Ada Assess Instructions for Use

Manufacturer Information

Ada Health GmbH
Neue Grünstraße 17
10179 Berlin

Phone: +49 030 600 31987
E-mail: [email protected]
Website: https://ada.com

This version of the Instructions for Use applies to software versions 3.0 or later of ‘Ada Assess’, a medical device manufactured by Ada Health GmbH. (Note: Ada Assess may not be regulated as a medical device in all jurisdictions.)

1. What is Ada Assess? (Intended purpose)

Ada Assess is AI-based health assessment software intended to provide personal health insights and guidance. The insights and guidance provided include an overview of possible conditions, an estimated likelihood of each condition, and navigation to the appropriate level of care.

After an assessment, the user can share their results with healthcare providers, who may consider this information for clinical decision-making.

Ada Assess is not a substitute for advice from a healthcare professional and does not provide a final medical diagnosis.

2. Use Specifications

2.1. When Can I Use Ada Assess? (Specification of indications)

The device is designed to cover a wide range of medical conditions that can cause symptoms and, therefore, would not be feasible to list all specific indications for the device. Ada Assess is intended to provide a non-emergency symptom assessment to users at age 16 or above or under 16 years by their legal guardians.

2.2. Who Can Use Ada Assess? (Intended user)

Ada Assess has been designed for users above 16 years of age, and its underlying medical knowledge has been developed for all age groups. It has been designed for lay person use, no medical training is required. It is intended to be used in a home, or normal layperson user living environment, under the physical, social and technical conditions that allow the user to use standard personal computing and smartphone technologies. It can be used on any modern smartphone or computer. It can be used as a standalone tool, or linked to a healthcare provider’s information systems. The target population for the medical device is individuals above the age of 16 who are experiencing symptoms and who are seeking information about potential conditions that may be causing those symptoms. The intended population for this device includes vulnerable groups, specifically elderly people and pregnant women.

2.3. Who Should Not Use Ada Assess? (Contra-indications)

Ada Assess should not be used in a medical emergency. It should not be used in a setting, where a clear understanding of the questions is not ensured (e.g. lack of knowledge in the provided languages, impaired consciousness). Age under 16 years is listed as a relative contraindication - the legal guardian of a person under 16 years of age may conduct and do an assessment on their behalf.

3. Device Overview

Ada Assess is a software application that provides users with health information relevant to medical findings they are currently experiencing (e.g. observed symptoms or other health related factors such as existing conditions or previous procedures). The user interacts with ‘Ada’ in a conversational style, similar to a chatbot.

Upon initiation of the conversational flow the user is requested to enter relevant information about themselves. If their healthcare provider or insurer is partnered with Ada Health GmbH, some of the user’s relevant information can be directly accessed from their provider or Electronic Health Record (EHR) via Single Sign-On (SSO).

Following this, the user is asked to enter the finding(s) that they are concerned with into the application and are guided through a logical sequence of questions, intended to identify possible conditions that could be causing the finding(s) specified by the user.

At the end of the health assessment the user is provided with a report (hereinafter referred to as 'assessment report') that includes a list of all present and absent findings (i.e. the information entered during the onboarding phase and the answers to all questions from the question flow), along with a list of the most likely conditions to be causing this set of findings, and an ‘overall’ advice level based on the health assessment plus an advice level for each suggested condition. There are eight advice levels, each overall advice level has a corresponding text that is shown to the user while condition-specific advice levels are simplified to one of three options - this is outlined in the table below.

The assessment report can be downloaded as a PDF document. The user can also choose to share their assessment report with a healthcare provider.

Depending on the configuration of the device, Ada Assess can offer the user multiple options after presenting the assessment report. If the ‘Connect’ module is enabled, Connect provides the user an opportunity to review and select relevant partner healthcare services, studies or information. If the ‘Handover’ module is enabled, Ada Assess can give the user the option to share their assessment report with their healthcare provider (Ada Assess will ask the user for specific consent for sharing this data with the healthcare provider).

