Search Results

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

The WorkMate Claris System is a computer-based electrophysiological recording and monitoring system that is used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies. It consists of a computer, two 23" high-resolution monitors, a multi-channel signal amplifier and filtering system (signal conditioning unit), one or two catheter input modules (CIMs), a printer, and carts. The system may also be configured with an integrated EP-4TM Cardiac Stimulator and touch-screen computer monitor (cleared in K092913).

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 multiple channels on a beat-by-beat basis and dynamically displayed on the real-time display. Menu-driven software is utilized for data acquisition and analysis, interval posting, and instant data retrieval with waveform markers and intervals displayed.

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 realtime 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 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). Patient data stored on the WorkMate Claris System can be reviewed, measured and annotated. Real Time signals currently being acquired by the WorkMate Claris System can be viewed. The product is an add-on extension of the WorkMate Claris System that allows a second user to view and annotate a study in parallel with the System user.

The provided text describes the St. Jude Medical WorkMate Claris System, a computer-based electrophysiological recording and monitoring system, and its associated Scribe Module. However, it does not explicitly detail a study conducted to demonstrate the device's fulfillment of specific acceptance criteria in the manner requested.

Instead, the document focuses on the regulatory submission process (510(k)) and demonstrates substantial equivalence to predicate devices. The "Summary on Non-Clinical Testing" section mentions that the device was designed and tested to applicable safety standards and St. Jude Medical SOPs, including design controls and risk analysis. It states that "Design verification activities for mechanical and functional testing were performed with their respective acceptance criteria to ensure that the hardware and limited software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." This indicates that internal testing was conducted against performance specifications, which serve as acceptance criteria, but no specific study details are provided.

Therefore, many of the requested details cannot be extracted from this document, as a formal clinical or comparative effectiveness study with specified sample sizes, ground truth establishment, or expert adjudication, as commonly seen for AI/ML device evaluations, is not described.

Here's a breakdown of what can be gleaned and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document mentions "established performance specifications" and implies that "design verification activities for mechanical and functional testing were performed with their respective acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not listed.
• Reported Device Performance: Similarly, the document states "All testing performed met the established performance specifications," but the specific performance results that demonstrate this achievement are not provided.

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

Not explicitly stated in the document. The document refers to "design verification activities" and "bench testing," which implies internal testing rather than a clinical study with a "test set" in the context of data-driven performance evaluation.

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

Not applicable/mentioned. The document does not describe a process of establishing ground truth using experts, as might be done for AI/ML performance evaluation. The testing appears to be primarily focused on meeting hardware and software functional specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/mentioned. An adjudication method is typically used to establish ground truth in studies involving human interpretation or performance assessment, which is not detailed here.

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

No MRMC comparative effectiveness study is described. The device is a "Programmable Diagnostic Computer" for recording and monitoring, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study.

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

This document describes a medical device system, not a standalone algorithm. The "automated software waveform detector (trigger)" performs online recognition, which is an algorithmic function. The document states that "design verification activities... for... limited software modifications do not affect the safety or effectiveness," implying standalone software testing was part of the internal verification, but no detailed study or results focusing solely on this algorithmic performance are provided.

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

Not explicitly mentioned for any "test set." The "ground truth" for the device's functional performance would have been defined by its established engineering specifications and expected operational parameters, as opposed to clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable/mentioned. The device is not described as an AI/ML device that undergoes a training phase using a specific dataset.

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

Not applicable/mentioned. (Refer to point 8).

Ask a specific question about this device

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

The EP-WorkMate® system with an EP-4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping.

The EP-WorkMate system is a computer-based electrophysiological recording and monitoring system that is used to capture, display, store, and retrieve surface and intracardiac electrical signals during electrophysiology studies. It consists of a computer. two 21" high-resolution monitors, a multi-channel signal amplifier and filtering system (signal conditioning unit), a catheter junction box, and a laser printer. The system may also be configured with an integrated EP-4 clinical stimulator and touch-screen computer monitor (cleared in K040207).

The EP-WorkMate 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, and transmitted to the amplifier, which amplifies and conditions the signals before they are received by the EP-WorkMate computer for measurement and display.

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 multiple channels on a beat-by-beat basis and dynamically displayed on the real-time display. Menu-driven software is utilized for data acquisition and analysis, interval posting, and instant data retrieval with waveform markers and intervals displayed.

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 realtime 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,

This 510(k) summary does not contain information typically found in a study proving a device meets acceptance criteria, especially for AI/ML-driven devices. This is a submission for an electrophysiology recording and monitoring system, which as described, appears to be a hardware and software system for acquiring, displaying, and storing physiological signals, rather than an AI/ML diagnostic tool.

