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The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders. The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial accelerometer data, ambient light and acoustic data. With help of the ComfortOxyRing, the device records plethysmographic data, as well as SpO2, heart rate and activity data. The HomeSleepTest calculates and reports to clinicians EEG/EOG/EMG, sleep stages, SpO2, plethysmography, pulse rate and snoring level. Based on this, the HomeSleepTest indices derived parameters, such as autonomic arousal (based on plethysmogram of ring), oxygen desaturation index and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters, to aid in determining sleep quality and quantity. HomeSleepTest data is not intended to be used as the sole or primary basis for diagnosing any sleep disorders, or sleep-related breathing disorders, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The HomeSleepTest is not intended for use in life-support and monitoring systems. The HomeSleepTest and its accessories are not intended for patients requiring monitoring and intensive care. The HomeSleepTest is a prescription device indicated for adult patients aged 21 years and over.

The HomeSleepTest is used to record vital signs to determine a hypnogram (sleep profile) and sleep parameters that can be helpful in objectively determining sleep quality and quantity. The HomeSleepTest is available in a standard HomeSleepTest (HST) version and a HomeSleepTest REM+ (HST REM+) version. The only difference between the two basic devices is the measuring point of the outer electrodes on the forehead. HomeSleepTest refers to both versions of the device. Furthermore, the HomeSleepTest can be used to detect the patient's activity, head position and snoring. A recording with the HomeSleepTest is initialized in the clinic/practice. For this purpose, the patient is given the HomeSleepTest and a tablet to take home. The recording can thus be carried out independently in the home environment. Immediately after recording, the data is automatically transferred to the HST cloud. The physician has access to this data via the HST cloud where they can analyze the data via the HST cloud in DOMINO and generate a report. A tablet app with video sequences supports the patient in correct application and guides them through the required biocalibration of the system. Once the test is started, all data from the HomeSleepTest is recorded via Bluetooth. The HomeSleepTest records nine signals (3 x frontopolar EEG, 2 x EOG, EMG, snoring, activity and head position). Snoring and snoring rhythm are recorded via the tablet's microphone. Head position, movement and light support information about time in bed (TIB) and other sleep-related parameters. After completion of the measurement the next morning by the patient, the data is automatically uploaded to the HST cloud where it can be analyzed with help of DOMINO software. After the data has been successfully transferred to the cloud, an exchange with the physician is possible via the feed-back function. It is also possible to release a new measurement for this patient, so that recordings can be made over several nights to capture variability. An overview of all measurements is available to the physician in the HST Cloud. A chat area is used for communication between doctor and patient. In the cloud-based evaluation software, both the pre-evaluation and the raw data of the measurement should be analyzed or edited in an AASM compliant manner. A simple report is available immediately after uploading the measurement. However, the recorded data must still be verified by a physician: for the detailed report (standard report), the measurement is opened in the DOMINO software and scored manually. After evaluation, the standard report is also available in the overview and provides additional information on the various sleep parameters.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 30 adult patients.
• Data Provenance: The study was designed as a prospective and open validation study. The country of origin is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: At least one trained and certified scorer. For interrater variability, two scorers were used.
• Qualifications: "trained and certified scorer". Specific experience level (e.g., "radiologist with 10 years of experience") is not detailed.

4. Adjudication Method for the Test Set

• The text states: "The measurements of the PSG device and the HST with ComfortOxyRing were evaluated manually according to the current AASM guidelines in random order by a trained and certified scorer."
• For the interrater variability study, "The HST sleep stages were scored by two scorers." The agreement between them was then assessed.
• There's no explicit mention of an adjudication method like 2+1 or 3+1 for resolving discrepancies in the primary ground truth establishment. The initial comparison against PSG manually scored by "a scorer" suggests a single-expert scoring for the ground truth, with further inter-rater assessment for the HST device itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described as such. The study focused on validating the HomeSleepTest against a gold standard PSG (SOMNOscreen plus) and assessing inter-rater variability for HST scoring. While multiple readers were involved in assessing inter-rater agreement for HST, this is not presented as a comparative effectiveness study of human readers with and without AI assistance to quantify improvement.
• Effect Size: Not applicable, as an MRMC comparative effectiveness study with AI assistance was not reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance evaluation was conducted for the automated analysis.
• The "pre-evaluation (automated analysis) of the HST sleep stages" was compared to the manually scored measurements of the reference PSG device.
• Performance: The concordance for the automated analysis was 53.7%, with a Cohen's kappa of 0.40, meeting a pass criterion of 50.0%.

7. The Type of Ground Truth Used

• The primary ground truth used was expert consensus / manual scoring based on the gold standard PSG (SOMNOscreen plus) measurements, according to current AASM guidelines. This is essentially expert consensus against a recognized clinical standard.

8. The Sample Size for the Training Set

• The document does not provide information regarding the sample size used for the training set of the HomeSleepTest's algorithm.

9. How the Ground Truth for the Training Set Was Established

• The document does not provide information on how the ground truth for the training set was established. The clinical performance section focuses solely on the validation/test set.

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