KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.

The KardiaAI library provides the following capabilities:

Filtering ECG noise,
Reporting heart rate measurement from ECGs,
Detecting noisy ECGs.
Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, for ECGs detected as sinus rhythm, detecting normal sinus rhythm with with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy;
Detecting QRS complexes in an ECG.
For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and
Generating an average beat from an ECG

The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

Device Description

KardiaAI is a software library that implements various ECG processing and analysis algorithms. This Software as a Medical Device (SaMD) computes various physiologic parameters from an ECG and provides these capabilities in the form of an Application Program Interface (API) library. AliveCor-designed ECG devices ("target device") incorporate the API library into their device software to enable algorithmic analysis of ECGs to provide analytical capabilities. KardiaAI provides ECG processing functions, including ECG noise filtering and detection of noisy ECGs. It performs rhythm analysis on ECGs, specifically detecting atrial fibrillation, bradycardia, tachycardia and sinus rhythm, which can be further classified as normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with supraventricular ectopy. It further provides beat-level annotations, including beat-level ORS locations, and, for sinus rhythm ECGs, PVC/not-PVC annotations. It also provides an average beat ECG representation, and the R-R interval tachogram. Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices (i.e., the target devices) into which the API library is incorporated, such as AliveCor's Triangle System (K183319) and KardiaMobile System (K182396).

AI/ML Overview

The provided text describes the KardiaAI, a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms. The information regarding acceptance criteria and the study proving the device meets these criteria is fragmented across different sections.

Here's an organized breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document states that "All analysis outputs were found to meet their performance specifications" and "it was found that the subject device demonstrated equivalent performance to the predicate device." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and their corresponding reported device performance values are not explicitly detailed in the provided text. The table below represents the types of performance claimed to be met, but the precise numerical targets and outcomes are absent.

Acceptance Criteria Category	Reported Device Performance
Algorithm performance	Met specifications; equivalent to predicate device
Software function	Performs as intended
Human factors/Usability	Users can use the device and understand outputs based on labeling, and understand appropriate actions

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions an "AliveCor proprietary ECG database" and "databases from the ANSVAAMI EC57" were used for algorithm performance testing. No specific number of ECGs or patients is given for either database.
Data Provenance:
- AliveCor proprietary ECG database: No information on country of origin.
- ANSVAAMI EC57 databases: No information on country of origin.
- Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The method for establishing ground truth is mentioned as "AliveCor proprietary ECG database" and "databases from the ANSVAAMI EC57", but details on expert involvement and qualifications are missing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study focused on human readers improving with AI assistance was not described in the provided text. The document refers to "comparative testing" between the subject device and the predicate device's algorithm performance, but this is a comparison of algorithms, not human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone algorithm-only performance study was conducted. The "Nonclinical Testing Summary" states: "Specifically, algorithm performance testing was assessed using an AliveCor proprietary ECG database. Additional comparative testing was also performed on databases from the ANSVAAMI EC57. All analysis outputs were found to meet their performance specifications." This indicates testing of the algorithm's performance independent of human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the specific type of ground truth used. It mentions using an "AliveCor proprietary ECG database" and "databases from the ANSVAAMI EC57" for algorithm performance testing. This implies that these databases contained pre-established "ground truth" annotations for the ECGs, but the method by which that ground truth was established (e.g., expert interpretation, comparison to other diagnostic tests) is not detailed.

8. The sample size for the training set

The document does not provide the sample size for the training set. It only mentions the databases used for "algorithm performance testing," which typically refers to evaluation on a test set, distinct from a training set.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established, nor does it explicitly mention details about a training set.

Summary

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November 12, 2020

AliveCor, Inc. % Prabhu Raghavan Principal MDQR, LLC 444 Castro Street, Suite 600 Mountain View. California 94041

Re: K201985

Trade/Device Name: KardiaAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: October 12, 2020 Received: October 13, 2020

Dear Prabhu Raghavan:

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

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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,

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

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Indications for Use

510(k) Number (if known) K201985

Device Name

KardiaAI

Indications for Use (Describe)

The KardiaAl library provides the following capabilities:

· Filtering ECG noise,
· Reporting heart rate measurement from ECGs,
· Detecting noisy ECGs.

· Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, for ECGs detected as sinus rhythm, detecting normal sinus rhythm with with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy;

· Detecting QRS complexes in an ECG.