The document states that "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." This indicates an engineering validation approach rather than a clinical study with acceptance criteria for diagnostic performance.

Given the provided text, I cannot extract answers for many of your questions, as they pertain to clinical studies, AI performance metrics, and expert adjudication, which are not detailed in this submission.

Here's what I can infer from the provided text, addressing your questions where possible:

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

The document does not explicitly state acceptance criteria in a quantitative, performance-based manner typical for diagnostic device efficacy (e.g., sensitivity, specificity, accuracy). Instead, it states that "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." This implies acceptance related to meeting engineering specifications and maintaining safety and effectiveness attributes similar to the predicate device.

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

Not applicable or not provided. The bench testing performed would likely involve hardware and software validation testing, not a clinical test set with patient data provenance.

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)

Not applicable or not provided. Ground truth establishment by experts is typically relevant for diagnostic AI/ML devices or clinical studies with human interpretation, which is not described here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable or not provided.

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 device is not described as an AI assistance tool for human readers in a diagnostic context.

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

Not applicable. The description is of a system that acquires and displays signals for human interpretation, not an algorithm providing a standalone diagnostic output.

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

Not applicable or not provided. For "bench testing," ground truth would likely be based on known signal inputs or predefined engineering specifications rather than clinical outcomes or expert consensus.

8. The sample size for the training set

Not applicable. The device is not described as an AI/ML model requiring a training set in the conventional sense.

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

Not applicable.

Summary of what is known about the "study":

• Type of Study: Bench testing.
• Purpose: To confirm that changes in the device met design requirements and did not affect the safety or effectiveness of the product.
• Methodology: The development was performed in accordance with St. Jude Medical's Quality System requirements and in compliance with Quality System Regulation design control requirements (21 CFR 820.30). A Declaration of Conformity with Design Controls was provided.
• Conclusion: Performance testing demonstrated that any operational and performance differences from the predicate device do not adversely affect the device's safety and effectiveness, leading to a substantial equivalence determination.

Ask a specific question about this device

The EP-WorkMate® is intended to be used with an EP-3 [K935590] or EP-4 {K0401442] stimulator for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias measurements of electrical conduction.

NurseMate™ with Physio Module is indicated for use during clinical electrophysiology procedures.

NurseMate™ with Physio Module is a simple modification to EP-WorkMate® with NurseMate™ that allows data from an OEM (Original Equipment Manufacturer) physiologic monitoring device (connected to NurseMate™) to be logged into the current EP-WorkMate® database. The benefit of this product is reduced manual data entry and improved data management. NurseMate™ with Physio Module PC workstation is connected to the EP-WorkMate® system; it may also be connected to an OEM physiologic monitor. Interconnection of NurseMate™ with Physio Module to a physiologic monitor is accomplished using a serial data cable. Use of an OEM physiologic monitoring device is not affected in any way by integration with NurseMate™; users follow the monitor's IFU and operate the device in accordance with its intended use.

Here's a breakdown of the acceptance criteria and study information for the NurseMate™ with Physio Module based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a modification to an existing device (EP-WorkMate®) called NurseMate™ with Physio Module. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results with specific acceptance criteria and performance metrics in the way a PMA submission might.

Therefore, the "acceptance criteria" here are implicitly related to demonstrating that the modified device does not raise new questions of safety and effectiveness and performs as intended without adverse effects on patient care or data integrity. The performance reported is primarily functional.

