The WorkMate Claris System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.

The WorkMate Claris System is connected to electrophysiology catheters that are guided into various locations within the heart, and to surface electrocardiogram (ECG) cables. Intracardiac and ECG signals are then acquired from electrodes on the indwelling catheters and ECG leads connected to the amplifier, which amplifies and conditions the signals before they are received by the WorkMate Claris System computer for display, measurement and storage.

During the procedure, cardiac signals are acquired and an automated software waveform detector (trigger) performs online recognition of cardiac activation on preselected leads. Temporal interval measurements are computed on a beat-by-beat basis on multiple channels and dynamically posted on the Real Time display. Intervals are calculated between waveforms from the same source on a specific channel (intra-channel measurements) and from multi-source signals across two or more channels (inter-channel measurements).

Signals are also presented on a review monitor for measurement and analysis. Continuous capture of the digitized signals can be invoked, and the user can also retrieve and display earlier passages of the current study without interruption of the real-time display. The system can also acquire, display and record data from other interfaced devices in use during the procedure, such as imaging devices and ablation generators.

The WorkMate Scribe™ Module is an optional integrated monitoring and review station for the WorkMate Claris System that allows a separate user to review and edit current patient study data stored on the WorkMate Claris System and monitor patient data from the WorkMate Claris System during the patient study. The WorkMate Scribe Module consists of a PC, a touch screen LCD monitor and cart connected via Ethernet to a WorkMate Claris System. Vital signs measurements can be imported from an optional external Physiological Module (Smiths Medical Advisor™ Vital Signs Monitor herein referred to as Physio Monitor).

AI/ML Overview

This document, a 510(k) summary for the WorkMate Claris™ System (K151911), primarily discusses a software upgrade and does not contain detailed acceptance criteria for specific performance metrics that would typically be seen in a study proving device performance against such criteria. Instead, it focuses on demonstrating that the software modifications do not affect the safety or effectiveness of the device and that the updated system maintains substantial equivalence to its predicate device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, effect size, standalone study, ground truth type for test/training set, training set sample size, ground truth for training set) cannot be fully answered from the provided text as they are not explicitly detailed.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "design verification activities for functional testing" and "performance tests" that were conducted. The acceptance criteria are broadly defined as ensuring that "the software modifications do not affect the safety or effectiveness of the device" and that "all testing performed met the established performance specifications." The reported performance is that "Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence."

Acceptance Criteria (General)	Reported Device Performance (General)
Software modifications do not affect the safety or effectiveness of the device.	All testing performed met the established performance specifications. Results were acceptable in supporting the claim of substantial equivalence.
Established performance specifications are met.	All testing performed met the established performance specifications. Results were acceptable in supporting the claim of substantial equivalence.
WorkMate Claris™ System conforms to referenced standards (IEC 60601-1-2, IEC 60601-1, ISO 14971, IEC 62366, cybersecurity requirements).	Conformance to these standards is indicated. Risk analysis was completed, and risk controls were implemented. Cybersecurity risk management process was followed.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "design verification activities for functional testing" and "performance tests" but does not provide the sample size of cases or data used for these tests.
Data Provenance: Not specified. The testing is described as "in-house testing," suggesting it was conducted by the manufacturer. No information on the country of origin or whether the data was retrospective or prospective is given.

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

Not applicable/Not specified. The document does not describe a study involving expert review for establishing ground truth on a test set. The testing performed appears to be functional and performance testing of the software itself rather than evaluation against clinical ground truth.

4. Adjudication method for the test set

Not applicable/Not specified. Without a description of expert review or clinical ground truth establishment, no adjudication method is mentioned.

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

Not applicable. The WorkMate Claris™ System is described as a "fully computerized system for capturing and measuring physiological data" and providing "digital signal acquisition and display." It performs "online recognition of cardiac activation" and computes "temporal interval measurements." This is a diagnostic computer system processing physiological signals, not an AI or imaging device where human reader performance would typically be enhanced or compared via an MRMC study.

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

Yes, implicitly. The "design verification activities for functional testing" and "performance tests" would have evaluated the software's functionality and performance as a standalone algorithm/system. The device itself is described as a "fully computerized system."

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

Not explicitly stated. Given the nature of the device (acquiring and measuring physiological data, online recognition of cardiac activation, temporal interval measurements), the "ground truth" for the functional and performance testing would likely involve:

Known input signals: Testing the system's accuracy in acquiring, displaying, and measuring pre-defined or simulated physiological signals with known characteristics.
Expected output values: Comparing automated measurements (e.g., temporal intervals) against expected or manually verified correct values from the input signals.
System specifications: Verifying that the system operates according to its design specifications for data acquisition, processing, and display.

This is more about technical validation than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This device is an electrophysiology data acquisition and measurement system, not a machine learning or AI algorithm that typically requires a large training set in the conventional sense. The "software upgrade" focuses on operating system updates, minor customer enhancements, addressing anomalies, and updating SOUP/OTS programs, not on retraining a core algorithm with new data.

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

Not applicable (see point 8).

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

October 22, 2015

St. Jude Medical Melissa Frank Senior Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, MN 55117

Re: K151911

Trade/Device Name: WorkMate Claris System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 17, 2015 Received: September 22, 2015

Dear Melissa Frank:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related 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,

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) K151911

Device Name WorkMate Claris™ System

Indications for Use (Describe)

The WorkMate Claris™ System is indicated for use during clinical electrophysiology procedures.

The WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510KSUMMARY

510(k) Number	K151911
Date Prepared	09-July-2015
Submitter Information	St. Jude MedicalOne St. Jude Medical DriveSt. Paul, MN 551177
ManufacturerName/Address

Contact Person	Melissa FrankSr. Regulatory Affairs SpecialistPhone (651) 756-2954Mfrank02@sjm.com



Device Information
Trade Name	WorkMate Claris™ System
Common Name	Programmable Diagnostic Computer
Class	II
Classification Name	870.1425, computer, diagnostic, programmable DQK
Predicate Device	WorkMate Claris System K132073
Device Description	The WorkMate Claris System is a fully computerized system for capturing andmeasuring physiological data in the clinical electrophysiology (EP) laboratory.It provides digital signal acquisition and display of those electrical signals onhigh resolution monitors.The WorkMate Claris System is connected to electrophysiology catheters thatare guided into various locations within the heart, and to surfaceelectrocardiogram (ECG) cables. Intracardiac and ECG signals are thenacquired from electrodes on the indwelling catheters and ECG leads connectedto the amplifier, which amplifies and conditions the signals before they arereceived by the WorkMate Claris System computer for display, measurementand storage.During the procedure, cardiac signals are acquired and an automated softwarewaveform detector (trigger) performs online recognition of cardiac activationon preselected leads. Temporal interval measurements are computed on a beat-by-beat basis on multiple channels and dynamically posted on the Real Timedisplay. Intervals are calculated between waveforms from the same source on aspecific channel (intra-channel measurements) and from multi-source signalsacross two or more channels (inter-channel measurements).Signals are also presented on a review monitor for measurement and analysis.Continuous capture of the digitized signals can be invoked, and the user canalso retrieve and display earlier passages of the current study withoutinterruption of the real-time display. The system can also acquire, display andrecord data from other interfaced devices in use during the procedure, such asimaging devices and ablation generators.

	The WorkMate Scribe™ Module is an optional integrated monitoring andreview station for the WorkMate Claris System that allows a separate user toreview and edit current patient study data stored on the WorkMate ClarisSystem and monitor patient data from the WorkMate Claris System during thepatient study. The WorkMate Scribe Module consists of a PC, a touch screenLCD monitor and cart connected via Ethernet to a WorkMate Claris System.Vital signs measurements can be imported from an optional externalPhysiological Module (Smiths Medical Advisor™ Vital Signs Monitor hereinreferred to as Physio Monitor).
Indications for Use	The WorkMate Claris System is indicated for use during clinicalelectrophysiology procedures
	The WorkMate Claris™ System is a fully computerized system for capturingand measuring physiological data in the clinical electrophysiology (EP)laboratory. It provides digital signal acquisition and display of those electricalsignals on high resolution monitors.
Predicate Comparison	The proposed WorkMate Claris System software upgrade v1.1, which includesthe WorkMate Scribe Module, has the same intended use and fundamentalscientific technology as the predicate device, WorkMate Claris System v1.0.The WorkMate Claris and WorkMate Scribe software v.1.1 software upgradehas four main objectives:1. The main objective for the software upgrade is to update the operatingsystem from Window XP to Windows 7. Microsoft announced thatWindows XP has ended life and Microsoft will not continue to supportWindows XP.2. The second objective for the software upgrade is to add a few minor newcustomer enhancement software features that have been identified throughvoice of customer (VOC).3. The third objective of the upgrade is to address software anomalies thatwere identified either through in-house testing or product surveillance.4. The fourth objective of the upgrade is to update the Software of UnknownProvenance (SOUP)/ Off-the-Shelf (OTS) programs
Non-Clinical TestingSummary	Design verification activities for functional testing were performed with theirrespective acceptance criteria to ensure that the software modifications do notaffect the safety or effectiveness of the device. All testing performed met theestablished performance specifications. Performance tests were conducted totest the functionality of the WorkMate Claris™ System. These tests have beenperformed to assess the functionality of the subject device. Results of allconducted testing were found acceptable in supporting the claim of substantialequivalence.
	The WorkMate Claris System software is developed and tested in accordancewith the following industry guidance documents and standards:• FDA Reviewers and Compliance on Off-the-Shelf Software used inMedical Devices and IEC 62304 OTS classification• Guidance for the Content of Premarket Submissions for Software
	Contained in Medical Devices
	IEC 62304:2006 Medical Device Software - Software Life Cycle Processes Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
	Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as part of this submission.
	Software Documentation for OTS software classified as a Minor Level of Concern, Class B according the FDA guidance, FDA Reviewers and Compliance on Off-the-Shelf Software used in Medical Devices and IEC 62304 OTS classification is included as part of this submission.
	The changes to the application software and operating system were evaluated through software verification and validation to show that the application software is acceptable for use and meets the requirements.
	The WorkMate Claris System conforms to the following standards: IEC 60601-1-2 (2007) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic disturbances - requirements and tests IEC 60601-1 (2005 + CORR.1 (2006) + CORR.2 (2007)) Medical electrical equipment- Part 1: General requirements for basic safety and essential performance ISO 14971 (2012) Medical Devices – Applications of risk management to medical devices IEC 62366 (2007) Medical devices – Application of usability engineering to medical devices
	Risk ManagementThe changes to the application software and operating system were evaluated through review of risk management to ensure no new hazards have been introduced by this change. The risk analysis was completed and risk controls were implemented to mitigate identified hazards.
	The WorkMate Claris™ System conforms to the Cybersecurity requirements through the cybersecurity risk management process comprised of a risk assessment, risk control, and maintenance of cybersecurity activities.
Statement of Equivalence:	The WorkMate Claris System which includes the WorkMate Scribe Module has the same indications for use as the predicate devices. The technological characteristics for the devices are the same as the predicate devices. Based on this and the data provided in this pre-market notification, the subject devices and predicate devices have been shown to be substantially equivalent.

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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).