Caution! Ada Assess has a roadblock feature for certain emergency situations or conditions such as suicidal ideation and chest pain suggested of a heart attack. This means that if a user presents with one of these symptoms or confirms having one during the Question Flow, Ada Assess will immediately stop the assessment and inform the user that this is a serious condition and they need to seek medical attention right away. The user can still proceed with the assessment if they choose to.

4. User Safety

4.1. Limitations

Ada Assess should not be used as a substitute for advice from a healthcare professional and does not provide a final medical diagnosis.

4.2. Precautions

• The assessment report is produced on the basis of the information that you provide. Please ensure that your provided answers are true and accurate. Ada Assess works best when the symptoms that are most worrying to the user are entered, such as the ones that have appeared most recently or most rapidly. Inaccurate or false answers can lead to the delivery of an assessment report that is not suitable for you (i.e. inaccurate advice levels). If you choose to follow these inaccurate advice levels, the efficacy of the medical device is no longer ensured.
• When accessing Ada Assess in a web browser, ensure you are using a supported browser (see section 7) which is up to date with the latest stable release.
• When accessing Ada Assess from a mobile device, ensure you are using a supported operating system (see section 7) which is up to date with the latest stable release and security patches.

4.3. Safety Warnings

• Do not use Ada Assess in an emergency situation. In the case of an emergency, contact your local medical emergency services.
• Do not use Ada Assess as a substitute for the advice of a healthcare professional.
• If your symptoms get worse during an assessment, interrupt the assessment and consult a healthcare professional.
• Ada Assess is not a diagnostic tool. If you are concerned about any symptoms, please consult a healthcare professional regardless of the outcome of the assessment.
• Do not wait to seek medical care, if you are concerned about your health. Waiting may lead to delayed care and cause deterioration of your health status.

4.4. Side Effects

• Use of digital health tools may be related to increased health anxiety, particularly if the conditions suggested to the user include distressing or sensitive conditions.
• Use of digital health tools may be related to increased self-surveillance and normalisation of health-seeking behaviour.

4.5. Residual Risk

• Ada Assess provides a list of conditions that it has identified as possible causes for your symptoms. This is not an exhaustive list. You may have a condition that is not suggested. Please consult a healthcare professional if you are concerned about your health status. Waiting may lead to delayed care and cause deterioration of your health status.
• Ada Assess may suggest sensitive or upsetting conditions in the assessment report. Do not complete an assessment, if you do not wish to learn information that may cause distress or anxiety.

5. Expected Clinical Benefit

Ada Assess is intended to provide timely and accurate assessment of symptoms for the lay user, aiding in appropriate care navigation based on an initial assessment of the user’s symptoms, facilitating conversation and saving time during healthcare consultations by providing a preliminary analysis of symptoms, and informing the identification of less common and rare diseases based on the user's symptoms.

6. Performance Characteristics of the Device

The performance of the device depends on the underlying performance of a software module of Ada Assess that includes, among other components, the medical reasoning engine. The performance of the module has been shown to be state of the art in testing against medical doctors and other on- market symptom assessment applications. Every update of the module is tested against a large number of clinical case scenarios to ensure that performance is always maintained within defined acceptance criteria for condition suggestion accuracy and for the proportion of relatively lenient or over-cautious advice about onward care. The results of the accuracy, leniency and over-cautiousness tests must pass certain conditions (within defined thresholds with a confidence of >95%) before a new software module is approved for release.

7. Compatibility Requirements

The Ada Assess is available as an SDK (software development kit) in two options:

8. Get In Touch

8.1. Report a Safety Concern

If you would like to report a safety concern that has occurred in relation to our device, please email our Medical Safety team at [email protected].

In addition to the notification of our Medical Safety team, serious incidents, i.e. death, serious deterioration of health or public health threats, shall be reported to the competent authority for medical devices of your country.

8.2. Customer Support

If you have questions or require technical support, please email our Customer Service team at [email protected] or fill out the contact form on https://ada.com/contact/support/.

To request a physical copy of this manual, please email our Customer Service team at [email protected]. The physical copy of this manual will be sent to you at no additional cost within seven calendar days after receipt of your request.