• EP-WorkMate® (PC) to NurseMate™ (PC) connection: client-server operation, CAT 5 networking cable, TCP/IP protocol. NurseMate™ can issue start/stop recording commands to WorkMate®.
• NurseMate™ (PC) to EP-WorkMate® (Amp/SCU) connection: LAN connection hardware, Packet Driver protocol for viewing real-time EP waveforms.
• NurseMate™ (PC) to OEM Physiologic Monitor: standard serial cable, DB-9 to USB connectors, basic serial data communications protocol.
  The system is designed to allow independent charting and monitoring by a nurse while the physician controls the EP study. |
  | 3. Safety & Control: NurseMate™ with Physio Module does not interfere with the control or primary functions of the EP-WorkMate® or the OEM physiologic monitor. | "NurseMate™ with Physio Module does not control the patient monitor and it does not control cardiac stimulation."
  "NurseMate™ with Physio Module controls only start/stop recording in the EP-WorkMate®; it does not control any aspect of other devices interconnected with the EP-WorkMate®."
  "NurseMate™ with Physio Module does not control the OEM physiologic monitor in any way. NurseMate™ with Physio Module has no alarms or real time physiologic data display; these functions remain separately resident on the physiologic monitor."
  "Use of an OEM physiologic monitoring device is not affected in any way by integration with NurseMate™; users follow the monitor's IFU and operate the device in accordance with its intended use." |
  | 4. Maintenance of Intended Use: The device retains the intended diagnostic use of the predicate EP-WorkMate®. | The Indications for Use for NurseMate™ with Physio Module remains "indicated for use during clinical electrophysiology procedures," consistent with the original EP-WorkMate®. The modification is presented as an enhancement to workflow and data management rather than a change in diagnostic function. |
  | 5. Software and Hardware Equivalence: Software and hardware modifications are appropriately implemented and do not introduce new risks. | Software: "modified version of the EP-WorkMate® with NurseMate™ application software," using the same Microsoft Visual C++ 6.0 Integrated Development Environment. Program code was added, indicating high similarity.
  Hardware: "identical to that of the original NurseMate™ system; these were designed and built using similar PC technology employed in the EP-WorkMate®." Comprises standard PC components. |

Study Information:

This 510(k) summary describes a modification to an existing device, and the documentation provided does not detail a clinical study in the traditional sense (e.g., patient trials with statistically significant outcomes). Instead, it focuses on the design controls, verification, and validation processes used in integrating physiologic monitors with NurseMate™ with Physio Module to ensure the functional requirements outlined above are met and that the device remains substantially equivalent to its predicate.

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

   • Not explicitly stated. The document refers to "design controls, verification and validation processes in the integration of physiologic monitors." This implies internal testing and validation of the software and hardware interfaces. No specific patient data test set or its provenance is mentioned as this device is an IT infrastructure modification for data handling, not a new diagnostic algorithm.

2. 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):

   • Not applicable/not stated. As there isn't a specific diagnostic "ground truth" establishment in the context of a clinical study, this information is not provided. The "ground truth" for this type of submission would relate to the correct function and data integrity of the system during its operation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/not stated. Adjudication methods are typically used when there's a subjective assessment involved (e.g., image interpretation). This submission focuses on the functional performance and data integrity of a monitoring system interface, which would be verified through technical testing rather than expert adjudication of clinical outcomes.

4. 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:

   • No. An MRMC study is not mentioned as this device is not an AI-powered diagnostic tool, but rather a system for data capture and display that integrates with existing diagnostic equipment.

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

   • This is not an AI algorithm. The performance is assessed based on the correct functionality of the software and hardware interfaces within the broader clinical workflow. The device does not operate in a standalone diagnostic capacity.

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

   • The "ground truth" in this context would be the accurate and reliable transfer/logging of data from the OEM physiologic monitor to the EP-WorkMate® database, as well as the correct display of EP waveforms and the ability to initiate/stop recording. This would be established through technical verification and validation testing against specified functional requirements, likely involving engineering and clinical experts in system operation and data integrity, rather than a clinical ground truth like pathology.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. See above.

Ask a specific question about this device

The EP-WorkMate® with an EP-3 (K935590) or EP-4 (K041442) stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias measurements of electrical conduction. The addition of NurseMate™ does not change intended use of the EP-WorkMate®.
Indications for Use Statement
EP-WorkMate® is indicated for use during clinical electrophysiology procedures. The addition of NurseMate™ does not change the indications for use.
NurseMateTM is indicated for use during clinical electrophysiology procedures.

This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used for real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies.

The provided 510(k) summary for K063113 describes the NurseMate™, a modification to the EP-WorkMate® system. This document is focused on demonstrating substantial equivalence to a predicate device (EP-WorkMate® K994011) rather than a de novo submission. As such, the study described is primarily a comparison of functionalities and specifications to show that the new device, NurseMate™, does not introduce new safety or effectiveness concerns.

Therefore, the typical acceptance criteria and detailed study design (sample size, ground truth, expert adjudication, MRMC, standalone performance) that would be expected for a de novo submission or a device with new clinical claims are not explicitly present or elaborated upon in this 510(k) summary. The summary emphasizes that the addition of NurseMate™ does not change the intended use or indications for use of the EP-WorkMate®.

Summary of Information based on K063113:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification to an existing device (EP-WorkMate®) and the claim is that the NurseMate™ does not change intended use, the "acceptance criteria" revolve around demonstrating that the new functionalities of NurseMate™ do not negatively impact the safety and effectiveness established for the predicate device. The performance reported is primarily functional comparison.