· For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and
· Generating an average beat from an ECG

The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

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)

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510(k) Summary for K201985

Prepared in accordance with the requirements of 21 CFR 807.92

Submitter Information [807.92(a)(1)]

Submitter/Applicant	AliveCor, Inc.444 Castro Street, Suite 600Mountain View, CA 94041Phone: 650-396-8553Fax: 650-282-7932
Primary Contact Person	Prabhu RaghavanRegulatory Consultant for AliveCorMDQR, LLC444 Castro Street, Suite 600Mountain View, CA 94041Phone: 408-316-5707Fax: 650-282-7932Email: prabhu@mdqr.solutions
Submitter andSecondary Contact Person	Saket BhattVP of Regulatory and Quality444 Castro Street, Suite 600Mountain View, CA 94041Phone: 408-701-7319Fax: 650-282-7932Email: ra@alivecor.com

Date Prepared

July 15, 2020

Device Information [807.92(a)(2)]

Trade Name	KardiaAI
Common Name	Programmable diagnostic computer
Classification	21 CFR§870.1425
Device Class	Class II
Product Code	DQK
Subsequent Product Code	DPS

Predicate Information [807.92(a)(3)]

Predicate(s)

AliveCor, Inc., KardiaAI, K181823

Device Description [807.92(a)(4)]

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510(k) Summary for KardiaAI AliveCor, Inc.

library. AliveCor-designed ECG devices ("target device") incorporate the API library into their device software to enable algorithmic analysis of ECGs to provide analytical capabilities. KardiaAI provides ECG processing functions, including ECG noise filtering and detection of noisy ECGs. It performs rhythm analysis on ECGs, specifically detecting atrial fibrillation, bradycardia, tachycardia and sinus rhythm, which can be further classified as normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVCs), and sinus rhythm with supraventricular ectopy. It further provides beat-level annotations, including beat-level ORS locations, and, for sinus rhythm ECGs, PVC/not-PVC annotations. It also provides an average beat ECG representation, and the R-R interval tachogram. Recording and viewing of ECGs and the results of the KardiaAI analyses are to be provided by other AliveCor FDA-cleared devices (i.e., the target devices) into which the API library is incorporated, such as AliveCor's Triangle System (K183319) and KardiaMobile System (K182396).

Indications for use [807.92(a)(5)]

The KardiaAI library provides the following capabilities:

Filtering ECG noise.
Reporting heart rate measurement from ECGs, ●
o Detecting noisy ECGs,
Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, ● bradycardia, and tachycardia; for ECGs detected as sinus rhythm, detecting normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy,
Detecting QRS complexes in an ECG,
For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC ● beat, and
o Generating an average beat from an ECG

The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.

Substantial Equivalence

The subject device has the same intended use as the predicate devices intended are to process (e.g., filter and detect noise) and analyze a single channel ECG signal to detect the presence of arrhythmias. These ECG analysis outputs from the subject and predicate device all represent potential findings to be reviewed and interpreted by a qualified healthcare professional, and do not represent complete diagnoses. Both devices are software-only API libraries and are intended to be incorporated into other Alive Cor-designed medical devices ("target device"). Both the subject and predicate device process and analyze recorded ECGs, the output of which are stored, transferred, and displayed by the target device.

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The subject device includes all the software outputs of the predicate device with updates in algorithm design and provides several new analysis outputs which are within the general intended use shared with the predicate device. Like the predicate device, the subject device's ECG analysis functionalities with respect to arrhythmia detection are prescription features.

As such, the subject device has the same intended use and technological characteristics as the predicate device. Differences between the subject device and the predicate device do not raise different questions of safety or effectiveness from the predicate device, and performance testing has demonstrated that the subject device meets its performance specifications and is as safe and as effective as the predicate device for their intended use. Therefore, KardiaAI is substantially equivalent to the predicate device.

