AcuPebble® SA100

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

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 benefits Patient benefits

AcuPebble steps for use

How does it work?

  1. The AcuPebble SA 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. Referring consultants 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

Why use AcuPebble SA100?

  • Clinically validated automated diagnosis, providing an accurate result in minutes.
  • Comfortable and easy to use by patients, ensuring a more natural night’s sleep at home.
  • No risk of contagion, as the sensor can either be disposed of or easily disinfected.
  • Fully remote diagnosis, reducing waiting time and releasing capacity.

Regulatory information

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 and EU General Data Protection Regulation (GDPR).

Want to know more?

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