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

• Not explicitly stated. The document describes the system's function and a functional comparison. It doesn't detail a specific "test set" in terms of subject data for performance claims. The comparison is primarily against the established functionalities and components of the predicate EP-WorkMate®.

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

• Not applicable / Not explicitly stated. This type of information is typically required for studies demonstrating clinical diagnostic accuracy through expert interpretation of medical images or data. For a functional modification to a diagnostic computer that maintains its original intended use, expert-established ground truth on a test set is not detailed in this 510(k) summary. The demonstration relies on functional validation and comparison to the predicate.

4. Adjudication method for the test set

• Not applicable / Not explicitly stated. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. An MRMC study is not mentioned. Such studies are typically performed to assess the impact of AI on human reader performance for diagnostic tasks, which is not the primary claim of this submission. The NurseMate™ acts as an additional workstation for charting and monitoring, not as a diagnostic aid that enhances physician interpretation in an MRMC context.

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

• Implicitly, "yes," in terms of functional validation. The NurseMate™ software (modified EP-WorkMate® application) and hardware components are described as functioning independently as a workstation, receiving data and allowing input. However, "standalone performance" in the context of diagnostic accuracy (e.g., sensitivity/specificity) is not applicable as the NurseMate™ is not an independent diagnostic algorithm. Its function is to display data and record charting information, with the diagnostic function residing with the physician and the main EP-WorkMate® system. The key functional performance described is its ability to display accurate physiological data and to record patient charting information without error.

7. The type of ground truth used

• Functional Specification/Predicate Device Comparison. The "ground truth" for this submission are the functional specifications of the NurseMate™ and the established performance of the predicate EP-WorkMate®. The NurseMate™ is intended to accurately display data transmitted from the Amp/SCU and the EP-WorkMate®, and to accurately record user input as patient charting data on the EP-WorkMate®. The ground truth for this would be that the displayed data matches the source data, and the recorded data matches the input data, both validated through internal testing and verification activities against the device's design specifications.

8. The sample size for the training set

• Not applicable / Not explicitly stated. There is no mention of a "training set" in the context of machine learning or AI models, as this device is a software modification and hardware addition for data display and charting, not a learning algorithm.

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

• Not applicable. See point 8.

Ask a specific question about this device

The EP-WorkMate® with RPM™ System is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhyrhmia mapping.

Not Found

The provided document is a 510(k) premarket notification clearance letter for the EP-WorkMate® with RPM™ Mapping System, dated August 2, 2003. This type of document indicates substantial equivalence to a predicate device and does not typically include detailed acceptance criteria or extensive study results in the format requested. The letter focuses on regulatory clearance, not detailed performance metrics.

However, based only on the information provided in this document, here's what can be extracted, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the clearance letter. Regulatory clearance letters confirm substantial equivalence to a predicate device, but they do not typically detail the specific acceptance criteria or the specific device performance values as determined by studies submitted to the FDA.

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

This information is not provided in the clearance letter.

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

This information is not provided in the clearance letter.

4. Adjudication method for the test set:

This information is not provided in the clearance letter.

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 clearance letter. The device is described as an "EP-WorkMate® with RPM™ Mapping System," which is a "Programmable diagnostic computer" for "diagnostic electrical stimulation of the heart." This suggests the device is used for electrophysiology (EP) studies and mapping, not necessarily an AI-powered image analysis tool that would typically involve a multi-reader study of human interpretation improvement.

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

This information is not provided in the clearance letter. Given the nature of a "diagnostic computer" for EP procedures, it's highly likely that it's intended to be used with human operators (electrophysiologists).

7. The type of ground truth used:

This information is not provided in the clearance letter.

8. The sample size for the training set:

This information is not provided in the clearance letter.

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

This information is not provided in the clearance letter.

Summary based on the provided document:

The document is an FDA 510(k) clearance letter confirming that the EP-WorkMate® with RPM™ Mapping System is "substantially equivalent" to legally marketed predicate devices. It states the "Indication for Use" is "for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping."

The letter does not include details about specific performance metrics, acceptance criteria, study designs (like sample sizes, expert qualifications, adjudication methods), or ground truth establishment for either training or test sets. Such granular information is typically found in the 510(k) submission itself or related study publications, not in the clearance letter.

Ask a specific question about this device

The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding 510(k) clearance for a device named "EP WorkMate Computerized Electrophysiology Recording System". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

However, this document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe these aspects of a study.

Ask a specific question about this device