The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals.

Device Description

The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) single-lead ECG (electrocardiogram) event recorders. The device utilizes the processing power of a mobile computing platform (MCP) while reducing the complexity of the electronics hardware associated with data acquisition and transmission. The device is placed on the chest or held by the user's hands to provide a single-channel ECG rhythm strip. Similar to other mobile ECG devices, the AliveCor Heart Monitor uses a proprietary method of data transmission using acoustic waves to communicate with the MCP where the waveform is stored, displayed, and analyzed for the presence of atrial fibrillation.

AI/ML Overview

The provided text describes the AliveCor Heart Monitor and its 510(k) premarket notification (K140933) to the FDA. The submission focuses on establishing substantial equivalence to predicate devices, particularly regarding its ability to record, store, transfer, and display single-channel ECG rhythms, and detect the presence of atrial fibrillation (AF).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly provide a table of acceptance criteria with specific quantitative thresholds. However, it states that "The AF algorithm was tested in accordance with AAMI/ANSI EC57" and that "The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use."

Based on the context, the primary performance criterion for the atrial fibrillation (AF) algorithm is its ability to accurately detect AF. While a table isn't present, the implied acceptance criterion is adherence to AAMI/ANSI EC57 standards for AF algorithm validation. The reported device performance is that it meets these established specifications.

Implied Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Atrial Fibrillation (AF) Detection Algorithm	Adherence to AAMI/ANSI EC57 standards for AF algorithm validation.	The AF algorithm was tested in accordance with AAMI/ANSI EC57, and the collective results demonstrate it meets the established specifications.
ECG Recording, Storage, and Transfer	Consistent performance for intended use.	Non-clinical testing results demonstrate that the device meets established specifications for consistent performance for its intended use.

Study Details Proving Acceptance Criteria

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "ECGs that were previously recorded using the AliveCor Heart Monitor." It doesn't specify the number of ECGs used for validation.
- Data Provenance: The data used for validation consisted of "ECGs that were previously recorded using the AliveCor Heart Monitor." The country of origin is not specified, but it implies a dataset collected by AliveCor itself. The data is retrospective, as it refers to "previously recorded" ECGs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The text mentions "labeled by cardiologists," implying multiple cardiologists, but the exact number is not provided.
- Qualifications of Experts: "Cardiologists." No specific experience level (e.g., "10 years of experience") is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated. The text only says the ECGs were "labeled by cardiologists." The specific method of reconciliation or consensus among cardiologists (if multiple were involved) is not described.
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:
- No, an MRMC comparative effectiveness study was not done. The text focuses on the standalone algorithm's performance against expert-labeled ground truth, not on human-AI collaboration or improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone algorithm performance study was done. The text explicitly states, "The AF algorithm was tested in accordance with AAMI/ANSI EC57. ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm." This describes a standalone validation of the algorithm against a ground truth without human-in-the-loop interaction for the validation phase. The device itself is intended for use by individuals and can detect AF, implying a standalone detection capability.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was expert consensus/labeling by cardiologists. The text mentions "ECGs... labeled by cardiologists."
The sample size for the training set:
- Not stated. The document refers to "ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm." It does not provide information about a separate training set size. It is possible the validation dataset was also used in some capacity for development or refinement, or the details of the training set are outside the scope of what was provided in this 510(k) summary.
How the ground truth for the training set was established:
- Not stated, as the training set details are not provided in the document.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15, 2014

Alivecor, Inc. Albert Boniske Director of Regulatory Affairs 30 Maiden Lane, 6th Floor San Francisco, California 94108

Re: K140933

Trade/Device Name: Alivecor Heart Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and Receivers, Electrocardiograph, Telephone Regulatory Class: Class II Product Code: DXH, DPS Dated: July 9, 2014 Received: July 10, 2014

Dear Albert Boniske.

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. 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image contains the logo for AliveCor. The logo consists of a blue geometric shape resembling a cube with a heart-like shape inside, followed by the text "AliveCor" in a bold, sans-serif font. The logo is clean and modern, suggesting a focus on technology and health.

SECTION 4 INDICATIONS FOR USE STATEMENT

K140933 510(k) Number:

AliveCor Heart Monitor Device Names:

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the AliveCor logo. The logo consists of a blue geometric shape on the left and the word "AliveCor" in black on the right. The geometric shape is made up of lines that form a cube-like structure. The word "AliveCor" is written in a sans-serif font, and the letters are connected to each other.

SECTION 5

510(k) SUMMARY

510(k) Notification K140933

General Information

Applicant: AliveCor, Inc. 30 Maiden Lane, 6th Floor San Francisco, CA 94108

Contact Person: Albert Boniske Director of Regulatory Affairs AliveCor, Inc. Phone: 415-795-9811 Fax: 415-397-0440

Date Prepared: April 9, 2014

Device Information

Trade Name: AliveCor Heart Monitor

Generic/Common Name: Electrocardiograph

Classification: 21 CFR§870.2340, Electrocardiograph, Class II

Product Code:

DPS, DXH

PREDICATE DEVICE(S)

. K130921 – AliveCor Heart Monitor
K052767 AfibAlert ●
K122184 ECG Check .

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Image /page/4/Picture/0 description: The image shows the AliveCor logo. The logo consists of a blue geometric shape on the left and the word "AliveCor" in black on the right. The geometric shape is a stylized cube with an "M" shape inside. The word "AliveCor" is written in a sans-serif font, with the "TM" symbol in superscript after the "r".

INDICATIONS FOR US

Device Description

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the AliveCor Heart Monitor. The AliveCor Heart Monitor operates using the same technological characteristics for the same intended use as its predicate devices record and store ECGs and indicate the presence of abnormalities in the recording. The nonclinical testing results demonstrate that any differences in the technological characteristics between the subject and predicate devices do not raise any new issues of safety or effectiveness. Thus, the AliveCor Heart Monitor is substantially equivalent to the predicate devices.

Nonclinical Testing in Support of Substantial Equivalence Determination

All necessary performance testing was conducted on the AliveCor Heart Monitor to support a determination of substantial equivalence to the predicate devices. The non-clinical testing included software verification and atrial fibrillation (AF) algorithm validation. The AF algorithm was tested in accordance with AAMI/ANSI EC57. ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm. The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use.

CONCLUSION

The results of the nonclinical testing demonstrate that the AliveCor Heart Monitor is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).