose name and address are stated next to this symbol. Indicates the medical device manufacturer, as defined in Medical Device Regulation 2017/745.
	CE Mark: The device complies with Medical Device Regulation 2017/745.
	Consult electronic instructions for use: Indicates the need for the user to consult the electronic instructions for use.

‍

10 Privacy Policy

To use the SkinScreener API service, medaia GmbH needs to collect data from you. We very much value our customer’s privacy. To learn more about the data we collect, and how we process it, visit https://skinscreener.com/language/en/sdk-privacy/

11 Terms and Conditions

Before using the service, you must agree to the Terms and Conditions: https://skinscreener.com/language/en/sdk-terms-and-conditions/

‍

12 CE Mark and Product Availability

SkinScreener has received the CE marking as a class IIa medical device in accordance with the European MedicalDevices Regulation 2017/745 on medical devices on the 28th of November 2022.

The Instructions for Use are available in the languages of the respective countries where the product is on the market.  SkinScreener is available in the App Stores in the following countries:

• Austria
• Germany
• Ireland
• United Kingdom
• Spain
• France
• Italy
• Portugal
• Switzerland
• New Zealand

‍

13 Product and Manufacturer Information

Product Name: SkinScreener API

Product Version: v1.0

Software Version: v1.0

Basic UDI-DI: 912011561SKSC_APIW9

UDI-DI: 9120115610060

medaia GmbH
Am Eisernen Tor 5,
8010 Graz Austria
Web: https://skinscreener.com
Mail: support@medaia.atlassian.net