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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.

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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.

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