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The Sleep Apnea Notification Feature (SANF) is a software-only mobile medical application that analyzes Apple Watch sensor data to identify patterns of breathing disturbances suggestive of moderate-to-severe sleep apnea and provides a notification to the user. This feature is intended for over-the-counter (OTC) use by adults age 18 and over who have not previously received a sleep apnea diagnosis and is not intended to diagnose, treat, or aid in the management of sleep apnea. The absence of a notification is not intended to indicate the absence of sleep apnea.

The Sleep Apnea Notification Feature (SANF) is an over-the-counter mobile medical application (MMA) intended to identify patterns of breathing disturbances suggestive of moderate-to-severe sleep apnea and provide a notification to the user. SANF is intended to run on compatible iOS (e.g. iPhone, iPad) and Apple Watch platforms. Users set up SANF and view their health data on the iOS platform. Prior to use, users must undergo educational onboarding. SANF uses accelerometer sensor data collected by the Apple Watch to calculate breathing disturbance values while a user is asleep. Breathing disturbances describe transient changes in breathing patterns, such as temporary breathing interruptions.

Breathing disturbance data is analyzed in discrete, consecutive 30-day evaluation windows, If patterns consistent with moderate-to-severe sleep apnea are identified within the 30-day evaluation window, the user is notified. SANF provides visualizations depicting the user's breathing disturbance data over various time scales. SANF is not intended to provide instantaneous measurements. Instead, once activated, SANF runs opportunistically in the background receiving signals from Apple Watch sensors for processing.

Here's a summary of the acceptance criteria and study details for the Sleep Apnea Notification Feature (SANF), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.

This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a twonight monitoring period. It is intended for on demand use.

This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.

The Samsung Sleep Apnea Feature leverages wrist-worn PPG and actigraphy technology to create an over-the-counter (OTC) assessment of moderate-to-severe obstructive sleep annea for adults. When enabled, the device utilizes the wearable platform's PPG-derived SpO2 to monitor the user's sleep for repetitive, relative decreases in their blood oxygenation indicative of significant breathing disruptions associated with sleep apnea. Each on-demand assessment period requires two successful nights of observation within 10 days. After two qualifying assessment nights. the device will display the result on the wearable, after which, the user is guided to the phone for additional information. This provides the user with health information so that they may seek out medical attention. No raw signal data, including the SpO2 signal, is provided to the user nor is it able to be shared with clinicians.

The Samsung Sleep Apnea Feature consists of two mobile medical applications, one on the wearable (e.g., Samsung Galaxy Watch) and the other on the connected mobile phone (e.g., Samsung Galaxy Phone), both commercial off-the-shelf general computing platforms. Communications between the two devices are accomplished by encrypted Bluetooth/BLE connection via standard protocols for data transfer. The wearable component of the Sleep Apnea Feature runs in the wearable's operating system allowing it to verify the identification/qualification of the hardware, request SpO2/accelerometer signals via private APIs, display information on the screen display, and send data and receive commands to the phone Sleep Apnea Feature on the associated phone. The phone component of the Sleep Apnea feature provides a UI for onboarding, labeling, and status as well as the ability for device updates.

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

Acceptance Criteria and Device Performance

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