Indications for Use

United States

Queen of Hearts™ (ACS AI ECG Model)

Queen of Hearts™ (ACS AI ECG Model) is a software as a medical device (SaMD) intended for analyzing resting 12-lead ECGs in patients (age ≥22 years) presenting with symptoms suspicious for an acute coronary syndrome in whom referral to a cardiologist for early invasive diagnostic testing and clinically indicated coronary intervention may be considered. When using the device, healthcare professionals should take the following factors into account:

• The device should be used in conjunction with the standard of care in ED and EMS settings for improved evaluation of patients with potential acute coronary syndromes.
• Device use is targeted for potential acute coronary syndrome patients based on presenting clinical characteristics in whom the initial ECG is interpreted as low or indeterminate risk.
• A negative device output does not exclude an acute coronary syndrome, STEMI, STEMI-equivalent, acute coronary occlusion, or other cardiac conditions, and the standard of care should not be modified in response to a negative device output.
• No therapeutic decisions should be made based solely on the device output, and device findings should be reviewed by a qualified cardiology specialist.

Europe

PMcardio OMI AI ECG Model

The OMI AI ECG Model is designed to assist qualified healthcare professionals in interpreting 12-lead resting ECGs. The OMI AI ECG Model is intended for use by healthcare professionals trained in ECG interpretation in a professional healthcare environment such as a pre-hospital or in-hospital environment. The indications for use focus on the assessment of ECGs of adult patients presenting with symptoms of acute coronary syndrome for the presence of occlusion myocardial infarction (OMI). The OMI AI ECG Model interpretation results are not intended to be the sole means of diagnosis. The device’s output is to be considered advice only and to be interpreted in conjunction with the health care professional’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

PMcardio Core AI ECG Model

Core AI ECG Model is designed to assist qualified healthcare professionals in interpreting 12-lead resting ECGs in subjects over 18 years of age. Core Diagnostics AI Mode is intended for use by healthcare professionals trained in ECG interpretation in a professional healthcare environment such as hospitals, emergency medical services and other healthcare facilities.

Indications for use include patients presenting with common cardiovascular symptoms, such as Chest pain, Palpitations, Shortness of breath, Syncope. Additionally, Core AI ECG Model can be used in all situations when an ECG exam is performed or gathered by the intended users including routine examinations, pre-operative testing, sport exams and vitals testing in the urgent care setting.

Core AI ECG Model interpretation results are not intended to be the sole means of diagnosis. The device’s output is to be considered advice only and to be interpreted in conjunction with the health care professional’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. The device is designed to be integrated into medical devices or other IT healthcare solutions by a healthcare solution operator to build web, mobile or other types of applications.