Search Results

The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription. DPCF is available over-the-counter (OTC) for users with prism in their eyeglass prescription. When a prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro. DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimension (i.e., base-up, base-down, base-in, base-out), per eye.

The Digital Prism Correction Feature (DPCF) is intended to provide a high quality visual experience in Apple Vision Pro spatial computing applications for users with a prism prescription. Specifically, the DPCF is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription, in the horizontal and/or vertical dimensions. DPCF fulfills the prism part of an eyeglass prescription. When an eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), DPCF fulfills the prism part of the prescription, while prescription optical inserts fulfill the other parts of the prescription. The DPCF achieves its intended use by converting a user's prism prescription into digital image adjustment parameters that are utilized by the spatial computing image system to automatically provide digital image adjustments in horizontal and/or vertical dimensions in accordance with a user's prism prescription. At this time, DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e, base-up, base-down, base-in, base-out), per eye. The DPCF is available over-the-counter (OTC).

The Digital Prism Correction Feature (DPCF) is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription. DPCF is available for users with prism in their eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), which can be fulfilled by optical inserts, the DPCF fulfills the prism part of the prescription while using Apple Vision Pro. DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e., baseup, base-down, base-in, base-out), per eye.

The Digital Prism Correction Feature (DPCF) is intended to provide a high quality visual experience in Apple Vision Pro spatial computing applications for users with a prism prescription. Specifically, the DPCF is software that is intended to provide digital image adjustments in Apple Vision Pro in accordance with a user's prism prescription, in the horizontal and/or vertical dimensions. DPCF fulfills the prism part of an eyeglass prescription. When an eyeglass prescription also includes other parts (e.g., sphere, cylinder, ADD), DPCF fulfills the prism part of the prescription, while prescription optical inserts fulfill the other parts of the prescription. The DPCF achieves its intended use by converting a user's prism prescription into digital image adjustment parameters that are utilized by the spatial computing image system to automatically provide digital image adjustments in horizontal and/or vertical dimensions in accordance with a user's prism prescription. At this time, DPCF supports prism prescriptions up to 7.75 Prism Diopters (PD) in the horizontal and/or vertical dimensions (i.e. base-down, base-in, base-out), per eye.

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.

The Hearing Aid Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Hearing Aid Feature utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.

The Hearing Aid Feature (HAF) is a software-only device that is comprised of a pair of software modules which operate on two separate required products: (1) HAF iOS Application on a compatible iOS product, and (2) HAF software (i.e., firmware) on the Apple AirPods Pro 2. Refer to Figure I, middle and right, respectively, The AirPods Pro 2, formerly named AirPods Pro (2nd generation), supported this granting and are hereafter simply referred to as "AirPods Pro" in this document. The HAF iOS Application guides users through the onboarding and setup process for the HAF. The process is self-guided by the user and includes step-by-step instructions and informational content (e.g. warnings, instructions for use). To initiate HAF setup, the user must select a saved audiogram from the iOS HealthKit. Once the audiogram has been imported by the HAF, the feature will configure the amplification for the user's audiogram based upon Apple's proprietary fitting formula. Once the initial set-up is complete, users can listen with the HAF using the AirPods Pro and refine their settings. Fine tuning is facilitated by user controls on the iOS device that can adjust amplification, tone, and balance. A user can access the fine tuning settings at any time after setting up the HAF. The HAF settings are transferred to the HAF Firmware Module on the AirPods Pro. The HAF Firmware Module utilizes the general purpose computing platform features of the AirPods Pro, including the microphone, speakers, amplifiers, and audio processing software, to process incoming sound and provide amplification at a specific frequency and gain based on the user's custom settings. The user's custom settings are stored on the HAF Firmware Module and will be available even when the AirPods Pro are not connected to the iOS device.

