The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arthythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary.

The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arthythmias. The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.

The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI.

The DeepRhythm Platform 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

The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities.

The DeepRhythm Platform's functionality consists of:

enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users),
receiving the signal from a compatible monitoring device worn by the patient, .
using an external AI service for signal analysis and classification (not a part of the . subject device),
processing signal and annotations received from the external Al service, including . statistics computation,
· reviewing the signal and annotations by an ECG Technician user,
generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user,
reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report proving the device meets specific performance criteria. It primarily focuses on the regulatory submission information for FDA 510(k) clearance, asserting substantial equivalence to a predicate device.

Therefore, I cannot populate all the requested information. However, I can extract what is available and note the missing information.

Here's an analysis based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It generally states that "All necessary testing was conducted on the DeepRhythm Platform to support a determination of substantial equivalence to the predicate device. Test results confirm that DeepRhythm Platform meets its intended use."

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

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document mentions that the DeepRhythm Platform "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This suggests that the AI component's ground truth establishment might have been part of its own prior clearance, but details for the DeepRhythm Platform's specific testing are absent.

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

This information is not provided in the document. The DeepRhythm Platform's role is described as "interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only." This suggests it's an assistive tool, but a comparative effectiveness study with human readers is not detailed.

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

The document states that "DeepRhythm Platform utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This implies that the core algorithmic performance for detection is handled by the pre-cleared DeepRhythmAI. The DeepRhythm Platform "provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis," and processes statistics from DeepRhythmAI. However, specific standalone performance metrics for the DeepRhythm Platform's unique contributions (beyond DeepRhythmAI) are not detailed.

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

The type of ground truth used for this specific submission's testing is not explicitly stated. Given that it leverages a previously cleared AI for detection, the ground truth for the DeepRhythmAI algorithm itself would have been established during its clearance, likely through expert consensus with ECG interpretation. For the DeepRhythm Platform's own capabilities (processing, visualization, reporting), it would likely involve verification against established ECG processing standards and internal validation, but the ground truth method is not described.

8. The sample size for the training set

The document states that the DeepRhythm Platform "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This means the training of the core AI algorithm (DeepRhythmAI) would have been done prior to this submission as part of its own clearance. The sample size for the training of DeepRhythmAI is not provided in this document.

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

As in point 8, the ground truth for the DeepRhythmAI algorithm's training would have been established during its separate FDA clearance. Details on this ground truth establishment are not provided in this document.

Summary

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June 20, 2024

Medicalgorithmics S.A. % Joanna Dabala Product Compliance Leader Medicalgorithmics US Holding Corporation Corporation Service Company 251 Little Falls Drive Wilmington, Delaware 19808

Re: K232161

Trade/Device Name: DeepRhythm Platform Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK Dated: February 29, 2024 Received: February 29, 2024

Dear Joanna Dabala:

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" (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).

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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.

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 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 W. Shih -S

Jennifer Shih 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

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Indications for Use

510(k) Number (if known) K232161

Device Name DeepRhythm Platform

Indications for Use (Describe)

The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arthythmias using ECG data in adult patients.

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

1 Submitter's name and address

Medicalgorithmics S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland

Contact Person: Joanna Dąbała Phone: (+48) 733888448 Email: j.dabala@medicalgorithmics.com

Date Prepared: June 14, 2024

N Device

Trade name	DeepRhythm Platform
Common name	DR Platform, DRP
Classification name	ElectrocardiographProgrammable Diagnostic Computer
Regulation number	21 CFR § 870.234021 CFR § 870.1425
Regulatory Class	Class II
Product Codes:	DPS, DQK

3 Predicate device

The selected predicate device is:

Cardiologs Holter Platform (K212112) -

4 Device description

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The DeepRhythm Platform's functionality consists of:

enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users),
receiving the signal from a compatible monitoring device worn by the patient, .
using an external AI service for signal analysis and classification (not a part of the . subject device),
processing signal and annotations received from the external Al service, including . statistics computation,
· reviewing the signal and annotations by an ECG Technician user,
generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user,
reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).

5 Indications for use

The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in adult patients.

The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when retrospective assessment of the rhythm is necessary.

The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arrhythmias.

The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.

The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAl.

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Guidance documents 6

The following guidance documents have been taken into account during the preparation of this submission:

1. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Guidance for Industry and Food and Drug Administration Staff (July 28, 2014):
Content of Premarket Submissions for Software Contained in Medical Devices, 2. Guidance for Industry and Food and Drug Administration Staff (May 11, 2005);
Content of Premarket Submissions for Management of Cybersecurity in 3. Medical Devices, Guidance for Industry and Food and Drug Administration Staff (October 2, 2014);
1. Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act., March 30,2023
1. Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (September 27, 2019);
1. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff (September 6, 2017);
General Principles of Software Validation, Guidance for Industry and Food and 7. Drug Administration Staff (January 11, 2002);
Applying Human Factors and Usability Engineering to Medical Devices, 8. Guidance for Industry and Food and Drug Administration Staff (February 3, 2016);
Multiple Function Device Products: Policy and Considerations, Guidance for 9. Industry and Food and Drug Administration Staff (July 29, 2020),
1. Postmarket Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (December 28, 2016);

Referenced standards 7

The DeepRhythm Platform meet the requirements of the following performance standards in accordance with FDA recognized consensus standards:

1. AAMI/ANSI/IEC 60601-2-47:2012 /(R)2016, Medical Electrical Equipment -Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems;
1. IEC EN 60601-2-25 Edition 2.0 2011-10, Medical electrical equipment -Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs;
1. ANSI AAMI IEC 62304:2006/A1:2016 Medical device software Software life cycle processes [Including Amendment 1 (2016)];

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1. ANSI AAMI ISO 14971 :2019 Medical devices Applications of risk management to medical devices;
1. ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices - Part 1: Application of usability engineering to medical devices.

