(95 days)
Not Found
Unknown
The document mentions "rhythm classification" and "algorithm detection of AFib and SR," which could potentially utilize AI/ML, but it does not explicitly state the use of these technologies. The lack of information on training sets and annotation protocols also makes it difficult to confirm.
No
Explanation: The device is intended for informational use only and is not intended to replace traditional methods of diagnosis or treatment, nor is it for users with other known arrhythmias. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Yes
The device's intended use explicitly states its purpose is to create, record, store, transfer, and display a single channel ECG for informational use, with classifiable traces labeled as atrial fibrillation (AFib) or sinus rhythm to aid heart rhythm identification. This process of identifying and labeling potential conditions from physiological signals falls under diagnostic applications, even though it's not intended to replace traditional methods of diagnosis.
No
While the intended use states "software-only", the device description explicitly mentions the "compatible Samsung wearable application captures bioelectrical signals from the user and generates single lead ECG signals". This indicates a hardware component (the wearable) is essential for data acquisition, making it more than just software. Additionally, the performance studies include "Platform Interface HW Testing", further confirming the involvement of hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Device Function: The Samsung ECG Monitor Application directly measures bioelectrical signals from the user's body (in vivo) through contact with the skin on the wrist. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to record and display a single channel ECG for informational use and to aid in heart rhythm identification (AFib or sinus rhythm). This is a direct measurement of a physiological signal, not an analysis of a biological specimen.
Therefore, the Samsung ECG Monitor Application falls under the category of a medical device that performs a direct physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Product codes
ODA
Device Description
The Samsung ECG Monitor Application consists of a pair of mobile medical apps: one on a compatible Samsung wearable and the other on a compatible Samsung phone. The compatible Samsung wearable application captures bioelectrical signals from the user and generates single lead ECG signals, calculates average heart rate and classifies the rhythm. The wearable application securely transmits the obtained data to the phone application on the paired phone device. The phone application shows the ECG measurement history and generates the PDF file for the received ECG signals which can be shared by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults 22 years and older
Intended User / Care Setting
over-the-counter (OTC)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following clinical, usability, and bench testing was conducted with the Samsung Galaxy Watch Active2, showing the SaMD meets predetermined acceptance criteria to demonstrate safety, effectiveness, and substantial equivalence to the previously cleared Apple ECG App device. No new safety issues were found during this testing.
- Clinical validation showing non-inferiority to the predicate in clinical performance in terms of
- ECG signal quality sufficiency
- Rhythm classification accuracy
- Human Factors Validation
- IEC 60601-2-47 ECG Database Testing
- Heart Rate Accuracy Bench Testing
- SW Verification Testing
In addition, testing was performed on the platforms, showing they meets all necessary specifications to safely and effectively host the subject SaMD. This included the following:
- ECG Signal Quality and Lead Detection Bench Testing
- Platform Interface SW Testing (for both platforms)
- Platform Interface HW Testing
- General safety tests: Electrical safety, electromagnetic compatibility, radio frequency emissions, material safety for skin contact, thermal safety for skin contact tests
- Device robustness tests: Resistance to electrostatic discharge, water ingress and breakage tests
Clinical Study:
The study enrolled 544 subjects, among whom 268 were AFib patients, 261 had sinus rhythm (SR), and 15 had other arrhythmias. The ECG App algorithm detection of AFib and SR was compared to cardiologists' read of 12-lead ECG reference strip.
To assess the signal quality of the ECG Monitor App recording, cardiologists' interpretation of the ECG Monitor App strips was compared to the paired reference 12-lead ECG.
To further assess the ECG waveform accuracy, a total of 140 subjects (AFib cohort: 70, SR cohort: 70) were randomly selected for fiducial point annotation. Three blinded, independent ECG technicians marked the fiducial points for key ECG features (QRS amplitude, RR interval, QRS duration, PR interval) in comparison between the ECG Monitor App strip and the reference 12-lead ECG.