Feature	AliveCor KardiaAI(Subject Device)	AliveCor KardiaAI (K181823)(Predicate Device)
Product Code	DQK, Computer, Diagnostic,Programmable	DQK, Computer, Diagnostic,Programmable
	DPS, Electrocardiograph	DPS, Electrocardiograph
Regulation	21 CFR§870.1425, Programmablediagnostic computer	21 CFR§870.1425, Programmablediagnostic computer
	Class II	Class II
Feature	AliveCor KardiaAI(Subject Device)	AliveCor KardiaAI (K181823)(Predicate Device)
Indications foruse	KardiaAI is a software analysis libraryintended to assess ambulatoryelectrocardiogram (ECG) rhythms fromadult subjects (when prescribed or usedunder the care of a physician). Thedevice supports analyzing data recordedin compatible formats from anyambulatory ECG devices such as eventrecorders, or other similar devices. Thelibrary is intended to be integrated intoother device software. The library is notintended for use in life supporting, orsustaining systems, or ECG monitors, orcardiac alarm, or OTC use only devices.The KardiaAI library provides thefollowing capabilities:• Filtering ECG noise,• Reporting heart rate measurementfrom ECGs,• Detecting noisy ECGs,• Reporting ECG rhythm analysis forthe presence of sinus rhythm, atrialfibrillation, bradycardia, andtachycardia; for ECGs detected assinus rhythm, detecting normal sinusrhythm, sinus rhythm with wideQRS, sinus rhythm with prematureventricular contractions (PVC), andsinus rhythm with supraventricularectopy,• Detecting QRS complexes in anECG,• For ECGs detected as sinus rhythm,classifying individual beats as a PVCor non-PVC beat, and• Generating an average beat from anECGThe device is not intended for use inpatients who have pacemakers, ICDs, orother implanted electronic devices	KardiaAI is a software analysis libraryintended to assess ambulatoryelectrocardiogram (ECG) rhythms fromadult subjects.The device supports analyzing datarecorded in compatible formats fromany ambulatory ECG devices such asevent recorders, or other similar devices.The library is intended to be integratedinto other device software.The library is not intended for use in lifesupporting, or sustaining systems, orECG monitors, or cardiac alarm, orOTC use only devices.KardiaAI provides the followingcapabilities:• ECG noise filtering,• heart rate measurement from ECGs,• detection of noisy ECGs, and• ECG rhythm analysis for detectingthe presence of normal sinus rhythm,atrial fibrillation, bradycardia, andtachycardia (when prescribed or usedunder the care of a physician).
Targetpopulation	Adults (over 18)	Adults (over 18)
Components	Software only	Software only
Feature	AliveCor KardiaAI(Subject Device)	AliveCor KardiaAI (K181823)(Predicate Device)
SoftwareFunctionalities	An interface that provides tools toprocess and analyze ECGs throughvarious algorithms The automated proprietary ECGalgorithms provide supportiveinformation for ECG diagnosis. Thelibrary can be accessed by directlyconnecting to the KardiaAI'sApplication Programming Interface	An interface that provides tools toprocess and analyze ECGs throughvarious algorithms The automated proprietary ECGalgorithms provide supportiveinformation for ECG diagnosis. Thelibrary can be accessed by directlyconnecting to the KardiaAI'sApplication Programming Interface
CompatibleECG Devices	Triangle System (K183319) KardiaMobile System (K182396) Omron Model BP7900 BloodPressure Monitor + EKG (K182579)	Triangle System (K183319) KardiaMobile System (K182396) KardiaBand System (K171816) Omron Model BP7900 BloodPressure Monitor + EKG (K182579)

Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

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Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

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Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]

Performance Data [807.92(b)]

All necessary testing was conducted on KardiaAI to support a determination of substantial equivalence to the predicate device.

Nonclinical Testing Summary [807.92(b)(1)]

Nonclinical testing, similar to that conducted to support the predicate device, was conducted to assess algorithm performance and to verify that KardiaAI performs as intended.

Software testing was conducted for KardiaAI. Specifically, algorithm performance testing was assessed using an AliveCor proprietary ECG database. Additional comparative testing was also performed on databases from the ANSVAAMI EC57. All analysis outputs were found to meet their performance specifications. Specifically, for the algorithm outputs which are present in both KardiaAI and the predicate device, comparative testing was conducted, and it was found that the subject device demonstrated equivalent performance to the predicate device. The results of the testing demonstrate that KardiaAI performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.

In addition, a human factors usability study was conducted in accordance with recommendations in IEC 62366-1:2015, "Medical devices - Part 1: Application of usability engineering to medical devices", and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. The results of the study demonstrated that users can use the device and understands its outputs based on labeling, and further understand appropriate actions if symptoms are present, such as when to seek medical care.

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510(k) Summary for KardiaAI AliveCor, Inc.

Conclusions [807.92(b)(3)]

KardiaAI has the same intended use as the predicate device, and any differences in technological characteristics do not raise different questions of safety or effectiveness. Differences between the subject device and the predicate device have been tested to ensure that the device meets its intended use. The results of nonclinical testing specifically demonstrate that KardiaAI meets its intended use which is equivalent to that of the predicate device. Therefore, KardiaAI is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).