AcuPebble - Model SA100 - FDA Cleared Wearable Medical Device for Home Sleep Apnea Testing
From For Sleep Apnea
Clinically validated: AcuPebble SA100 automated sleep apnea test was validated in a powered clinical trial at the NHS Royal Free London hospital. Validated sleep study result equivalent to ambulatory gold-standard (multi-channel polygraphy followed by manual specialist interpretation). Validated result based on AHI and ODI 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.
Patient-friendly Design
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
How Does It Work?
- 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.
- The signals are transferred wirelessly to a mobile device, and then uploaded to a secure cloud platform.
- Sophisticated signal processing algorithms are applied to the signals to automatically extract the parameters used for sleep apnea detection.
- Healthcare professionals get an automatically generated full sleep study report within minutes, accessible via a user-friendly web application.
Detailed Sleep Report
- Overall 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
- Classification of apnea events
- Cardiac feature analysis
Benefits of AcuPebble SA100
- Automated detection of OSA, 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.
European Union
- CE mark certification for class IIa medical device issued by MTIC InterCert SRL in compliance with the European Medical Devices Directive (93/42/EEC).
- ISO 13485 certification issued by MTIC InterCert SRL.
- Registered with Competent Authorities and compliant with EU General Data Protection Regulation (GDPR).
UK
- CE mark certification for class IIa medical device issued by MTIC InterCert SRL in compliance with the European Medical Devices Directive (93/42/EEC).
- ISO 13485 certification issued by MTIC InterCert SRL.
- Compliant with NHS Data Security and Protection Toolkit (DSP Toolkit), NHS Clinical Risk Management Standard (DCB0129) and EU General Data Protection Regulation (GDPR)
USA
- Cleared by the US Food and Drug Administration (FDA) as a Class II medical device for home sleep apnea testing.
- Compliant with US HIPAA data protection regulations.
Clinical Evidence
Clinical trial at the NHS Royal Free Hospital (UK)
Compared AcuPebble SA100 to at-home multi-channel polygraphy followed by sleep specialist manual signal interpretation, the current ambulatory gold standard (powered sample of 150 patients). This trial proved:
- Diagnostic equivalence to current ambulatory gold standard for AHI and ODI based diagnosis on 3% and 4% desaturation criteria (94% PPV, 98% NPV).
- AcuPebble can be used at home, with 100% of patients able to complete the test without training or assistance.
- Results published in the BMJ Open.
University College London Hospital
Clinical trial at the NHS National Hospital for Neurology and Neurosurgery (UK)
Compared earlier AcuPebble version to Polysomnography software during in-clinic sleep test (30 subjects). This trial showed:
- 90% apnoea detection agreement with sleep specialist vs. Polysomnography software 12% agreement (7x more accurate).
- AcuPebble correctly diagnosed 100% of cases of moderate and severe sleep apnoea.
- Results published by BMJ Open in 2014.
Cost-effective solution
Increased number of tests conducted with the same resources.
- Simple, requires less staff time and resources per test.
- Reliable, reduces invalid tests that must be repeated.
- Efficient, reduces referral to diagnosis waiting times.
Contact us to get a detailed cost-effectiveness analysis for your sleep clinic.
Better patient experience
AcuPebble is designed to reduce the burden of sleep apnoea diagnosis for patients.
- Easy to use by patients at home, minimising trips to sleep clinic and overnight stays.
- Non-invasive device, ensuring a more natural night’s sleep.
- Reduces the waiting time for patients with a simpler (and faster) patient pathway.
Fully automated diagnosis
Using AcuPebble SA100 fully automates the diagnosis process.
- Patients complete the study by following the instructions in the mobile app.
- The study is uploaded by the patient and data is automatically analysed.
- A clinically validated sleep report is automatically generated and sent to the clinician within minutes.
Patient Experience
Easy to use
- Patients simply peel off the adhesive and place AcuPebble on their neck.
- Includes simple step-by-step instructions in the accompanying mobile app.
- Patients do not need to be trained to use the device by a healthcare professional.
Diagnose patients remotely
Increased number of tests conducted with the same resources.
- The device can be sent to patients (and returned) by post, avoiding unnecessary trips.
- Less time off work needed, reducing the associated socio-economic impact.
- No risk of contagion, as the sensor can either be disposed of or easily disinfected.
Comfortable sleep test
A non-invasive test, allowing patients to have a more natural sleep.
- Patients sleep in the comfort of their own bed, without being attached to any leads or wires.
- Patients have less anxiety and fear than associated with a hospital medical test.
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