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Merge Hemo displays, measures, and records physiological data from patients undergoing invasive catheter-based diagnostic and interventional procedures.

The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCQ2 waveforms. The system can also perform specified calculations from captured or manually entered values.

The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC.

All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses.

Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third-party database, the Hemo system can display drug or drug-to-allergy interaction information.

The Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.

The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.

The device consists of off-the-shelf computer hardware such as personal computers and servers, a Patient Data Module (PDM) that acquires patient vitals received from accessories such as ECG electrodes, invasive catheters/pressure transducers, and temperature probes, and transmits them to the Merge Hemo Monitor.

The Merge Hemo system includes a Record Station with options to add a Procedure Room Hemo Monitor or a Remote Operators Terminal (ROT). The Record Station Workstation for Merge Hemo, Model RCSV2 is made up of medical grade Hemo Client and Hemo Monitor All-in-One computers with built-in display monitors.

The new PDM component, the ARGUS PB-3000 manufactured by Schiller AG, acquires the following patient vitals: ECG, Invasive Blood Pressure, SpO2, Non-Invasive Blood Pressure, Temperature, Cardiac Output, and CO2, digitizes the signals, and transmits them to the Hemo Monitor in the Record Station. The Client side of the Record Station is responsible for the documentation, display, storage, and distribution of the data acquired during the procedure.

The provided text does not contain typical acceptance criteria and a study proving device performance as might be found in a clinical trial summary. Instead, it describes a 510(k) premarket notification for a medical device (Merge Hemo, Model RCSV2) and outlines the regulatory process and the types of non-clinical performance data submitted to demonstrate substantial equivalence to a predicate device.

The "acceptance criteria" here refer to compliance with various electrical safety, electromagnetic compatibility, usability, and software development standards, rather than specific performance metrics like sensitivity or specificity for a diagnostic device. The "study" is a compilation of non-clinical tests demonstrating adherence to these standards.

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in terms of patient data for evaluating diagnostic performance. The testing described is primarily non-clinical, focusing on hardware and software compliance with regulatory standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable/provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided as no clinical ground truth establishment using experts is described for diagnostic performance evaluation. The "ground truth" for the non-clinical tests would be the specifications and requirements of the various standards the device is tested against.

4. Adjudication Method

This information is not applicable/provided as no clinical study requiring adjudication of expert interpretations is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The application is for a hemodynamic monitoring system, not a diagnostic imaging AI system that typically undergoes MRMC studies. The document states: "Clinical testing was not required to demonstrate the safety and effectiveness of Merge Hemo, Model RCSV2." Therefore, the effect size of human readers with/without AI assistance is not applicable/provided.

6. Standalone (Algorithm Only) Performance Study

The document describes the device as a "hemodynamics recording computer system" and lists various vital parameters it monitors, measures, displays, and records. It also mentions "specified calculations from captured or manually entered values" and "same software algorithms" for physiological parameters.

While software verification and validation are mentioned, there is no separate "standalone performance study" of an algorithm without human involvement in the sense of a diagnostic AI product. The system is designed to acquire and display physiological data for qualified medical personnel to use in diagnosis and treatment. The performance evaluation focuses on the system's ability to accurately acquire, process, and display data in compliance with medical device standards, rather than an autonomous diagnostic algorithm's accuracy.

7. Type of Ground Truth Used

The "ground truth" for the described performance evaluation (electrical safety, EMC, software V&V, usability) is the requirements and specifications outlined in the applicable international and national standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). The device is tested to ensure it operates within the defined limits and behaviors stipulated by these standards.

8. Sample Size for the Training Set

This information is not applicable/provided. As explained, the "study" is a non-clinical evaluation of compliance with regulatory standards, not a machine learning model training and testing process involving patient data in the typical sense for AI/ML devices.

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

This information is not applicable/provided for the reason stated above.

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Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure.

The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, non-invasive blood pressure (NIBP). Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveform.

The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface.

All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via the serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions.

Patient allergies and current medication information can be entered by the system. If desired and using a third party database the Hemo system can display drug to allergy interaction information.

The system is intended for use in hospital catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.

Merge Hemo is a hemodynamic recording and display system designed to measure, record, and display vitals signs data for patients undergoing cardiac catheterization procedures.

The addition of a Merge Hemo software feature that provides the ability to calculate and display Fractional Flow Reserve (FFR) values is described. No hardware changes are required in order to enable or perform this functionality.

FFR provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization.

FFR measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.

The Merge Hemo software user interface displays the pressure waveforms from the third party FFR pressure transducers that are placed distal and proximal to the lesion. When the FFR feature is enabled, the system shows the section of each of the waveforms that is used to calculate the mean pressure.

The results of the pressure waveform recording is expressed as a fraction of the normal blood flow in the coronary artery compared to the maximum achievable blood flow in the same artery. An FFR measurement of 1.0 indicates an artery with normal blood flow. FFR measurements less than 0.80 indicate that ischemia could be caused by blood flow blockage.

The Merge Hemo software initially selects segments of the waveforms to use for FFR calculations but the user can easily change where the values are taken by using the touchscreen interface to move the segment markers along the waveforms. The FFR value recalculates accordingly.

Here's a breakdown of the acceptance criteria and study information for the Merge Hemo device based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it describes the performance objective of the FFR calculation and the results of the key comparison study.

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

• Sample Size: The document does not specify a numerical sample size for the test set used in the "Integration Test: Comparison of Merge Hemo System vs. ACIST FFR System" or the "Integration Test: Compatibility of Different FFR Pressure Transducers." It refers to "varying the input pressure values" for the physiologic simulator test and "various makes and models" for the compatibility tests without quantifying the number of data points or instances.
• Data Provenance: The data was generated through in-house bench testing using physiologic simulators and commercially available third-party FFR pressure measurement devices and standard pressure transducers. No patient data (retrospective or prospective) was used for these specific tests according to the document.

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

There were no experts utilized to establish the ground truth for the test set for the FFR calculation. The ground truth was established by:

• The known input values from physiologic simulators.
• The output from a legally marketed predicate FFR system (ACIST RXi Rapid Exchange FFR System, K132474), which was used as the reference standard for comparison.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process described. The comparison was against known values or a predicate device's output.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were required in order to demonstrate the proper integration of the measurements into Merge Hemo for the calculation of FFR values."

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

Yes, a standalone performance evaluation was conducted. The tests described ("Physiologic Simulator Test," "Integration Test: Comparison of Merge Hemo System vs. ACIST FFR System," and "Integration Test: Compatibility of Different FFR Pressure Transducers") evaluate the algorithm's calculation and compatibility purely based on its output compared to a reference, without human interaction influencing the FFR calculation itself after the pressure inputs are provided. The user can move segment markers to re-calculate FFR, but the calculation itself is algorithmic.

7. The Type of Ground Truth Used

The ground truth used was:

• Known values from physiologic simulators (for the "Physiologic Simulator Test").
• Comparison against a predicate device's output (ACIST RXi Rapid Exchange FFR System) for the FFR calculation, which itself is a cleared medical device and serves as a de-facto "expert consensus" or established standard in this context.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This suggests that the FFR calculation feature might not rely on machine learning models that require a separate training set. The description of FFR ("The calculation of the FFR ratio is relatively simple and is well known...") implies a deterministic, algorithm-based calculation rather than a learned model.

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

Since no training set information is provided, this question is not applicable.

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