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The intended use of the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision) is the acquisition, amplification, display, recording, and transmission of electrical signals of biological origin obtained during electrophysiology studies and related procedures. Such signals include ECG, intracardiac ECG, and blood pressure. Physiological parameters as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from these signals and displayed numerically, recorded, and/or transmitted.

Additionally, the EPXpress System (Timberwolf Revision) may acquire, transpose, amplify, display, record and transmit measurement data received from other medical devices typically used during these procedures, such as oximeters, RF generators, or electronic thermometers.

The EPXpress System (Timberwolf Revision) is an integrated catheter switching amplification and display system that can be installed at the patient table in the electrophysiology lab or moved to other locations where particular procedures may require its use. The system is made up of the EPAmp, Real-Time Controller, and monitor that are usually mounted on a cart. The EPAmp unit amplifies and conditions electrical signals from intracardiac catheters and displays these signals on a real-time monitor and/or prints these results to a chart recorder. The Timberwolf Revision added the capability of numerically displaying diastolic, systolic and mean blood pressures, as well as heart rate, cycle length, and certain measurement data received from other instruments.

Here's a summary of the acceptance criteria and study details for the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria were initially stated as "+/- 2 mmHg," but the conclusion references a "+/- 5% equivalence region." This suggests that the final assessment of equivalence was made using the 5% equivalence region, and the device met this criterion. If the intent was for both to be met, the documentation is slightly ambiguous, but it explicitly states the device met equivalence using the 5% region.

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

• Sample Size: Not explicitly stated as a number of measurements. The study used "measurement values... selected from the range of available, pre-set values provided by a simulator" and applied various dynamic IVBP waveforms (left ventricular, aortic, left arterial, pulmonary capillary wedge, and pulmonary arterial waveforms). This suggests a variety of data points were generated but not a specific count.
• Data Provenance: The data was generated through a controlled, repeatable simulated input using a simulator. This is prospective data, as it was generated specifically for the testing. The country of origin is not explicitly stated for the simulated data, but the submitter is from Canada.

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

• Number of Experts: Not applicable. The ground truth was established by a "simulator" which provided "pre-set values." This is a technical, engineered ground truth rather than expert-derived.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The ground truth was established by direct output from a simulator, eliminating the need for human adjudication of the ground truth. The comparison was a direct measurement comparison between the test device and the predicate device's measurements against the simulator's known values.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focused on the equivalence of a physiological monitoring system's blood pressure measurement capabilities, not an AI-assisted diagnostic or interpretative system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, this was effectively a standalone performance study. The "EPXpress System (Timberwolf Revision)" was compared directly against a predicate device using simulated inputs. The performance being evaluated was the device's ability to measure and display blood pressure, which is an algorithmic/hardware function without human interpretation in the loop for the core measurement task.

7. The Type of Ground Truth Used:

• Ground Truth Type: Simulator-generated, pre-set values. This can be categorized as a type of technical/device-generated ground truth or known input ground truth, where the simulator provided the reference standard.

8. The Sample Size for the Training Set:

• Not applicable. The EPXpress System (Timberwolf Revision) is a physiological monitoring system, not an AI/machine learning device that requires a training set. Its "capabilities" are built through hardware and software design rather than learned from data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there was no training set.

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