8 Performance data

Software Verification and Validation Testing 8.1

Software verification and validation testing were conducted and documented.

The DeepRhythm Platform has been subjected to evaluation according to the applicable clauses of recognized consensus standard, ANSI/AAMI/IEC 60601-2-47:2012 /(R)2016 and IEC EN 60601-2-25 Edition 2.0 2011-10.

The Medicalgorithmics S.A. followed ANSI/AAMI/IEC 62304 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.

All necessary testing was conducted on the DeepRhythm Platform to support a determination of substantial equivalence to the predicate device. Test results confirm that DeepRhythm Platform meets its intended use.

The software was considered an Enhanced Level of Documentation as a design flaw or failure could directly or indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of care provider.

8.2 Usability Engineering

The DeepRhythm Platform went under the usability engineering study. It was performed according to the FDA guidance and standards: Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Administration Staff (February 3, 2016) and ANSI AAMI Drug IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices - Part 1: Application of usability engineering to medical devices.

Substantial Equivalence Conclusion 8.3

The DeepRhythm Platform is substantially equivalent to the marketed predicate device - Cardiologs Holter Platform, which already has the 510(k) clearance -K212112.

Both devices - DeepRhythm Platform and Cardiologs Technologies are software products intended for use by a qualified and trained professionals for assessment of arrhythmias. Differences between the proposed device and predicate device are minor and have no impact on the safety and the effectiveness of the product. Descriptive characteristics and performance testing were used to demonstrate substantial equivalence.

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In the tables below are demonstrated similarities and differences between the proposed and predicate device.

Characteristics	DeepRhythm Platform(Proposed device)	Cardiologs HolterPlatform(Predicate device)
Manufacturer	Medicalgorithmics S.A.	Cardiologs Technologies
510(k) number	K232161	K212112
Classification	Class II	Class II
Regulation Number(s)	21 CFR 870.234021 CFR § 870.1425	21 CFR 870.234021 CFR § 870.1425
Classification name	ElectrocardiographProgrammable DiagnosticComputer	ElectrocardiographProgrammable DiagnosticComputer
Product code	DPS, DQK	DPS, DQK
Components	Software only	Software only
Display Options	Computer	Computer
Algorithm	Proprietary algorithm	Proprietary algorithm
Multiplemonitoringmode options	Holter, Event recorder	Holter, event recorder,12 lead ECG device
Intended users	Qualified and trainedhealthcare professionals	Qualified healthcareprofessionals
Alarm function	No	No
Characteristics	DeepRhythm Platform(Proposed device)	Cardiologs HolterPlatform(Predicate device)
Manufacturer	Medicalgorithmics S.A.	Cardiologs Technologies
Level of concern	Major	Moderate
Patient population	Adult	Adult and Pediatric
Fundamentalscientifictechnology	DeepRhythm Platformconsists of:A software interfaceintended for analysis,review, assessment andreporting of arrhythmiasusing ECG data acquiredfrom a compatible device,coded in C# andTypescript languages,under the React and .NETframeworks.DeepRhythm Platformis compatible with anexternal Al service forECG analysis,Medicalgorithmics'DeepRhythmAl, whichperforms QRS complexesand arrhythmia detectionon the ECG signal.Additionally, DeepRhythmPlatform performsstatistical processing ofresults of data analysisreceived fromDeepRhythmAI.	The Cardiologs HolterPlatform consists of:An interface whichprovides tools tomeasure, analyze andreview numerous ECGscoded in java languageunder the Angular andD3.js frameworks;An automated proprietaryECG interpretationsupport algorithm whichmeasures and analyzesECGs to providesupportive information forECG diagnosis, written inPython language. Thisapplication can beaccessed through anInternet connection and aweb browser, or is directlyconnected to theCardiologs' ApplicationProgramming Interface(API).
Characteristics	DeepRhythm Platform(Proposed device)	Cardiologs HolterPlatform(Predicate device)
Compatible devices	The DeepRhythmPlatform supportsdownloading andanalyzing data recordedin compatible formatsfrom 1-channel and2-channel ambulatoryECG recording devicesused for the arrhythmiadiagnostics such asHolter, event recorder, orother similar deviceswhen assessment of therhythm is necessary.	The product supports datarecorded in compatibleformats from any deviceused for the arrhythmiadiagnostics suchas Holter, event recorder,12 lead ambulatory ECGdevices, or other similardevices when assessmentof the rhythm isnecessary.

Table 1 Similarities – between proposed and predicate device

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Table 2 Differences – between proposed and predicate device

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Conclusion 9

The DeepRhythm Platform is substantially equivalent to the predicate device as supported by the descriptive information and the performance testing. The nonclinical data support the safety of the device and software verification and validation demonstrate that the DeepRhythm Platform should perform as intended in the specified use conditions.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).