RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analysing data recorded in compatible formats from any FDA cleared device used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when of the rhythm is necessary. RhythmAnalytics can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. RhythmAnalytics provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. RhythmAnalytics is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

RhythmAnalytics interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Device Description

RhythmAnalytics consists of (1) A web application programming interface (API) which an authentic user to upload single-lead ECG data and reports ECG interpretation results, and (2) An automated proprietary algorithm, i.e., cardiac beats/arrhythmias detection which measures and analyzes ECG data to provide qualified healthcare professional supportive information for review.

RhythmAnalytics is only intended to analyze recordings performed on adults (over the age of 18). RhythmAnalytics works in the following sequence:

Accept uploading digital ECG files via secure API;
Analyse the uploaded ECG using RhythmAnalytics proprietary algorithm, which detects cardiac beats/arrhythmias and intervals including:
- Heart rate determination
- RR Interval measurements
ORS
Non-paced arrhythmias
Non-paced ventricular arrhythmia calls
Ventricular ectopic beats
RhythmAnalytics returns the interpretation result to be reviewed by a qualified healthcare professional.

AI/ML Overview

The provided text describes the RhythmAnalytics device and its clearance by the FDA. Let's break down the information to address your specific questions about acceptance criteria and the study proving the device meets them.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria with specific numerical thresholds for metrics like sensitivity or specificity side-by-side with reported performance. Instead, it states that "Performance testing included the evaluation of sensitivity, specificity, and positive and negative values. All clinical input requirements were validated against a gold standard." It also mentions "No residual anomalies appeared during verification and software validation tests." and that "All software validation testing was completed successfully and met all requirements."

While the document confirms these metrics were evaluated and requirements were met, it does not provide the specific numerical acceptance criteria (e.g., "Sensitivity must be >90%") nor the reported numerical performance values (e.g., "Achieved Sensitivity: 92%").

Therefore, for question 1, I can only state what the document says was evaluated, but not the specific quantitative details.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Software functions as intended	All software validation testing completed successfully and met all requirements. No residual anomalies appeared.
Sensitivity (for arrhythmia detection)	Evaluated and validated against a gold standard. (Specific values not provided)
Specificity (for arrhythmia detection)	Evaluated and validated against a gold standard. (Specific values not provided)
Positive Predictive Value (for arrhythmia detection)	Evaluated and validated against a gold standard. (Specific values not provided)
Negative Predictive Value (for arrhythmia detection)	Evaluated and validated against a gold standard. (Specific values not provided)
Usability	General usability tests (login, upload, review, download) performed and met all requirements.
Compliance with relevant standards (IEC 62304, FDA Guidance, AAMI/ANSI EC57:2012, IEC 62366-1)	Followed and completed in compliance with listed standards and guidance documents.

Let's address the remaining questions based on the provided text:

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

The document does not explicitly state the sample size used for the test set for performance evaluation (sensitivity, specificity, etc.) nor does it specify the data provenance (country of origin, retrospective/prospective). It only mentions "All clinical input requirements were validated against a gold standard."

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

The document does not provide information on the number of experts used to establish the ground truth for the test set, nor their specific qualifications. It only states that validation was performed "against a gold standard."

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

The document does not specify any adjudication method used for establishing the ground truth of the test set. It only refers to a "gold standard."

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as providing "supportive information for review" to "qualified healthcare professionals" and its interpretation results "are not intended to be the sole means of diagnosis." This suggests it's an assistive tool, but no study on human-AI collaboration performance or effect size is detailed.

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

Yes, a standalone performance evaluation was done. The "Summary of Performance Testing" section states, "Performance testing included the evaluation of sensitivity, specificity, and positive and negative values. All clinical input requirements were validated against a gold standard." This indicates the algorithm's performance was assessed independently against a "gold standard."

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

The document explicitly states that "All clinical input requirements were validated against a gold standard." However, it does not specify the precise nature of this "gold standard" (e.g., whether it was expert consensus, pathology, or another form of definitive diagnosis).

8. The sample size for the training set

The document does not provide the sample size used for the training set of the proprietary algorithm.

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

The document does not describe how the ground truth for the training set was established. It only refers to the algorithm as an "automated proprietary algorithm, i.e., cardiac beats/arrhythmias detection which measures and analyses ECG data."

Summary

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March 7, 2019

Biofourmis Singapore Pte. Ltd. % Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460

Re: K182344

Trade/Device Name: RhythmAnalytics Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DPS Dated: February 1, 2019 Received: February 5, 2019

Dear Michael Daniel:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica E. Paulsen -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K182344

Device Name RhythmAnalytics

Indications for Use (Describe)

The product can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

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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Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K182344

Applicant Information:

Date Prepared:	March 01, 2019
Name:	Biofourmis Singapore Pte.Ltd.
Address:	Vision Exchange, #07-152 Venture DriveSingapore 608526

Contact Person:	Michael A Daniel, Consultantmadaniel@clinregconsult.com
Mobile Number:	(415) 407-0223
Office Number:	(775) 392-2970
Facsimile Number:	(610) 545-0799

Device Information:

Trade Name:	RhythmAnalytics
Common Names:	ECG Analysis System
Classification Name(s):	Programmable Diagnostic Computer/Electrograph
Product Code/ Regulation:	DQK, 21 CFR 870.1425DPS, 21 CFR 870.2340
Classification:	Class II

Predicate Device:

. CardioLogs ECG Analysis Platform – K170568

Device Description:

RhythmAnalytics is only intended to analyze recordings performed on adults (over the age of 18). RhythmAnalytics works in the following sequence:

Accept uploading digital ECG files via secure API;
Analyse the uploaded ECG using RhythmAnalytics proprietary algorithm, which detects ● cardiac beats/arrhythmias and intervals including:
- o Heart rate determination
- o RR Interval measurements

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ORS o
Non-paced arrhythmias o
Non-paced ventricular arrhythmia calls o
Ventricular ectopic beats O
RhythmAnalytics returns the interpretation result to be reviewed by a qualified healthcare ● professional.

