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HemoSphere Alta™ Advanced Monitor with Swan-Ganz Technology
The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and petical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed in a hospital environment. Refer to the Edwards Swan-Ganz Ir catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.

HemoSphere Alta Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric 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.

HemoSphere Alta Advanced Monitor with HemoSphere Pressure Cable or HemoSphere Alta Monitor Pressure Cable
The HemoSphere Alta monitor when used with the HemoSphere Pressure Cable or HemoSphere Alta monitor Pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, FloTrac Jr, Acumen IQ, and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.

The Edwards Lifesciences Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

When used in combination with the Swan-Ganz technology connected to a compatible Swan-Ganz catheter, the Edward Lifesciences Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere Pressure Cable connected to a compatible Swan-Ganz catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac a continuous cardiac output and derived parameters.

The Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable or HemoSphere Alta Pressure Cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.

HemoSphere Alta Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor
The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy.

Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions.

Acumen IQ Fluid Meter
The Acumen IQ fluid meter is a sterile single use device that is intended to be used with the HemoSphere Alta AFM cable and AFM software feature to inform the user of the rate of flow. The device is intended to be used by qualified personnel or clinicians in a clinical setting for up to 24 hours.

HemoSphere Alta Advanced Monitor with ForeSight Oximeter Cable
The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight oximeter cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight oximeter cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta monitor.

• When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
· When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
· When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects

The HemoSphere Alta Advanced Monitoring Platform is Edwards' next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates Edwards existing Critical Care technologies into a unified platform.

The Right Ventricular Cardiac Output (RVCO) feature is a machinelearning algorithm that calculates and displays continuous cardiac output (CORV) from the right ventricle using as inputs the right ventricular pressure waveform and derived right ventricular pressure parameters such as SYSRVF, DIARVP, MRVP, RVEDP, PRRV and Max RV dP/dt from the existing Right Ventricular Pressure (RVP) algorithm and if available, intermittent cardiac output (iCO).

The provided text describes the HemoSphere Alta Advanced Monitoring Platform and its various features, as well as the testing conducted to support its 510(k) clearance. However, it does not contain specific acceptance criteria and detailed device performance data in the format of a table, nor does it provide a detailed study that proves the device meets specific acceptance criteria for any of its algorithms.

The document makes general statements about testing, such as:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation."
• "All tests passed."
• "Software verification testing were conducted, and documentation was provided per FDA's Guidance..." "All tests passed."
• "Usability study was conducted per FDA's guidance document... The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."

While it mentions the Right Ventricular Cardiac Output (RVCO) algorithm as a new algorithm and states that "clinical data (waveforms) were collected in support of the design and validation of the RVCO algorithm," it does not present the detailed results of this validation study, nor does it define specific acceptance criteria for the RVCO algorithm and its performance against those criteria.

Therefore,Based on the provided text, I cannot provide the requested information in the form of a table of acceptance criteria and reported device performance for any specific algorithm, nor can I describe a detailed study that proves the device meets these criteria. The document contains general statements about testing and compliance but lacks the specific quantitative data and study design details needed to answer all aspects of your request.

To provide a complete answer, specific study reports and performance data would be required, which are not present in the provided FDA 510(k) summary.

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The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [CO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol 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.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

HemoSphere Alta monitor with HemoSphere Oximetry Cable

The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requring 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.

HemoSphere Alta Monitor with HemoSphere Pressure Cable

The HemoSphere Alta monitor when used with the HemoSphere pressure cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.

The Edwards Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

The HemoSphere Alta™ Advanced Monitoring Platform is Edwards' next-Device generation platform that provides a means to interact with and visualize Description: hemodynamic and volumetric data on a screen. The HemoSphere Alta™ Monitoring Platform provides an improved user interface utilizing the existing Edwards technologies and algorithms commercially available in the HemoSphere Advanced Monitoring Platform.

This FDA 510(k) summary for the Edwards Lifesciences HemoSphere Alta Advanced Monitoring Platform (K232294) primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance validation. It explicitly states that "No new clinical testing was performed in support of the subject 510(k)." As such, the document does not provide specific acceptance criteria for AI/algorithm performance or details of a study proving the device meets such criteria through clinical data.

Instead, the submission emphasizes the device's functional and safety aspects, along with the integration of existing, previously cleared technologies and algorithms into a new hardware and software platform with an improved user interface.

Therefore, many of the requested sections below cannot be fully answered based on the provided text, as the focus was on non-clinical verification and substantial equivalence rather than new clinical performance studies for AI/algorithm features.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific acceptance criteria and detailed device performance metrics for individual AI/algorithm features (like HPI, GHI, AFM, RVP) are not detailed as part of a new clinical study for this 510(k) submission. The submission states, "No new clinical testing was performed in support of the subject 510(k)." The "Performance Data" section primarily discusses non-clinical verification.

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation."
• "System integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing were conducted... All tests passed."

This indicates that internal performance specifications were met, but these specifications themselves are not provided, nor is the performance against them quantified in this public summary.

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

No test set for clinical performance of AI/algorithm features is described, as "No new clinical testing was performed." The device leverages existing, previously cleared algorithms.

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

Not applicable, as no new clinical test set for AI/algorithm performance is described. The AI/algorithm features leverage ground truth established in prior clearances for the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set for AI/algorithm performance is described.

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

No MRMC comparative effectiveness study is mentioned, as "No new clinical testing was performed." The submission focuses on the HemoSphere Alta platform being a new generation integrating existing Edwards technologies and algorithms with an improved user interface and hardware.

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

The document does not describe new standalone performance studies for the AI/algorithm features. The AI/algorithm features (HPI, GHI, AFM, RVP) themselves were likely evaluated in standalone fashion during their original predicate clearances (e.g., K231038 for GHI). This 510(k) integrates these existing algorithms into a new platform.

7. Type of Ground Truth Used

The type of ground truth for the AI/algorithm features (HPI, GHI, AFM, RVP) would have been established during their original clearances. For this 510(k) submission, this information is not provided. Typically, hemodynamic algorithms like HPI or GHI rely on physiological measurements (e.g., direct arterial pressure, SvO2 from Swan-Ganz catheter, outcomes data related to hypotension or hypoperfusion events) as ground truth.

8. Sample Size for the Training Set

No details regarding training set sample sizes for the AI/algorithm features are provided in this 510(k) summary, as it covers the integration of existing algorithms. The training data would have been described in the original 510(k) submissions for those predicate algorithms (e.g., for Acumen HPI feature, Global Hypoperfusion Index, Right Ventricular Pressure algorithm, Acumen Assisted Fluid Management).

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

As with the training set size, the method for establishing ground truth for the training set of the AI/algorithm features is not detailed in this 510(k) summary because it pertains to existing algorithms. This would have been covered in their individual predicate 510(k) submissions.

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