The BPM Core is a certified medical device. It has received the CE marking in accordance with the Medical Device Directive, ensuring compliance with European safety and performance standards. Below are the details of the clinical validations conducted for each of its features:
1. Blood Pressure Measurement The accuracy of the BPM Core was rigorously tested in clinical trials on a panel of adult men and women representative of the general population, including various ages, blood pressure levels, and arm circumferences ranging from 22 to 42 cm, according to the ISO 81060-2:2018/AMD 1:2020 standard.
- Methodology and Results: BPM Core measurements were compared to reference measurements (Korotkoff method) performed by two independent observers.
- Mean Deviation: The observed mean error is minimal: -0.6 mmHg for systolic and 0.1 mmHg for diastolic.
- Standards Met: These results exceed the requirements of the recognized international standard (ISO 81060-2:2018/AMD 1:2020), developed by the European Society of Hypertension and the British Hypertension Society.
2. Electrocardiogram (ECG) The BPM Core's ability to detect Atrial Fibrillation (AFib) or normal sinus rhythm was validated by comparison with a standard 12-lead ECG interpreted by a cardiologist.
- Performance on classifiable recordings:
- Sensitivity (Detection of AFib): 92%
- Specificity (Detection of normal rhythm): 98.4%
3. Electronic Stethoscope (Valvular Heart Disease) The stethoscope function of the BPM Core was designed to detect valvular heart disease (heart valve anomalies). Its accuracy was compared to the diagnosis of a cardiologist using Doppler echocardiography (the gold standard).
- Diagnostic Performance:
- Sensitivity (ability to detect stage 3 and 4 valvulopathy): 81.25%
- Specificity (ability to confirm the absence of anomalies): 95%
- Please Note: A specificity of 95% implies a "false positive" margin of 5%. This means that statistically, in 5% of users, the device might signal a valvular anomaly when the valves are healthy.
- Medical Comparison: Under optimal conditions of use, the performance of the BPM Core is comparable to that of a general practitioner performing traditional auscultation*.