The IRNF is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user's risk factors the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

IRNF 2.0 is comprised of a pair of mobile medical apps - One on Apple Watch and the other on the iPhone. IRNE 2.0 is intended to analyze pulse rate data collected by the Apple Watch PPG sensor on Apple Watch Series 3-8, Series SE, and Apple Watch Ultra to identify episodes of irregular heart rhythms consistent with AFib and provides a notification to the user. It is a background screening tool and there is no way for a user to initiate analysis of pulse rate data. IRNF 2.0 iPhone App is part of the Health App, which allows users to store, manage, and share health and fitness data, and comes pre-installed on every iPhone. IRNF 2.0 Watch App refers to the tachogram classification algorithm, confirmation cycle algorithm, and the AF notification generation. If an irreqular heart rhythm consistent with AFib is identified, IRNF 2.0 Watch App will transfer the AFib notification to IRNF 2.0 iPhone App through HealthKit sync. In addition to indicating the finding of signs of AFib, the notification will encourage the user to seek medical care. IRNF 2.0 iPhone App contains the on-boarding and educational materials that a user must review prior to enabling AFib notifications. IRNF 2.0 iPhone App is designed to work in combination with IRNF 2.0 Watch App and will display a history of all prior AFib notifications. The user is also able to view a list of times when each of the irregular tachograms contributing to the notification was generated.

The Atrial Fibrillation (AFib) History Feature is an over-the-counter ("OTC") software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of atrial fibrillation (AFib). The feature opportunistically analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides the user with a retrospective estimate of AFib burden (a measure of the spent in AFib during past Apple Watch wear). The feature also tracks and trends estimated AFib burden over time, and includes lifestyle data visualizations to enable users to understand the impact of certain aspects of their AFib. It is not intended to provide individual irregular rhythm notifications or to replace traditional methods of diagnosis, treatment, or MFib. The feature is intended for use with the Apple Watch and the Health app on iPhone.

The Atrial Fibrillation History Feature (AFib History Feature) is comprised of a pair of mobile medical apps - one on Apple Watch and the other on the iPhone. The AFib History Feature is intended to analyze pulse rate data collected by the Apple Watch PPG sensor on Apple Watch Series 4. Series 5. and SE to identify episodes of irregular heart rhythms consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). The AFib History Feature uses PPG pulse rhythm data from compatible Apple Watches. Apple Watch uses green LED lights paired with light-sensitive photodiodes to detect relative changes in the amount of blood flowing through a user's wrist at any given moment. When the heart beats it sends a pressure wave down the vasculature, causing a momentary increase in blood volume when it passes by the sensor. By monitoring these changes in blood flow, the sensor detects individual pulses when they reach the peripherv and thereby measure beat-to-beat intervals. The AFib History Feature iPhone App is part of the Health App. which allows users to store, manage, and share health and fitness data, and comes pre-installed on every iPhone. The AFib History Feature provides users visualizations of AFib burden estimate data alongside clinically relevant lifestyle data and presents estimates of AFib burden in three different ways. These visualizations empower users to observe and understand the impact of lifestyle on their AFib burden, and to better understand their condition generally. - · Weekly Estimate an estimate of the amount of time a user was in Atrial Fibrillation over the past calendar week during watch wear, presented to the user as a percentage. - Day of Week Estimate an estimate of the amount of time a user was in Atrial Fibrillation on each day of the week over the previous 42 days during watch wear, presented to the user as a percentage. That is, all Mondays over the past 42 days, all Tuesdays over the past 42 days. - Time of Day Estimate an estimate of the amount of time a user was in Atrial Fibrillation on 4-hour segments of the day over the previous 42 days during watch wear, presented to the user as a percentage. That is, all 12 am - 4 am segments over the past 42 days, all 4 am - 8 am segments over the past 42 days. The AFib History Feature is intended to serve as an extension of the predicate Irregular Rhythm Notification feature, but has been optimized for users with a diagnosis of Afib.

