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The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP)

The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only.

The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Wake, REM, Non-REM), ECG (reference only). The following summary metrics are calculated: SANSA-Apnea Hypopnea Index (sAHI), SANSA Apnea Hypopnea Index – Central (sAHIc), Sleep Times (Total Sleep Time, Total REM Time, Non-REM sleep time) and AHI during REM.

Recorded data is uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study.

The subject SANSA HSAT device consists of the same physical device components, intended use case, and operation, as the predicate SANSA HSAT device cleared under K244027. This submission updates the algorithm to update performance and add the ability to classify between Obstructive and Central Sleep Apnea events using an AI/ML classifier and present a summary metric, SANSA Apnea Hypopnea Index – Central (sAHIc). REM/NREM Classification and REM related sleep metrics were also added.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for SANSA HSAT:

Acceptance Criteria and Reported Device Performance

Study Details

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

• Sample Size: 325 subjects
• Data Provenance: The study was a "multisite in-lab comparison study." While specific countries are not mentioned, "multisite" implies data collected from multiple clinical locations. The study population details (racial and ethnic demographics) suggest data from diverse populations within a likely Western healthcare system (e.g., North America). The study is prospective in nature, as it involved patients undergoing in-lab comparison.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. It mentions a "PSG reference standard" and implicitly implies expert scoring for the Polysomnography (PSG) data. For a sleep study, this would typically involve Registered Polysomnographic Technologists (RPSGTs) and/or Board-Certified Sleep Physicians.

3. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. The common practice for establishing ground truth in comparison to a gold standard like PSG is that the PSG is scored according to established guidelines (e.g., AASM manual), and this score serves as the ground truth. It doesn't mention multiple scorers for the PSG data or a specific adjudication process beyond the "PSG reference standard."

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was done. The study focuses on the standalone performance of the device against a PSG reference standard rather than comparing human reader performance with and without AI assistance.

5. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The reported performance for sAHIc and REM/NREM classification directly reflects the performance of the SANSA HSAT device's algorithm in classifying events and sleep stages without human intervention other than the initial setup and data collection. The performance metrics are reported for the device itself (e.g., "The sensitivity of the Sansa device to detect AHIc ≥ 10...").

6. Type of Ground Truth Used

The type of ground truth used is expert consensus/Polysomnography (PSG) reference standard. PSG is widely considered the gold standard for diagnosing sleep-related breathing disorders and for sleep staging. The document explicitly states, "The performance of AHIc and NREM/REM sleep classification were compared to the PSG reference standard."

7. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only describes the clinical performance data derived from the test set of 325 subjects.

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

The document does not explicitly state how the ground truth for the training set was established. Given the nature of the device (AI/ML components), it is highly probable that the training data's ground truth was also established using scored PSG data, similar to the test set, but this is not directly specified in the provided text.

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