Who is the manufacturer of IRNF App?

Apple, Inc. filed the 510(k) submission for IRNF App (K212516).

What is the FDA product code for IRNF App?

QDB. It is classified under 21 CFR 870.2790 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for IRNF App?

510(k) clearance (submission type: Traditional).

Does IRNF App use AI or machine learning?

Yes. IRNF App (K212516) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for IRNF App?

Irregular Rhythm Notification Feature (DEN180042).

Who can help prepare an FDA 510(k) submission like IRNF App?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like IRNF App get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

IRNF App

K212516 · Apple, Inc. · QDB · Oct 22, 2021 · Cardiovascular

Device Facts

Record ID	K212516
Device Name	IRNF App
Applicant	Apple, Inc.
Product Code	QDB · Cardiovascular
Decision Date	Oct 22, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2790
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Atrial Fibrillation Detection	Convolutional neural network	—	Sensitivity: 88.6%, Specificity: 99.3%	Over 2500 subjects and over 3 million pulse rate recordings; split into Training, Validation, Testing, and Sequestration sets.	—	Clinical study of 573 participants ages 22 and older.	—

Indications for Use

Photoplethysmograph analysis software for over-the-counter use. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Device Story

Software-only mobile application (Apple Watch and iPhone) analyzing pulse rate data from Apple Watch PPG sensor. Operates as background screening tool; no user-initiated analysis. Algorithm processes pulse data to identify irregular rhythms suggestive of AFib; confirms findings via internal confirmation cycle. If AFib signs confirmed, Watch app notifies user and syncs data to iPhone Health app. iPhone app provides educational materials, notification history, and irregular rhythm timestamps. Used by consumers in non-clinical settings; encourages users to seek medical care upon notification. Benefits include opportunistic AFib screening for asymptomatic users.

Clinical Evidence

Clinical study of 573 participants (age 22+) with and without AFib history. Subjects wore Apple Watch and reference ECG patch for up to 13 days. Primary endpoint analysis (n=432) showed 88.6% sensitivity (124/140 AFib-positive subjects correctly identified) and 99.3% specificity (290/292 AFib-negative subjects correctly identified).

Technological Characteristics

Software-only mobile application. Uses PPG sensor data from Apple Watch (Series 3, 4, 5, SE). Rhythm classification algorithm utilizes a convolutional neural network (CNN) architecture. Data processed via background screening; syncs via HealthKit. No hardware materials; software-based sensing.

Indications for Use

Indicated for adults 22 years and older without a prior diagnosis of atrial fibrillation (AFib). Intended for OTC use with Apple Watch to analyze pulse rate data for irregular rhythms suggestive of AFib. Not intended for use on every episode of irregular rhythm; provides opportunistic notifications when sufficient data are available during periods of user stillness. Supplements AFib screening; not a replacement for traditional diagnosis or treatment.

Regulatory Classification

Identification

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Special Controls

In combination with the general controls of the FD&C Act, the photoplethysmograph analysis software for over-the-counter use is subject to the following special controls: - 1. Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use. - 2. Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs. - 3. Non-clinical performance testing must demonstrate the ability of the device to detect adequate PPG signal quality. - 4. Human factors and usability testing must demonstrate the following: - The user can correctly use the device based solely on reading the device labeling; a. and - b. The user can correctly interpret the device output and understand when to seek medical care. - 5. Labeling must include: - a. Hardware platform and operating system requirements; - b. Situations in which the device may not operate at an expected performance level; - A summary of the clinical performance testing conducted with the device: C. - d. A description of what the device measures and outputs to the user; and - Guidance on interpretation of any results. e.

In combination with the general controls of the FD&C Act, the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate and/or respiratory rate is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use. (2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs. (3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality. (4) Human factors and usability testing must demonstrate the following: (i) The user can correctly use the device based solely on reading the device labeling; and (ii) The user can correctly interpret the device output and understand when to seek medical care. (5) Labeling must include: (i) Hardware platform and operating system requirements; (ii) Situations in which the device may not operate at an expected performance level; (iii) A summary of the clinical performance testing conducted with the device; (iv) A description of what the device measures and outputs to the user; and (v) Guidance on interpretation of any results.