Key Metrics
Among the recordings where the algorithm output a rhythm classification, AFib was correctly indicated with 98.1% sensitivity (95%CI: 96.3%, 99.9%) and 100% specificity (95% CI: 100%) in the Samsung ECG Monitor App, while the predicate showed 99.6% sensitivity (95% CI: 98.7%, 100%) and 99.6% specificity (95% CI: 98.8%, 100%) in the comparison study. As a result, the sensitivity and specificity of the Samsung ECG Monitor App were within the pre-determined non-inferiority margin, thus the primary endpoint was met.
The ratio of readings that were deemed inconclusive (or unclassifiable) by the Samsung ECG Monitor App when the truth was either AFib or SR was 2.9% (95% CI: 1.1%, 4.7%) while the predicate was 2.2% (95% CI: 0.7%, 3.7%), which met the non-inferiority margin.
Cardiologists were able to interpret 98.5% (95% CI: 97.4%, 99.5%) of ECG recordings on the Samsung ECG Monitor App and 99.4% (95% CI: 98.8%, 100%) on the predicate App. The results showed good concordance between the interpretation of the ECG Monitor App strip and the reference 12-lead ECG, 99.4% (95%CI: 98.7%, 100%) on Samsung ECG Monitor App and 99.8% (95%CI: 99.4%, 100%) on the predicate ECG App. Both of the interpretation and agreement met the pre-determined non-inferiority margin.
Predicate Device(s)
Apple ECG App (DEN180044)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2345 Electrocardiograph software for over-the-counter use.
(a)
Identification. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must demonstrate the following:
(i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and
(ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.
(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 validate detection algorithm performance using a previously adjudicated data set.
(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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 4, 2020
Samsung Electronics Co., Ltd Matthew Wiggins, Ph.D. Director, Medical Device Team 665 Clyde Avenue Mountain View. California 94043
Re: K201168
Trade/Device Name: Samsung ECG Monitor Application Regulation Number: 21 CFR 870.2345 Regulation Name: Electrocardiograph software for over-the-counter use Regulatory Class: Class II Product Code: ODA Dated: July 14, 2020 Received: July 15, 2020
Dear Matthew Wiggins:
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 may, 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih 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
2
Indications for Use
510(k) Number (if known) K201168
Device Name Samsung ECG Monitor Application
Indications for Use (Describe)
The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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."
3
Samsung ECG Monitor Application 510(k) Summary
Applicant Information
| Manufacturer: | Samsung Electronics Co., Ltd
129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16677, Korea |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Matthew Wiggins, Ph.D.
Samsung Research America
665 Clyde Avenue, Mountain View, CA 94043
770-596-1765
m.wiggins@samsung.com |
| Date Prepared: | August 4th, 2020 |
Device Information
| Proprietary Name: | Samsung ECG Monitor Application |
|---|---|
| Common Name: | ECG Monitor App |
| Classification: | QDA - Electrocardiograph software for over-the-counter use (21 CFR 870.2345) |
| Predicate Device: | Apple ECG App (DEN180044) |
Device Description
The Samsung ECG Monitor Application consists of a pair of mobile medical apps: one on a compatible Samsung wearable and the other on a compatible Samsung phone. The compatible Samsung wearable application captures bioelectrical signals from the user and generates single lead ECG signals, calculates average heart rate and classifies the rhythm. The wearable application securely transmits the obtained data to the phone application on the paired phone device. The phone application shows the ECG measurement history and generates the PDF file for the received ECG signals which can be shared by the user.
Intended Use/Indications for Use
The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
4
Comparison of Technological Characteristics
- The predicate and the subject device have an equivalent intended use, ●
- The operating principle and specifications are equivalent, and ●
- Clinical and Usability validation testing, as well as bench testing, show performance equivalence . and bring up no new safety or effectiveness questions.
A more detailed comparison of the devices is provided below in Table 1.