The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user's risk factors the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

Irregular Rhythm Notification Feature 2.0 (IRNF 2.0) is comprised of a pair of mobile medical apps - One on Apple Watch and the other on the iPhone. IRNF 2.0 is intended to analyze pulse rate data collected by the Apple Watch PPG sensor on Apple Watch Series 3. Series 4. Series 5. and SE to identify exisodes of irreqular heart rhythms consistent with AFib and provide a notification to the user. It is a background screening tool and there is no way for a user to initiate analysis of pulse rate data. IRNF 2.0 iPhone App is part of the Health App. which allows users to store, manage, and share health and fitness data, and comes pre-installed on every iPhone. IRNF 2.0 Watch App refers to the rhythm classification algorithm, confirmation cvcle algorithm, and the AFib notification generation. If an irreqular heart rhythm consistent with Afib is identified and confirmed through the confirmation cycle, IRNF 2.0 Watch app will notify the user and transfer the AFib notification to the iPhone App through HealthKit sync. In addition to indicating the finding of signs of AFib, the notification will encourage the user to seek medical care. IRNF 2.0 iPhone App contains the onboarding and educational materials that a user must review prior to use. IRNF 2.0 iPhone App is designed to work in combination with IRNF 2.0 Watch App and will display a history of all prior AFib notifications. The user is also able to view a list of times of the irreqular rhythms contributing to the notification.

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (no detected AF with heart rate 100-150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.

The ECG 2.0 app comprises a pair of mobile medical apps - one on Apple Watch and the other on the iPhone. The ECG Watch app analyzes data collected by the integrated electrical sensors on a compatible Apple Watch to generate an ECG waveform similar to a Lead I. calculate average heart rate, and provide a rhythm classification to the user for a given 30 second session. When a user opens the ECG Watch app while wearing the Watch on one wrist, and places the finger of the opposite hand on the digital crown, they are completing the circuit across the heart which begins a recording session. Once the recording session is complete, the ECG Watch app performs signal processing, feature extraction and rhythm classification to generate a session result. The resulting classification and average heart rate for the session, along with educational information, will be displayed to the user within the ECG Watch app. The ECG iPhone app contains the on-boarding and educational materials that a user must review prior to taking an ECG reading. The ECG iPhone app is included in the Health App, which allows users to store, manage, and share health and fitness data, and comes pre-installed on every iPhone. The ECG 2.0 app expands the classifiable heart range, introduces new classification results, and introduces minor, non-userfacing algorithm updates. These changes will be reflected in both the Apple Watch app, and also on the corresponding iPhone app within the Health App.

The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user's risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment. The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

The Irregular Rhythm Notification Feature comprises a pair of mobile medical apps, one on Apple Watch and the other on the iPhone. The Irregular Rhythm Notification Feature analyzes pulse rate data collected by the Apple Watch photoplethysmograph (PPG) sensor to identify episodes of irregular heart rhythms consistent with atrial fibrillation (referred to in this document as AF or AFib) and provides a notification to the user. It is a background screening tool and there is no way for a user to initiate analysis of pulse rate data. The Irregular Rhythm Notification Feature is part of the Health App, which allows users to store, manage, and share health and fitness data, and comes pre-installed on every iPhone. Users must opt-in and go through onboarding prior to use of the Irregular Rhythm Notification Feature. The Irregular Rhythm Notification Feature is not intended to diagnose atrial fibrillation, and is not intended to be used to guide clinical treatment or care.

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.

The device (ECG App) comprises a pair of mobile medical apps — one on Apple Watch (the Watch App) and the other on the iPhone (iPhone App) - intended to record, store, transfer, and display a single lead ECG signal similar to a lead I. The ECG Watch App is intended to analyze this single lead data and detect the presence of atrial fibrillation (referred into this document as AFib or AF) and sinus rhythm in adults. It is also intended to acquire and analyze the single lead ECG recordings for display on the iPhone. The ECG iPhone App is included in the Health App, which is intended to store, manage, and share health and fitness data, and comes pre-installed on every iPhone.