Predicate Devices

Irregular Rhythm Notification Feature (DEN180042)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 26, 2021 Apple Inc. Luke Olson Regulatory Affairs Associate 1 Apple Park Way Cupertino, California 95014 Re: K212516 Trade/Device Name: IRNF App Regulation Number: 21 CFR 870.2790 Regulation Name: Photoplethysmograph analysis software for over-the-counter use Regulatory Class: Class II Product Code: QDB Dear Luke Olson: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 22, 2021. Specifically, FDA is updating this SE Letter due to a typo in the trade name as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih Kozen, Office of Cardiovascular Devices, 301-796-5813, Jennifer.Shih(@fda.hhs.gov. Sincerely, # Jennifer W. Shih -S Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION". October 22, 2021 Apple Inc. Luke Olson Regulatory Affairs Associate 1 Apple Park Way Cupertino, California 95014 Re: K212516 Trade/Device Name: Irregular Ryhthm Notification Feature (IRNF) 2.0 App Regulation Number: 21 CFR 870.2790 Regulation Name: Photoplethysmograph analysis software for over-the-counter use Regulatory Class: Class II Product Code: QDB Dated: August 9, 2021 Received: August 10, 2021 Dear Luke Olson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {2}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Jennifer W. Shih -S Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212516 Device Name Irregular Rhythm Notification Feature 2.0 #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | | |----------------------------------------------|---------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | X | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: ### 5.1 Submitter | Applicant | Apple Inc. One Apple Park Way Cupertino, CA 95014 | |----------------------------|--------------------------------------------------------------------------------------------| | Primary Correspondent | Luke Olson Regulatory Affairs Phone: (408) 609-2001 Email: luke_olson@apple.com | | Secondary Correspondent | Dachan Kwon Regulatory Affairs Phone: (669) 268-5659 Email: dachan_kwon@apple.com | | Date Prepared | August 09, 2021 | ## 5.2 Device Names and Classifications #### Subject Device: | Name of Device | Irregular Rhythm Notification Feature 2.0 | |------------------------|------------------------------------------------------------------------------------| | Classification Name | Photoplethysmograph Analysis Software For Over-The-Counter Use, 21 CFR 870.2790 | | Regulatory Class | Class II | | Product Code | QDB | | 510(k) Review Panel | Cardiovascular | ### Predicate Device: | Predicate Manufacturer | Apple Inc. | |---------------------------|---------------------------------------| | Predicate Trade Name | Irregular Rhythm Notification Feature | | Predicate 510(k) | DEN180042 | {5}------------------------------------------------ ## 5.3 Device Description 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. ## 5.4 Indications for Use The Irreqular 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. {6}------------------------------------------------ ## 5.5 Comparison with the Predicate Device | Item | Subject Device | Predicate Device | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | IRNF 2.0 App (K212516) | IRNF App (DEN180042) | | Manufacturer | Apple Inc. | Apple Inc. | | Submission Reference | K212516 | DEN180042 | | Intended Use | Photoplethysmograph analysis software for over-the-counter use. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis. | Photoplethysmograph analysis software for over-the-counter use. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis. | | | Subject Device | Predicate Device | | ltem | IRNF 2.0 App (K212516) | IRNF App (DEN180042) | | Indications for Use | 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 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 | | Principle of Operation | The IRN 2.0 acquires platform sensor data from Apple Watch. After acquisition, the IRN 2.0 algorithms analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides notification to the user. | The IRN app acquires platform sensor data from Apple Watch. After acquisition, the IRN app algorithms analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides notification to the user. | | Item | Subject Device | Predicate Device | | | IRNF 2.0 App (K212516) | IRNF App (DEN180042) | | Clinical Performance | Apple conducted a clinical validation study to assess the performance of the subject IRNF 2.0 app relative to that of the predicate device on a common sensor dataset. IRNF 2.0 person-level sensitivity (88.6%) and specificity (99.3%) were both demonstrated to be non-inferior to those of the predicate device. | In a study of 226 participants aged 22 years or older wearing Apple Watch and an electrocardiogram (ECG) patch concurrently, 57 participants received AFib notifications. Of those, 78.9% (45/57) showed concordant AFib on the ECG patch, while 98.2 % (56/57) showed AFib and other clinically relevant arrhythmias. | | Compatibility