5
Table 1. Technological Comparison
| Specification | Predicate SaMD
Apple ECG App (DEN 180044) | Samsung ECG Monitor App | Difference |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 Samsung ECG Monitor Application is
an over-the-counter (OTC) software-only,
mobile medical application operating on a
compatible Samsung Galaxy Watch and
Phone. The app is intended to create,
record, store, transfer, and display a single
channel electrocardiogram (ECG), similar
to a Lead I ECG, for informational use only
in adults 22 years and older. Classifiable
traces are labeled by the app as either atrial
fibrillation (AFib) or sinus rhythm with the
intention of aiding heart rhythm
identification; it is not intended to replace
traditional methods of diagnosis or
treatment. The app is not intended for users
with other known arrhythmias and users
should not interpret or take clinical action
based on the device output without
consultation of a qualified healthcare
professional. | Equivalent |
| Patient population | Adults not previously diagnosed with
other known arrhythmias | Adults not previously diagnosed with
other known arrhythmias | Equivalent |
| Prescription Use/OTC | OTC | OTC | Equivalent |
| Lead | A single channel electrocardiogram
(ECG) similar to a Lead I ECG. | A single channel electrocardiogram
(ECG) similar to a Lead I ECG. | Equivalent |
| ECG duration | 30 seconds | 30 seconds | Equivalent |
| Rhythms detected | Atrial Fibrillation (HR between 50-120
BPM)
Sinus Rhythm (HR between 50-100 BPM)
Inconclusive (Any Other Rhythm and HR
120
BPM) OR (Not SR or AFib and HR 50-
100 BPM) OR (SR and HR >100 BPM) | Atrial Fibrillation (HR between 50-120
BPM)
Sinus rhythm (HR between 50-100 BPM)
Inconclusive (Any Other Rhythm and HR
120
BPM) OR (Not SR or AFib and HR 50-
100 BPM) OR (SR and HR >100 BPM) | Equivalent |
| Heart Rate | Yes | Yes | Equivalent |
| Key Platform Sensor | A single channel electrocardiogram
(ECG) similar to a Lead I ECG taken from
electrodes on the back of the watch on one
wrist and the digital crown where the
finger is placed | A single channel electrocardiogram
(ECG) similar to a Lead I ECG taken from
electrodes on the back of the watch on one
wrist and the top button where the
finger is placed | Placement of the finger
electrode on the top button of
the Samsung watch vs. the
predicate's digital crown. |
| Platforms | Wearable: Apple Watch with watch OS
Phone: Apple iPhones with iOS | Wearable: Samsung Galaxy Watch running
Tizen OS
Phone: Samsung Galaxy phones with
Android OS | Different hardware and OS for
both wearable and phone
platforms, both offering
similar communications and
sensor capabilities and
features. |
| User Interface | Apple watch screen for initiating spot
checks, viewing signal during
acquisition (user engagement feature,
not diagnosis quality), delivering
rhythm classification, and capturing
symptomsPhone screen for viewing and sharing
ECG spot check results, viewing | Samsung wearable screen for initiating
spot checks, viewing signal during
acquisition (user engagement feature,
not diagnosis quality), delivering
rhythm classification, and capturing
symptomsPhone screen for viewing and sharing
ECG spot check results, viewing | Equivalent |
| | historic data and PDF report including
recorded ECG and algorithmic rhythm
classification | historic data and PDF report including
recorded ECG and algorithmic rhythm
classification | |
| Algorithms | ECG Lead I Rhythm Classification for
Sinus Rhythm, Atrial Fibrillation,
Inconclusive (includes poor
recording), High/Low Heart Rate Heart Rate | ECG Lead I Rhythm Classification for
Sinus Rhythm, Atrial Fibrillation,
Inconclusive, Poor Recording (for low
quality or other reasons) Heart Rate | All rhythms classified are the
same as the predicate device
except:
Predicate device classifies
low signal quality as
Inconclusive- Poor
Recording while Samsung
classifies it as Poor
Recording. Predicate device has a
High/Low Heart Rate
classification, whereas
Samsung device outputs
Inconclusive in this case. Both devices provide Heart
Rate. |
| Rhythm Classification
Performance | Atrial Fibrillation Sensitivity: 98.3%
Sinus Rhythm Specificity: 99.6% | Atrial Fibrillation Sensitivity: 98.1%
Sinus Rhythm Specificity: 100% | Equivalent |
6
7
8
Performance Data
The following clinical, usability, and bench testing was conducted with the Samsung Galaxy Watch Active2, showing the SaMD meets predetermined acceptance criteria to demonstrate safety, effectiveness, and substantial equivalence to the previously cleared Apple ECG App device. No new safety issues were found during this testing.
