(29 days)
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:
| Acceptance Criteria Category | General Acceptance Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|---|
| Functional Performance | Continuous and accurate acquisition, display, measurement, and storage of physiological (EP) data. | "All testing performed met the established performance specifications." |
| System Compatibility | Compatibility with existing EP lab equipment and indwelling catheters. | "that the system remains compatible with common electrophysiology lab equipment." |
| Software Integrity | Software functions as intended, free from critical bugs introduced by updates. | "Software verification testing to ensure the software continues to meet requirements..." |
| Installation Process | Successful update installation without errors or system degradation. | "Design validation studies to ensure the installation process... meets requirements." |
| Security | Maintenance or improvement of security posture with new OS and software versions. | "security updates/enhancements" |
| Risk Assessment | No new or increased risks identified due to modifications. | "review of risk management to ensure no new hazards have been introduced by this change." |
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.
§ 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).