Indications for Use:

RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analysing data recorded in compatible formats from any FDA cleared device used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when assessment of the rhythm is necessary. RhythmAnalytics can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. RhythmAnalytics provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. RhythmAnalytics is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Summary Comparison to Predicate:

The following tables provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and substantially equivalent characteristics that do not raise different questions of safety or effectiveness.

Comparison to Predicate Device:

The following table provides a comparison of the detection features and device comparison of RhythmAnalytics and the predicate device:

Detection Features comparison:

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Detection Feature	RhythmAnalytics	CardioLogsECG AnalysisPlatform
Heart rate determination for non-paced adult	Yes	Yes
QRS Detection	Yes	Yes
Non-paced arrhythmia interpretation for adultpatients	Yes	Yes
Non-paced ventricular arrhythmia calls	Yes	Yes
Intervals measurements	Yes	Yes
Ventricular ectopic beat detection	Yes	Yes
Patient Population	Adult	Adult

Device comparison:

	Subject device	Predicate Device	Comparison topredicatedevice
Device Name	RhythmAnalytics	CardioLogs ECG AnalysisPlatform	N/A
Manufacturer	Biofourmis Singapore Pte.Ltd.	CardioLogs Technologies	N/A
510(k) #	K182344	K170568	N/A
RegulationNumber	21 CFR 870.142521 CFR 870.2340	21 CFR 870.142521 CFR 870.2340	Same
Class	II	II	Same
DeviceClass/Name	Electrocardiograph	Electrocardiograph	Same

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	Subject device	Predicate Device	Comparison topredicatedevice
Product Code	DPS, DQK	DPS, DQK	Same
Level ofConcern	Major	Moderate	Different

	Subject device	Predicate Device	Comparison topredicate device	Safety Impact	Effectivenessimpact
Indication for Use	Refer to Section"Indications for Use"	Refer to K170568,Section 7.2	Both devices areintended for the sameuse.	No impact.Same for indicationfor use.	No impact.Same forindication for use
Fundamentalscientifictechnology	RhythmAnalyticsconsists of:	CardioLogs ECGAnalysis Platformconsists of:	RhythmAnalytics andthe predicate deviceboth consists of:
	1. A web applicationprogramming interface(API) which allowsuploading of ECG dataand generate ECGinterpretation results.	1. An interfacewhich providestools to measure,analyses andreview numerousECGs coded injava languageunder the Angularand D3.jsframeworks;	1. A cloud-based APIthat works the sameway.	No impact.	No impact.Both providesimilar interfacebut coded indifferenceprogramminglanguage whichshould not causeany effectivenessimpact.
	2. An automatedproprietary algorithm,i.e., cardiacbeats/arrhythmiasdetection whichmeasures and analysesECG data to providequalified healthcareprofessionalsupportive informationfor review.	2. An automatedproprietary ECGinterpretationsupport algorithmwhich measuresand analysesECGs to providesupportiveinformation forECG diagnosis,written in Pythonlanguage.	2. Automatedproprietary algorithmto detect cardiacarrhythmias, heartrate and intervalmeasurements.	No impact.Both providedarrhythmiainterpretation arenot intended to bethe sole means ofdiagnosis. Theinterpretations areoffered tophysicians andclinicians on anadvisory orassistive basis.	No impact.The difference inprogramminglanguageshouldn't makeany effect onalgorithms.
	Any healthcare	This application	RhythmAnalytics
Subject device	Predicate Device	Comparison topredicate device	Safety Impact	Effectivenessimpact
leveraging on ourRhythmAnalytics APIcan build web ormobile application tolet qualified healthcareprofessional reviewand confirmation theanalytic result.	through anInternetconnection and aweb browser or isdirectly connectedto the CardioLogs'API.	present any majortechnologicalinnovations comparedto the predicatedevice.

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Summary of Performance Testing

Tests have been performed in compliance with the appropriate recognized consensus standards. Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. Performance testing included the evaluation of sensitivity, specificity, and positive and negative values. All clinical input requirements were validated against a gold standard. No residual anomalies appeared during verification and software validation tests. General usability tests, analyzing the users' ability to login, upload, review and download were performed and met all requirements. All software validation testing was completed successfully and met all requirements.

Software

Biofourmis followed IEC 62304:2015 and the FDA Guidance Document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation. The Biofourmis software is classified as a "major level of concern" per the FDA guidance document.

Verification and validation testing was completed in compliance with the following standards and guidance documents:

AAMI ANSI IEC 62304:2015, Medical device software Software life cycle processes ●
General Principles of Software Validation; Final Guidance for Industry and FDA Staff" . (January, 2002)
AAMI/ANSI EC57:2012 - Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms
IEC 62366-1 Edition 1.0 2015-02 Medical devices Application of usability ● engineering to medical devices

Conclusion

Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, RhythmAnalytics has been shown to be substantially equivalent to the legally-marketed predicate.

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).