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The WorkMate Claris™ System is indicated for the 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.

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. The cardiac stimulator integrated with the parent recording system, sends electrical impulses to indwelling catheters through the Amplifier.

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 provided text describes regulatory information for the Abbott WorkMate Claris™ System (K210392), which is a Special 510(k) submission. This type of submission is used when a modification to a legally marketed device does not alter its fundamental scientific technology, intended use, or indications for use, and does not raise new questions of safety and effectiveness.

Such submissions typically rely on design verification and validation testing to demonstrate that the changes have not adversely affected the device's performance or safety, rather than extensive clinical studies that prove efficacy or comparative effectiveness with human readers. The document explicitly states: "The changes are limited to the modification of system software to support an operating system update to Windows® 10, to manage end of life components, security updates/enhancements, and address software bug fixes." It also notes: "There are no new or increased risks that result from the modifications and the changes do not raise any new questions of safety and effectiveness in regards to the subject device."

Therefore, the study proving the device meets acceptance criteria primarily involves non-clinical functional and design validation testing, rather than clinical trials involving human subjects or AI-assisted performance studies as might be seen for novel AI/ML devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria or detailed numerical performance metrics for the WorkMate Claris System (v1.2) itself. Instead, it indicates that:

• Acceptance Criteria: "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the proposed modifications do not affect the safety or effectiveness of the device."
• Reported Device Performance: "All testing performed met the established performance specifications."

Given the nature of a Special 510(k) for a software and hardware update, the acceptance criteria would be focused on maintaining the existing established performance specifications of the predicate device (WorkMate Claris™ System v1.1). These would generally involve:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases. The testing described is primarily non-clinical design verification and validation. This would involve testing the system with various simulated inputs, hardware configurations, and software functionalities.
• Data Provenance: Not applicable as the testing is non-clinical system performance validation, not studies on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts/Qualifications: This is not applicable in the context of this Special 510(k) submission. The review of the device's performance against its specifications would be done by engineers, quality assurance personnel, and potentially clinical subject matter experts for functional validation, but not typically in a formal "ground truth" establishment sense for a test set of medical cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no mention of a human-in-the-loop performance study or a test set requiring adjudication in the medical context (e.g., image interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is for software and hardware updates to an existing device, not for a new AI/ML diagnostic algorithm that assists human readers. The document highlights that the device "uses the same fundamental scientific technology, intended use, and indications as the predicate device."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Not applicable in the context of AI/ML algorithm performance. The device is a physiological data acquisition and display system; its "performance" is based on the accuracy and reliability of its data capture and presentation capabilities, not on a diagnostic algorithm's output. The document describes "functional testing" and "software verification testing" which are forms of standalone performance validation for the system as a whole.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be established by the device's functional specifications and requirements. For example, if the system is designed to measure a specific temporal interval within ±X milliseconds, then the "ground truth" for testing would be the known, precisely controlled input signal, and the device's output would be compared against that known value.
  • This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather engineering-level validation against known performance standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML model that undergoes a "training" phase with a dataset. It's a deterministic system for acquiring and displaying physiological signals.

9. How the Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

In summary, the K210392 submission for the WorkMate Claris™ System v1.2 is a "Special 510(k)" based on modifications to an existing device. The acceptance criteria and supporting studies are focused on non-clinical design verification and validation to ensure that the updated device maintains its safety and effectiveness and performs according to its established specifications, without introducing new risks. It does not involve clinical studies, multi-reader studies, or AI algorithm training/testing.

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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.

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).

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."

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).

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