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HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module

The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable

The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatic critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.

The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters.

The HemoSphere Advanced Monitoring Platform is a modular system which uses the same monitoring technology (CCO, ICO, Oximetry), the same associated devices (Swan-Ganz and Oximetry Catheters), the same analog inputs from external vital sign monitors, the same computational algorithms for hemodynamic monitoring and the same default alarm limits as the Vigilance II System (K043103, cleared December 9, 2004). Updates made to the HemoSphere Advanced Monitoring Platform include a modernized look (updated Graphical User Interface (GUI) and touchscreen monitor), wireless capability, a modular architecture for scalability and two new derived oximetry parameters. The updated GUI is similar to the GUI utilized in the EV1000 Clinical Platform (K160552, cleared June 01, 2016). The two new derived oximetry parameters (Estimated Oxygen Consumption (VO2e) and Estimated Oxygen Consumption Index (VO2Ie)) are derived parameters that are currently available on the EV1000 Clinical Platform (K160552, cleared June 01, 2016).

The HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and two optional external modules: the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable.

These optional modules provide an interface to connect with currently cleared and commercially available Edwards Lifesciences Swan-Ganz and Oximetry catheters (K803058, K822350, K905458, K924650, K934742, K940795, K053609 and K110167 and K160884). The modules provide the software technology to compute hemodynamic monitoring data that is then sent to the monitor for visualization and storage.

The HemoSphere Advanced Monitor has an input that can be connected to an external vital sign patient monitor for the purpose of slaving in an analog ECG signal. The HemoSphere Platform uses this analog ECG input signal to calculate a heart rate that is used by the HemoSphere Swan-Ganz Module to calculate certain derived parameters (e.g. HRavg, SV, RVEF and EDV).

The provided text describes the Edwards Lifesciences HemoSphere Advanced Monitor, HemoSphere Swan-ganz Module, and HemoSphere Oximetry Cable. This K163381 submission details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or the study that definitively "proves" the device meets acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, K043103). The performance data section describes verification activities rather than a formal study with predefined acceptance criteria for a new AI/algorithmic performance metric.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text. The document refers to "predetermined design and performance specifications" for the verification activities but does not list them in a table or state specific numerical targets for accuracy, sensitivity, or specificity for the parameters measured by the device.

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

This information is not provided for a test set in the context of an AI/algorithmic performance study. The document mentions "bench simulation" for key parameters, and an "animal study involving 4 pigs." This is not a test set for assessing algorithmic performance in humans.

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

This information is not applicable/provided as no human expert-adjudicated test set for algorithmic performance is described. The "animal study involving 4 pigs and 25 clinicians" was for usability verification, not for establishing ground truth for device measurements.

4. Adjudication Method for the Test Set

This information is not applicable/provided as no human expert-adjudicated test set for algorithmic performance is described.

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

A MRMC comparative effectiveness study was not done or described. The document explicitly states an "animal study involving 4 pigs and 25 clinicians was performed to verify usability of the HemoSphere Advanced Monitoring Platform," which is not an MRMC study comparing human readers with and without AI assistance for diagnostic performance.

6. Standalone Performance Study

While the device's computational algorithms are mentioned as being the same as the predicate device, a standalone (algorithm only without human-in-the-loop) performance study with specific metrics like accuracy, sensitivity, specificity, etc., against a new set of data is not explicitly described. The "System Verification" section mentions testing key parameters using a bench simulation, which implies some form of standalone testing, but specific performance results and acceptance criteria are not detailed.

• Key Cardiac Output parameters (ICO, CCO, RVEF, Blood Temperature and Injectate Temperature) and Oximetry parameters (SvO2 and ScvO2) were tested using a bench simulation. However, the detailed results or acceptance criteria for these tests are not present.

7. Type of Ground Truth Used

For the bench simulation of cardiac output and oximetry parameters, the ground truth would likely be established by the known inputs or reference measurements from the simulation system. For the "usability animal study," the ground truth was related to the device's interaction and functionality as observed by clinicians, not a medical ground truth for diagnosis/measurement accuracy.

8. Sample Size for the Training Set

This information is not provided. The device uses "the same computational algorithms for hemodynamic monitoring" as its predicate device (Vigilance II, K043103). This implies the algorithms were developed and "trained" (if applicable to this type of algorithm) prior to this submission, likely based on data relevant to the predicate device's development. No new training set or training process is described for the HemoSphere platform, as it primarily represents a modernization and feature addition rather than a new core algorithm.

9. How Ground Truth for the Training Set Was Established

This information is not provided, as no new training set is described. For the original algorithms from the predicate device, the ground truth would have been established through methods appropriate for physiological parameter measurement, such as direct measurement using established invasive techniques, reference devices, or controlled experimental conditions in labs or animal studies.

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