- . Clinical validation showing non-inferiority to the predicate in clinical performance in terms of
- с ECG signal quality sufficiency
- Rhythm classification accuracy o
- Human Factors Validation ●
- IEC 60601-2-47 ECG Database Testing ●
- Heart Rate Accuracy Bench Testing
- SW Verification Testing .
In addition, testing was performed on the platforms, showing they meets all necessary specifications to safely and effectively host the subject SaMD. This included the following:
- ECG Signal Quality and Lead Detection Bench Testing ●
- Platform Interface SW Testing (for both platforms) ●
- . Platform Interface HW Testing
- General safety tests: Electrical safety, electromagnetic compatibility, radio frequency o emissions, material safety for skin contact, thermal safety for skin contact tests
- Device robustness tests: Resistance to electrostatic discharge, water ingress and breakage o tests
Clinical Study
The Samsung ECG Monitor App was proven to be non-inferior to the predicate in terms of rhythm classification accuracy and ECG signal quality sufficiency. No adverse events were observed.
The study enrolled 544 subjects, among whom 268 were AFib patients, 261 had sinus rhythm (SR), and 15 had other arrhythmias. The ECG App algorithm detection of AFib and SR was compared to cardiologists' read of 12-lead ECG reference strip. Among the recordings where the algorithm output a rhythm classification, AFib was correctly indicated with 98.1% sensitivity (95%CI: 96.3%, 99.9%) and 100% specificity (95% CI: 100%) in the Samsung ECG Monitor App, while the predicate showed 99.6% sensitivity (95% CI: 98.7%, 100%) and 99.6% specificity (95% CI: 98.8%, 100%) in the comparison study. As a result, the sensitivity and specificity of the Samsung ECG Monitor App were within the pre-determined non-inferiority margin, thus the primary endpoint was met.
The ratio of readings that were deemed inconclusive (or unclassifiable) by the Samsung ECG Monitor App when the truth was either AFib or SR was 2.9% (95% CI: 1.1%, 4.7%) while the predicate was 2.2% (95% CI: 0.7%, 3.7%), which met the non-inferiority margin.
To assess the signal quality of the ECG Monitor App recording, cardiologists' interpretation of the ECG Monitor App strips was compared to the paired reference 12-lead ECG. Cardiologists were able to interpret 98.5% (95% CI: 97.4%, 99.5%) of ECG recordings on the Samsung ECG Monitor App and 99.4% (95% CI: 98.8%, 100%) on the predicate App. The results showed good concordance between the interpretation of the ECG Monitor App strip and the reference 12-lead ECG, 99.4% (95%CI: 98.7%,
9
100%) on Samsung ECG Monitor App and 99.8% (95%CI: 99.4%, 100%) on the predicate ECG App. Both of the interpretation and agreement met the pre-determined non-inferiority margin.
To further assess the ECG waveform accuracy, a total of 140 subjects (AFib cohort: 70, SR cohort: 70) were randomly selected for fiducial point annotation. Three blinded, independent ECG technicians marked the fiducial points for key ECG features (QRS amplitude, RR interval, QRS duration, PR interval) in comparison between the ECG Monitor App strip and the reference 12-lead ECG. The key ECG features of Samsung ECG Monitor App were all within non-inferiority margin with statistical significance. Thus the secondary endpoints were met.
Conclusion
The Samsung ECG Monitor Application is substantially equivalent to the Apple ECG App (DEN180044). The devices have the same intended use, the same key technological characteristics, and the same signal acquisition capabilities. In a clinical testing, the Samsung ECG Monitor app demonstrated that it is noninferior to the predicate in quantitative ECG measurement and rhythm analysis accuracy.