with Intended Platforms | iOS version 15.5 or later watchOS version 8.5 or later Apple Watch Series 3, 4, 5, SE iPhone 6s and later | iOS 12.1.1 and later watchOS 5.1.2 and later Apple Watch Series 1 and later iPhone 5s and later | {7}------------------------------------------------ {8}------------------------------------------------ ## 5.6 Performance Testing IRNF 2.0 was verified and validated according to Apple's internal design control processes and in accordance with the special controls for Photoplethysmograph Analysis software for over-the-counter use (21 CFR 870.2790). The testing demonstrated that the device performed according to its specifications and that the technological and performance criteria are comparable to the predicate device. IRNF 2.0 includes a new rhythm classification algorithm that leverages machine learning techniques to differentiate between AFib and non-AFib rhythms. The new rhythm classification algorithm uses a convolutional neural network based architecture and was trained extensively using data collected in a number of development studies. In total, the studies included over 2500 subjects and collected over 3 million pulse rate recordings on a variety of rhythms including: atrial fibrillation, normal sinus rhythm, sinus arrhythmia, and other ectopic beats (PVCs, PACs). {9}------------------------------------------------ The studies used to train the convolutional network recruited demographically diverse populations with broad representation of age, sex, BMI, race, and skin tones. Table 2 below summarizes approximate development study demographic characteristics: | Age Group (years) | | |---------------------------|-------| | <55 | 39.5% | | >=55 to <65 | 25.4% | | >=65 | 35.1% | | Sex | | | Male | 49.6% | | Female | 50.4% | | BMI (kg/m2) | | | <18.5 | 2.2% | | >=18.5 to <25.0 | 32.7% | | >=25.0 to <30.0 | 32.2% | | >=30.0 | 32.9% | | Race | | | White | 71.5% | | Black or African American | 18.0% | | Other | 10.5% | ## Table 2. Development Study Subject Demographics For the purpose of developing the algorithm, the data was split into four sets with matching distributions of rhythms and demographics: Traininq, Validation, Testing, and Sequestration sets. The model was trained on the Training set, with the Validation set used for early stopping and threshold selection. The model was then evaluated on the Testing set at reqular intervals during model development. When development was complete the model was locked, and then evaluated on the Sequestration set as a last test to ensure it had not been over-fit to the development data. {10}------------------------------------------------ ## 5.7 Clinical Performance The performance of the Irreqular Rhythm Notification Feature (IRNF) was extensively tested in a clinical study of 573 participants ages 22 and older with a mix of diagnosed AFib and no known history of AFib. Study demographic characteristics are summarized in Table 3 below: | | N=573 | |---------------------------|-------------| | Age Group (years) | | | <55 | 123 (21.5%) | | >=55 to <65 | 140 (24.4%) | | >=65 | 310 (54.1%) | | Sex | | | Male | 286 (49.9%) | | Female | 287 (50.1%) | | Ethnicity | | | Hispanic or Latino | 38 (6.6%) | | Non-Hispanic or Latino | 535 (93.4%) | | Race | | | White | 502 (87.6%) | | Black or African American | 57 (9.9%) | | Other | 14 (2.4%) | ## Table 3. IRNF 2.0 Clinical Study Subject Demographics Enrolled subjects wore an Apple Watch and a reference electrocardiogram (ECG) patch concurrently for up to 13 days. For those subjects contributing data to the primary endpoint analysis, 32.4% (n=140/432) presented with AFib as identified on the reference ECG patch and were included in determining the device sensitivity. Of those, 124 received an IRNF irregular rhythm notification with concordant AFib on the ECG patch, and the sensitivity was 88.6%. Of the 292 subjects who did not present with AFib on the ECG patch and contributed data to the analysis of device specificity, 290 did not receive a notification. The AF detection specificity was 99.3%. The remaining subjects (n=141/573) either contributed data to only secondary endpoint analyses and/or did not complete the study. These results support the device's effectiveness in detecting AFib. {11}------------------------------------------------ ## 5.8 Human Factors Testing Compared to the predicate device, there is no change to the indications for use, intended user populations, intended part of body applied to, use environment, operating principle, user interactions, use related hazards, use scenarios and critical tasks for IRNF 2.0. As such, Apple leveraged the Usability Engineering Report generated during development of the predicate device. ## 5.9 Conclusion IRNF 2.0 is substantially equivalent to IRNF as they are identical with respect to intended use and there are no differences in technological or performance characteristics that raise new questions of safety and effectiveness.

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