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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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Change Healthcare Cardiology Hemodynamics™ is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment. Change Healthcare Cardiology Hemodynamics™ is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

Change Healthcare Cardiology Hemodynamics™ is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other patient/procedural data management is needed.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses.

Use of the system is not intended patient monitoring or in situations where arrhythmia detection is required.

The Change Healthcare Cardiology Hemodynamics™ device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the area of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.

Change Healthcare Cardiology Hemodynamics™ also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates interfacing with hospital information systems and cardiac image management, archiving and reporting systems.

Change Healthcare Cardiology Hemodynamics™ incorporates the Argus PB-3000 vital signs monitoring device (K221056), manufactured by Schiller AG, which provides patient monitoring via:

• ECG leads
• Invasive Blood Pressure (connected to non-Change Healthcare transducers)
• SpO2 finger clip
• Non-invasive blood pressure (NIBP) cuff
• Temperature probe
• Thermal Dilution Cardiac output temperature probe (connected to non-Change Healthcare Cardiac Output catheter)
• CO2 (connected to non-Change Healthcare cannulas or intubation tubes)
  Argus PB-3000 monitoring device is provided with compatible accessories (cables, sensors, cuffs, probes, etc). Appendix L of the Change Healthcare Cardiology Hemodynamics User Guide includes a List of qualified PB-3000 accessories.

Change Healthcare Cardiology Hemodynamics™ is composed of:

• A control and documentation unit (Information System) that is used for administration, performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data.
• A Clinical System that incorporates the RT Monitor and the Front-end (which incorporates the Schiller Argus PB-3000 device). The clinical system is responsible for acquiring, analyzing, and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors.

Change Healthcare Cardiology Hemodynamics™ uses an interface that displays patient data, procedure data, waveforms, and numeric values. The performing physician views the monitor, and conveys instructions and procedure notes to the technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience.

The control and documentation unit (Information System) can function independently from the Clinical unit and therefore can be setup without the clinical unit for instances where only patient/procedure documentation is required.

In addition, the Change Healthcare Cardiology Hemodynamics™ system can receive and/or export data from 3rd party devices and systems. One such utilization is the ability to import monitored parameter data from 3rd party bedside monitors for documentation purposes as part of the patient's log (part of the Holding Area Charting configuration). This import is performed via the utilization of FDA cleared Capsule's SmartLinx software (K200856) that is intended for clinical information management through networks with independent devices.

Physicians can instruct the technician to configure the appearance, content and layout of the display on the monitors that display the patient's vitals and other pertinent clinical data (real-time monitors) and to perform real-time functions and measurements using the tools that exist in the control and documentation unit. This pane can be shown or hidden at any time by clicking Procedure Control in the display control bar. Each pane in the real-time controls area can be expanded to show more content and contracted to save space when that content is not needed. Changes should be made only upon request or instruction of the physician.

The clinical system resides on a dedicated computer to ensure that it is not vulnerable to failure of the network or the backend computer on which the application resides. In case of application failure, the system knows how to restart itself and restore a stable OS environment on the computer. Watchdogs are in place to prevent failure.

This document is a 510(k) Pre-market Notification from the FDA, asserting that the Change Healthcare Cardiology Hemodynamics™ device is substantially equivalent to a previously cleared predicate device. Therefore, a full clinical study to prove the device meets acceptance criteria was not performed or required as part of this submission.

Here's a breakdown based on the provided document, addressing the points where information is available or explicitly stated as not applicable:

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

The document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical trial for a new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Change Healthcare / McKesson Cardiology Hemo™, K131497) through non-clinical testing and comparison of technological characteristics.

The "acceptance criteria" here are implicitly the successful completion of the listed non-clinical tests and the demonstration that the new device's changes (e.g., updated vital signs acquisition unit, software, alarms) preserve its safety and effectiveness and do not raise new questions of safety or effectiveness compared to the predicate.

The reported "performance" is the device functioning as intended in the non-clinical tests and demonstrating identical or substantially equivalent features to the predicate.

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

This document describes a 510(k) submission, relying primarily on non-clinical performance data and comparison to a predicate device. Therefore, the concept of a "test set" with "data provenance" (like in a clinical study) as commonly understood for AI/ML device validation is not directly applicable here.

• Test Set Sample Size: Not applicable in the context of an AI/ML clinical study test set. The validation was against engineering specifications, simulated data (where applicable for non-clinical testing of the vital signs unit or software functionality), and comparison to the predicate.
• Data Provenance: Not applicable. The testing described (electrical safety, EMC, software V&V) is typically done in laboratory or simulated environments, not with patient data.

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

Not applicable. The submission did not involve clinical image interpretation or data labeling by experts for a test set to establish ground truth because it is not an AI/ML diagnostic or prognostic device that relies on such interpretation. The "ground truth" for non-clinical tests would be the established engineering specifications and performance standards.

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

Not applicable, as there was no clinical image interpretation test set requiring adjudication.

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 study was done. The document explicitly states: "No clinical testing was necessary to support substantial equivalence." This device is a hemodynamic monitoring system, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.

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

This is not an AI/ML algorithm with "standalone" performance. The device is a physiological/hemodynamic monitoring system incorporating hardware and software, designed to be operated by a human technician and used under the direction of a physician. Its performance is inherent in its operation and data acquisition, not as an algorithm generating a diagnostic output on its own.

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

For a device like this, the "ground truth" generally refers to:

• Engineering specifications and regulatory standards: The device's components (e.g., vital signs acquisition unit, software modules) are expected to perform according to predefined technical specifications and comply with relevant international standards (e.g., IEC 60601 series for electrical safety, ISO standards for specific physiological measurements, IEC 62304 for software lifecycle processes).
• Predicate device performance: The performance of the new device relative to the legally marketed predicate device is the primary "ground truth" for demonstrating substantial equivalence.

No clinical expert consensus, pathology, or outcomes data were used to establish ground truth for this 510(k) submission as no clinical study was performed.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model trained on a "training set" of data.

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

Not applicable for the same reason as above.

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