AcuPebble® SA100

The first medical device to obtain the CE mark for the automated diagnosis of Obstructive Sleep Apnoea

Overview Evidence Patients

Clinically validated diagnosis

AcuPebble SA100 automated sleep apnoea diagnosis was validated in a powered clinical trial at the NHS Royal Free London hospital.

  • Validated diagnosis equivalent to ambulatory gold-standard (multi-channel polygraphy followed by manual specialist interpretation).
  • Validated AHI and ODI based diagnoses for both 3% and 4% desaturation criteria with high accuracy (94% PPV, 98% NPV).
  • Proven usability of the device, with 100% of the patients in the trial able to complete the test without training.

Clinical Evidence


AcuPebble sensor with box and adhesives

Patient-friendly design

All aspects of AcuPebble SA100 have been designed with the patient in mind:

  • Easy to use, as simple as peeling off an adhesive and putting it on.
  • Non-invasive, allows patients to have a more natural sleep at home.
  • No training required, avoids unnecessary trips to the clinic.

More about patient benefitsPatient benefits


AcuPebble steps for use

How does it work?

  1. The AcuPebble SA100 sensor is attached at the base of the neck to record the sounds generated by the patient’s respiratory and cardiac functions.
  2. The signals are transferred wirelessly to a mobile device, and then uploaded to a secure cloud platform.
  3. Sophisticated signal processing algorithms are applied to the signals to automatically extract the parameters used for sleep apnoea diagnosis.
  4. Healthcare professionals get an automatically generated full diagnosis report within minutes, accessible via a user-friendly web application.

Detailed sleep report

Diagnosis Details
  • Overall diagnosis (test result and severity)
  • AHI obtained from flow reductions and 3% desaturation (as per current AASM criteria)
  • AHI obtained from flow reductions and 4% desaturation
  • ODI using 3% desaturation
  • ODI using 4% desaturation
  • All parameters obtained using estimation of sleep time
Additional information
  • Classification of apnoea events
  • Respiratory and cardiac feature analysis

Benefits of AcuPebble SA100

  • Automated diagnosis, providing an accurate result in minutes.
  • Fully remote testing, reducing hospital visits and risk of contagion.
  • Cost-effective, requiring less staff time and fewer resources per test.
  • Comfortable to wear, ensuring a more natural night’s sleep at home.

Regulatory information

AcuPebble SA100 is approved for use in the following regions.

CE mark CE mark certification for class IIa medical device issued by MTIC InterCert SRL in compliance with the European Medical Devices Directive (93/42/EEC).
MTIC ISO 13485 certified ISO 13485 certification issued by MTIC InterCert SRL.
Registered with Competent Authorities Registered with Competent Authorities and compliant with EU General Data Protection Regulation (GDPR).
CE mark CE mark certification for class IIa medical device issued by MTIC InterCert SRL in compliance with the European Medical Devices Directive (93/42/EEC).
MTIC ISO 13485 certified ISO 13485 certification issued by MTIC InterCert SRL.
NHS logo Compliant with NHS Data Security and Protection Toolkit (DSP Toolkit), NHS Clinical Risk Management Standard (DCB0129) and EU General Data Protection Regulation (GDPR)

UK

NIA logo Selected by the award-winning NHS Innovation Accelerator as one of the 12 innovations to be supported to scale across the NHS in England.
FDA clearance Cleared by the US Food and Drug Administration (FDA) as a Class II medical device for home sleep apnoea testing.
HIPAA compliant Compliant with US HIPAA data protection regulations.



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