The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

Device Description

The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the Frontier X Plus device. It does not contain a specific table of acceptance criteria with reported device performance results, nor does it detail a multi-reader, multi-case (MRMC) comparative effectiveness study or provide effect sizes for human readers with AI assistance.

However, based on the Clinical Testing Summary section on pages 10-11, we can infer information about the study design that proves the device meets certain performance criteria.

Here's an attempt to structure the available information per your request:

Acceptance Criteria and Device Performance Study

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes a clinical investigation designed to demonstrate "substantial equivalence" to a predicate device, focusing on the ability of the device's algorithm to accurately detect and classify ECG rhythms.

Inferred Acceptance Criteria & Reported Device Performance (Qualitative)

Acceptance Criteria (Inferred from Study Objectives)	Reported Device Performance (Qualitative from Summary)
Clinical equivalence of ECG waveforms to a simultaneously captured reference (12-lead ECG).	The study evaluated "comparative evaluation of the clinical equivalence of ECG waveforms recorded by the subject device to simultaneously captured ECG waveforms from a reference device (Standard 12-lead ECG)." The "Various quantitative and qualitative metrics including relevant ECG waveform characteristics were measured and analyzed. The data provided demonstrated the substantial equivalence with the predicate device."
Reliability of the algorithm to classify:	Assessed the "ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device." The "collective results of the performance testing demonstrate that the Frontier X Plus meets the established specifications and complies with the aforementioned standards."
- Atrial Fibrillation
- Normal Sinus Rhythm
- Tachycardia
- Inconclusive signals
- Noisy/Unreadable signals

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: A total of 832 users were included in the Study population for the clinical investigation.
- Data Provenance: The document does not specify the country of origin for the data. It seems to be a prospective study as it describes the conduct of a clinical investigation where ECGs "were collected and analyzed at various time points."
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document implies that the ground truth for the rhythm analysis (Atrial Fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive, noisy/unreadable signals) was established by comparison to a "standard 12-lead ECG device."
- It also states that the "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience." This suggests that physicians (likely cardiologists or electrophysiologists) were the experts, but the number of experts and their specific qualifications (e.g., years of experience) are not explicitly stated for ground truth establishment within the study.
Adjudication Method for the Test Set:
- The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set. It suggests that the 12-lead ECG served as the reference standard.
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, a MRMC comparative effectiveness study was not explicitly described or summarized in this document. The study focused on the device's (algorithm's) performance against a reference standard, not on how human readers' performance might improve with the device's assistance.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance evaluation of the algorithm appears to have been a primary component of the clinical investigation. The study "evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device." This describes the algorithm's performance independent of human readers.
The Type of Ground Truth Used:
- The primary ground truth used was simultaneously acquired signals from a standard 12-lead ECG device. This can be considered a form of clinical standard/reference data. The document also mentions that a "physician who will render a diagnosis based on clinical judgment and experience" reviews the reported information, implying physician interpretation as a ground truth for final diagnosis.
The Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set of the algorithm. It only discusses the clinical investigation/test set.
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, as it focuses on the validation study and not the algorithm development process.

Summary

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November 8, 2024

Fourth Frontier Technologies Pvt Ltd Manav Bhushan CEO 2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL, 2nd Stage, Indiranagar Bengaluru, Karnataka 560038 India

Re: K240794

Trade/Device Name: Frontier X Plus Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO. DXH. DPS Dated: November 7, 2024 Received: November 7, 2024

Dear Manav Bhushan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Jennifer W. Shih -S

Jennifer 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

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Indications for Use

510(k) Number (if known) K240794

Device Name Frontier X Plus

Indications for Use (Describe)

The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Notification K240794

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Fourth Frontier Technologies Private Limited 2nd and 3rd Floor, No. 794, 12th Main, 1st Cross, HAL 2ndStage Indiranagar, Bengaluru, 560038 Karnataka, India Phone: +1- 512-8817266

Applicant Contact Person:

Manav Bhushan CEO Fourth Frontier Technologies Private Limited

Email: manav@fourthfrontier.com

Date Prepared: November 4, 2024

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Frontier X Plus

Generic/Common Name:

Medical Magnetic Tape Recorder

Classification:

21 CFR§870.2800, Medical Magnetic Tape Recorder, Class II

Product Code:

MLO

Subsequent Product Code(s): DXH , DPS

PREDICATE DEVICE(S) [807.92(a)(3)]

K201644 - QardioCore ECG Monitor (primary predicate device) Product code: DSH

K182396 – AliveCor Heart Monitor (predicate device, currently marketed as "KardiaMobile") Product code: DXH, DPS

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DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician, who will render a diagnosis based on clinical judgment and experience.

