Search Results

The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation.

The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.

Device Description

The Nox Sleep System is intended for patients undergoing physiological measurements, for the assessment of sleep quality and the screening for sleep disorders.

The Nox Sleep System does not provide any alarms and is not intended to be used for continuous monitoring where failure to operate can cause injuries or death of the patient.

The basic Nox Sleep System consists of two recording/acquisition devices (Nox A1 Recorder and Nox C1 Access Point), a software running on a PC (Noxturnal PSG), an Android application (Noxturnal App) running on mobile platform, along with sensors and accessories. The system supports full Polysomnography (PSG) studies both in ambulatory and online/attended setups but also more simple sleep study setups, recording only few channels. The ambulatory sleep studies may take place in the clinic or in the home environment, but the online/attended sleep studies are only conducted in the clinical environment.

The Nox A 1 Recorder is a small battery-operated recording unit that is worn by the patient during the study. It records signals from patient applied sensors that connect to the unit but also supports recording of signals from auxiliary devices over Bluetooth. The Nox A1 Recorder allows for communication over Bluetooth with the Noxturnal App during ambulatory setup and with the Nox C1 Access Point during online setup. The recorder is intended to be worn over clothing.

New accessories and sensors as part of this submission are the Nox A 1 EEG 5 Lead Gold Electrode Cable and Nox A1 EEG Head Cable that are used for recording of EEG/EOG. These components are in direct contact with the patient.

The Nox C1 Access Point is a separate mains powered unit located remotely from the patient that allows for recording of signals from auxiliary devices. It supports communication over LAN/Ethernet to the Noxturnal PSG, and communication with the Nox A1 Recorder and Noxturnal App over Bluetooth. The Nox C1 Access Point is only used for online study setup and is thus not intended to be used in the home environment.

The Noxturnal App is used as a mobile interface to the Nox A1 Recorder and Nox C1 Access Point. The communications are via Bluetooth link. The app is normally used in the beginning of a sleep study, for basic tasks such as device configuration, starting a recording, checking the signal quality of signals being recorded and marking events during bio calibration.

The Noxturnal PSG is used for configuration of the Nox recording/acquisition devices, to download a study from ambulatory recording or to collect an online study. The software supports the viewing, retrieving, storing and processing of data recorded/collected, manual and automatic analysis and reporting on the results from the recorded studies. The purpose with the automatic scoring function in Noxturnal PSG is to assist the trained physician in the diagnosis of a patient. It is not intended to provide the trained physician with a diagnostic results. The type of automatic analysis events scored by Noxturnal PSG include: Sleep Stages (Wake, N1, N2, N3, REM), Apneas, Hypopneas, Apnea Cassification (Obstructive, Mixed and Central Apneas), Limb Movements, Periodic Limb Movements, SpO2 Desaturation Events. and potential Bruxism-Related Events.

The result of the automatic analysis/scoring must always be manually verified by the trained physician prior to diagnosis.

AI/ML Overview

The Nox Sleep System is designed to aid in the diagnosis of sleep disorders and assess sleep quality by measuring, recording, displaying, organizing, analyzing, summarizing, and retrieving physiological parameters during sleep and wake. The system includes automatic scoring functionalities for various sleep events, which are intended to assist trained medical professionals in diagnosis.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document presents separate sections for the performance of different automatic scoring algorithms rather than a single consolidated table. However, the information can be extracted and presented as follows:

Automatic Scoring Algorithm	Acceptance Criteria (Safety Endpoint/Justification)	Reported Device Performance
Bruxism Analysis	Detect at least 90% of oromandibular movements considered by a human expert to be bruxism-related events with 95% confidence (Sensitivity).	Sensitivity: 95.7% (95% CI 93.2% - 97.4%)
Specificity: 61.0% (95% CI 58.9% - 63.0%)
PPV: 34.6% (95% CI 32.0% - 37.3%)
NPV: 98.5% (95% CI 97.7% - 99.1%)
PLM Analysis	Interclass correlation (ICC) of 0.61 or greater and a bias unlikely to impact a diagnosis for the Periodic Limb Movement Index.	ICC for Periodic Limb Movement Index: 0.87
Respiratory Flow Analysis (AHI)	Not classifying patients with an AHI below 5 as having an AHI greater than or equal to 15 (95% confidence), AND
Not classifying patients with an AHI greater than or equal to 15 as having an AHI below 5 (95% confidence). Also, Cohen's kappa reported.	Cohen's Kappa for AHI (Cannula): 0.78
Cohen's Kappa for AHI (RIP flow): 0.62 (95% CI 0.59-0.66)
Cohen's Kappa for AHI (cRIP flow): 0.62 (95% CI 0.59-0.66)
Respiratory Flow Analysis (ODI)	(Implicitly similar to AHI, with Cohen's kappa reported)	Cohen's Kappa for ODI: 0.87
Apnea Classification	ICC comparable to what has been reported in scientific literature for Central Apnea Index (0.46).	ICC for Central Apnea Index: 0.91
Cohen's Kappa for Central Apnea Index: 0.89
Sleep Staging Analysis	Average accuracy of at least 60% when scoring wake epochs to ensure total sleep time measurement with 10% error or less (assuming 80% sleep efficiency).	Cohen's Kappa:

Ask a Question

Ask a specific question about this device

Page 1 of 1