(101 days)
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."
| 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).
§ 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).