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Comparison of Technological Characteristics with the predicate DEVICE[807.92(a)(6)]

Feature	Frontier X Plus	QardioCore ECG Monitor	KardiaMobile,KardiaStation System
510(k)	K240794	K201644	K182396
RegulationNumber(s)	21 CFR 870.2800	21 CFR 870.2800	21 CFR 870.292021 CFR 870.2340
RegulationName	● Medical MagneticTape Recorder	● Medical MagneticTape Recorder	● Transmitters AndReceivers,Electrocardiograph,TelephoneElectrocardiograph
RegulatoryClass	Class II	Class II	Class II
ClassificationProduct Code	MLO	DSH	DXH
SubsequentProductCode(s)	DXH, DPS	N/A	DPS
TheOverCounter	No	No	Yes
Indicationsforuse	The Frontier X Plusdevice is an ambulatorymonitoring deviceintended to record,store, and transfersingle-channel (ECG)rhythms for monitoringand evaluation. TheFrontier X Plus systemalso displays ECGwaveforms and ECGrhythm analysis;detecting the presenceof normal sinus rhythm	The QardioCore ECGambulatory monitoringdevice is intended tocapture, store, transmit,and display ECGinformation for recordingperiods of up to 24-hoursin a single session. It isindicated for use on adultpatients who may beasymptomatic or whomeet clinical indicationsto perform an ECG-Holtermonitor exam. TheQardioCore ECG monitoris a prescription only	The KardiaMobile System isintended to record, storeand transfer single-channelelectrocardiogram (ECG)rhythms. The KardiaMobilesystem also displays ECGrhythms and output of ECGanalysis from AliveCor'sKardiaAI platform includingdetecting the presence ofnormal sinus rhythm, atrialfibrillation, bradycardia,tachycardia, and otherswhen prescribed or usedunder the care of ahealthcare professional.
Feature	Frontier X Plus	QardioCore ECG Monitor	KardiaMobile,KardiaStation System
	atrial fibrillation,bradycardia,tachycardia,inconclusive andunreadable rhythm. TheFrontier X Plus isintended for use byhealthcareprofessionals, patientswith known orsuspected heartconditions andhealth-consciousindividuals. It isindicated for use onadult patients who maybe asymptomatic orwho may suffer fromtransient symptomsrequiring cardiacmonitoring. The devicehas not been tested forpediatric use. TheFrontier X Plus is aprescription-onlydevice, and the reportedinformation is providedfor review by aphysician who willrender a diagnosisbased on clinicaljudgment andexperience.	device, and the reportedinformation is providedfor review by a physicianwho will render adiagnosis based on clinicaljudgment and experience.	The KardiaMobile System isintended for use byhealthcare professionals,patients with known orsuspected heart conditionsand health-consciousindividuals. The device hasnot been tested and is notintended for pediatric use.
Mechanism ofAction	User completes circuitwith skin contact andhardware transmits	User completes circuitwith skin contact and	User completes circuit withskin contact and hardwaretransmits signal to
Feature	Frontier X Plus	QardioCore ECG Monitor	KardiaMobile,KardiaStation System
	signal toFrontier X Plus firmwareto convert and displayECG waveform	hardware transmits signaltoFrontier X Plus firmwareto convert and displayECG waveform	Frontier X Plus firmware toconvert and display ECGwaveform
Where used(intended use)	Mobile/active users atrest (ambulatory)	Mobile/active users atrest (ambulatory)	Mobile/active users at rest(ambulatory)
Anatomicalsites	On or below chest	On or below chest	Left hand fingers to righthand fingersLeft leg to right handfingers On or below chest
AvailableAlgorithms	Atrial FibrillationUnreadableNormal Sinus RhythmTachycardiaBradycardiaInconclusive	None	Atrial FibrillationNoise Algorithm(Unreadable/Inconclusive)Normal Sinus RhythmTachycardiaBradycardia
DataAcquisition:FrequencyResponse	0.05 Hz to 40 Hz	0.5 to 40 Hz	0.5 Hz to 40 Hz
ECG electrodes	Dry electrodes (Cheststrap - single use)	Dry electrodes	Dry electrodes
ECG channels	Single Channel	Single Channel	Single Channel
Resolution	16 bits	18 bits	16 bits
Sample Rate	500 samples / second(500 Hz)	125 samples / second(125Hz)	300 samples/second
Number of ECGLeads	Single lead, 2 electrodes	Single lead, 2 electrodes	Single lead, 2 electrodes
Power Supply:Battery	3.7V Li-Polymer Battery(rechargeable)	3.7V Li-Polymer Battery(rechargeable)	3.7V Li-Polymer Battery(rechargeable)
BatteryLife(typical)	3 years (500 full charges)	2 years	2 years (100 hours)
User Interface:Primary LeadDataacquisitionHardwareSoftwareinterface	Chest Strap to AppleiOS-based or GoogleAndroid-based softwarevia Bluetooth and viaembedded Frontier XPlus software	Chest Strap to AppleiOS-based or GoogleAndroid-based softwarevia Bluetooth	Lead I, Left to RightUltrasonic acousticsTwo-electrode sensorApple iOS-based or GoogleAndroid-based software
Feature	Frontier X Plus	QardioCore ECG Monitor	KardiaMobile,KardiaStation System
Physical Specs:DimensionsWeight	74mm x 26mm x 14mm23g (without strap)	185mm x 87mm x 9mm130g (including strap)	82mm x 32mm x 4mm15g
Prescribed:	Prescription	Prescription	Prescription and OTC
Communications	Bluetooth	Bluetooth	Ultrasonic Acousticsacquired by phone

