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The EP-NurseMate™ and the EP-NurseMate™ with Physio Module, Version 4.2.0, are modifications to the EP-WorkMate TM Recording System. The EP-NurseMate is connected to the EP-WorkMate Recording System for real-time charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies. Expanding the EP-WorkMate™ Recording System with the optional EP-NurseMate™ or EP-NurseMate™ with Physio Module creates an additional workstation for a member of the EP team to perform charting (e.g., event titles, medications, and comments) and monitor physiologic data from their own display.

AI/ML Overview

This document describes the EP-NurseMate and EP-NurseMate with Physio Module, software and hardware modifications to the EP-WorkMate Recording System, for use during clinical electrophysiology procedures.

Here's an analysis of the provided text in response to your request:

Acceptance Criteria and Device Performance Study

The document provided does not contain a specific table of acceptance criteria or a detailed "study" to prove the device meets these criteria in the traditional sense of a clinical trial with statistical endpoints for performance metrics like sensitivity, specificity, or reader agreement.

Instead, this 510(k) submission focuses on substantial equivalence to a predicate device. The core argument is that the modifications (EP-NurseMate and EP-NurseMate with Physio Module) do not change the indications for use, fundamental scientific technology, or adversely affect the safety or effectiveness compared to the already cleared predicate device (NurseMate and NurseMate with Physio Module).

Therefore, the "acceptance criteria" and "study" are described more in terms of design control verification and validation activities and qualitative arguments of equivalence rather than quantitative performance metrics of a diagnostic algorithm or new therapeutic device.

Here's an attempt to structure the information based on your request, acknowledging the limitations of what's provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance and Confirmation
Functional Equivalence: The modified device (EP-NurseMate/-Physio) performs the intended functions (viewing/measurements of cardiac electrograms, electronic data entry, receiving vital signs for Physio module) without adverse impact compared to the predicate.	Confirmed: The EP-NurseMate and EP-NurseMate with Physio Module are described as "an extension of the EP-WorkMate™ Recording System" creating "an additional workstation for a member of the EP team to perform charting (e.g., event titles, medications, and comments) and monitor physiologic data from their own display." This implies functional equivalence to the predicate's purpose of providing remote review and charting. The software is a "modified version of the EP-WorkMate™ application software," and "modifications... did not adversely affect the safety or efficacy of the devices."
Safety: The modified device does not introduce new safety concerns or increase existing risks.	Confirmed: "modifications... did not adversely affect the safety or efficacy of the devices." It's explicitly stated that "NurseMate™/EP-NurseMate™ with Physio Module do not control the patient monitor and do not control cardiac stimulation," which are critical safety-related functions.
Effectiveness/Efficacy: The modified device maintains the efficacy of the predicate device for its intended use.	Confirmed: "modifications... did not adversely affect the safety or efficacy of the devices." The conclusion states, "Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness." The device has "the same indications for use and fundamental scientific technology as the predicate devices."
Compliance with Design Control Requirements: Development followed regulatory standards.	Confirmed: "The development of the EP-NurseMate™ and the EP-NurseMate™ with Physio Module were performed in accordance with St. Jude Medical's Quality System requirements, and in compliance with Quality System Regulation design control requirements documented in 21 CFR 820.30. A Declaration of Conformity with Design Controls is provided in Attachment J."
Substantial Equivalence: The device is substantially equivalent to the predicate device.	Confirmed: This is the ultimate conclusion of the submission. "The EP-NurseMate™ and the EP-NurseMate™ with Physio Module have the same indications for use and fundamental scientific technology as the predicate devices. All technological characteristics of the EP-WorkMate are substantially equivalent to the predicate device."

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

Sample Size: Not explicitly stated as a number of "cases" or "patients." The testing method described is "Clinical simulation testing." This likely involved testing the software and hardware functions in a simulated environment, possibly with a defined set of test scenarios or test data, but the quantity of these is not specified.
Data Provenance: Not applicable in the context of clinical data for a performance study. "Clinical simulation testing" usually implies internally generated data or testing environments, not real-world patient data (retrospective or prospective). The country of origin of this simulated testing is implied to be within St. Jude Medical's development and testing facilities (West Berlin, NJ, USA).

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

This type of information is not present. "Clinical simulation testing" would typically involve engineers and possibly clinical domain experts (e.g., EP nurses, cardiologists) to verify functionality, but not to establish "ground truth" in the sense of diagnostic medical imaging or algorithm performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. As there is no "ground truth" established by multiple experts in a diagnostic context, there is no adjudication method described.

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, an MRMC comparative effectiveness study was not conducted. This device is not an AI diagnostic tool designed to assist human readers in interpretation or improve their performance. It is a charting and monitoring workstation.

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

Not applicable. This device is not an "algorithm only" device for standalone performance evaluation in the usual sense (e.g., classifying images). It is an interactive workstation that supports human users in clinical procedures. The "software" functions are described as "menu driven" and controlled by a user interface.

7. The type of ground truth used

For the "clinical simulation testing," the "ground truth" would be the expected functional behavior and output of the system according to its design specifications. This is derived from design requirements and specifications, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device submission describes software modifications and hardware integration for a medical workstation, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for an AI algorithm.

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