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SUBSTANTIAL EQUIVALENCE

The Frontier X Plus subject device has the same intended use and similar technological characteristics as the QardioCore ECG Monitor predicate device. The differences in technological characteristics have been analyzed and addressed through performance testing. The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness.

PERFORMANCE DATA [807.92(b)]

All necessary performance testing was conducted on the Frontier X Plus to support a determination of substantial equivalence to the predicate device.

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

All necessary performance testing was conducted on the Frontier X Plus to support a determination of substantial equivalence to the predicate device. This testing included the following:

-Cybersecurity Testing
-Verification against the device's specifications
Software verification and validation -
-Signal integrity testing to evaluate impact of cleaning and aging
-Frontier X Plus validation using real-world data, supplementary clinical investigation data and human factors data
-Evaluation to the following standards:
- O ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 0 ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- International Standard ISO 10993 Fourth edition: 2021-11, Biological Evaluation of Medical 0 Devices Part 10: "Tests for Skin Sensitization". Reference Number: ISO 10993 -10:2021 (E).

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International Standard ISO 10993 First edition: 2021-01, Biological Evaluation of Medical 0 Devices Part 23: "Tests for Irritation". Reference Number: ISO 10993 -23:2021 (E).
O IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance,
ANSI IEEE C63.27-2017 American National Standard for Evaluation of O Wireless Coexistence.
FDA Guidance: Cybersecurity in Medical Devices: Quality System O Considerations and Content of Premarket Submissions
IEC 60601-1-2:2014+AMD1: 2020 CSV, Medical Electrical Equipment Part 1-2: O General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests,
IEC 60601-1-11:2015, Medical electrical equipment -- Part 1-11: General 0 requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and
IEC 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular 0 Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.
ANSI/AAMI EC57: 2012, Testing and Reporting Performance Results of Cardiac O Rhythm and ST Segment Measurement Algorithms (K200884)

[807.92(b)(1)] Clinical Testing Summary:

The Clinical Investigation Study was conducted in a population consistent with the subject device's indications for use. The study's objectives included a comparative evaluation of the clinical equivalence of ECG waveforms recorded by the subject device to simultaneously captured ECG waveforms from a reference device (Standard 12-lead ECG). The study further evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device. ECGs from the subject and reference devices were collected and analyzed at various time points representative of normal subject and reference device use. Various quantitative and qualitative metrics including relevant ECG waveform characteristics were measured and analyzed. The data provided demonstrated the substantial equivalence with the predicate device. The collective results of the performance testing demonstrate that the Frontier X Plus meets the established specifications and complies with the aforementioned standards.

A total of 832 users were included in the Study population. This included approximately 30% data

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from Females, 70% from Males, and approximately 66% from White/Caucasians, 5% Hispanic/Latino, 19% Asian, 5% Black and 4% other ethnic groups. As far as Age distribution is concerned, approximately 22% of Users were aged between 18-44, 56% were between 45-65 and 22% were 65 yrs and over. Of the total set of users that were part of the study population, 32% of users, i.e., 264 users had recorded episodes of Atrial Fibrillation. In terms of BMI, approximately 10% of users were below a BMI of 21, 40% had a BMI between 21 and 25, and 50% had a BMI greater than 25.

SUMMARY

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).