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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. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also 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 and Swan-Ganz Jr catheter indications for use statements 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 oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring 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 Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric 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, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards 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 or non-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 Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere 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. The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.

• HemoSphere Advanced Monitor with HemoSphere Technology Module and 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 advanced 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 Advanced Monitor was designed to simplify the customer experience by providing one platform with modular solutions for all hemodynamic monitoring needs. The user can choose from available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

The provided FDA 510(k) clearance letter and summary for the Edwards Lifesciences HemoSphere Advanced Monitor (HEM1) and associated components outlines the device's indications for use and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the specific study results (performance data) in the format typically required to answer your request fully, especially for acceptance criteria and performance of an AI/algorithm-based feature like the Hypotension Prediction Index (HPI) or Assisted Fluid Management (AFM).

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. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing was conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed."

This indicates that internal performance specifications were met, but the specific metrics, thresholds, and study designs for achieving those specifications are not detailed in this public summary.

Therefore, I cannot populate the table with specific numerical performance data against acceptance criteria for the HPI or AFM features, nor can I provide details on sample size, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The text primarily focuses on:

• Substantial equivalence to predicate devices.
• Indications for Use for various HemoSphere configurations and modules.
• Description of software and hardware modifications (e.g., integration of HPI algorithm, new finger cuffs).
• General categories of testing performed (Usability, System Verification, Electrical Safety/EMC, Software Verification) with a blanket statement that "All tests passed."

Based on the provided document, here's what can and cannot be stated:

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

Cannot be provided with specific numerical data or thresholds from the given text. The document only states that "all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." No specific acceptance criteria values (e.g., "Accuracy > X%", "Sensitivity > Y%", "Mean Absolute Error

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Indications for Use: This device is intended for use in patients who are morbidly obese and have failed to lose weight with diet and exercise.

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Here's a breakdown of the acceptance criteria and study details for the Hypertension Prediction Index (HePI) Algorithm, based on the provided FDA 510(k) letter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance is for the overall datasets (N=1813 for Minimally Invasive, N=1351 for Non-invasive). All sub-categories (surgical/non-surgical) also met the acceptance criteria.

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

• Minimally Invasive Sensor:
  • US Patients: 1615 subjects
  • OUS Patients: 198 subjects
  • Total N: 1813 subjects
• Non-Invasive Finger Cuff:
  • US Patients: 464 subjects
  • OUS Patients: 887 subjects
  • Total N: 1351 subjects

Data Provenance: The study used retrospective clinical data from multiple independent datasets. Data was collected from both US and OUS (Outside United States) patients.

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

The provided document does not specify the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method. The ground truth definition of a "hypertensive event" is clearly stated (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg), suggesting an objective, pre-defined criterion rather than expert consensus on individual cases that would require adjudication.

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

The provided document does not indicate that an MRMC comparative effectiveness study was done. The focus is on the standalone performance of the algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The results presented in Table 2 (AUC, Sensitivity, Specificity, PPV, NPV) are direct measures of the algorithm's performance in predicting hypertensive events based on retrospective clinical data, without human interaction.

7. The Type of Ground Truth Used

The ground truth used is defined by objective physiological measurements and thresholds:
A "hypertensive event" is defined as:

• Mean Arterial Pressure (MAP) greater than 115 mmHg for at least 1 minute OR
• A MAP increase of more than 20% when current MAP is greater than 95 mmHg.

8. The Sample Size for the Training Set

The provided document does not explicitly state the sample size for the training set. It mentions that "Algorithm performance was tested using retrospective clinical data" and "Prospective analyses of retrospective clinical data from multiple independent datasets...were analyzed to verify the safety and performance of the subject device," referring to the test sets.

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

The provided document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device and the ground truth definition for the test set, it is highly likely that the same objective physiological measurements and thresholds (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg) were used to establish ground truth labels for the training data.

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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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eCART is a software product that provides automated risk stratification and early warning for impending patient deterioration, signified as the composite outcome of death or ICU transfer. It is intended to be used on hospitalized ward patients 18 years of age or older by trained medical professionals.

As a clinical decision support device, eCART's risk score and trend analysis is intended to aid clinical teams in identifying which patients are most likely to clinically deteriorate. eCART provides additional information and does not replace the standard of care or clinical judgment.

eCART scoring is initiated by the documentation of any vital sign on an adult ward patient. The device calculates risk only from validated EHR data, such as vitals that have been confirmed by a registered nurse (RN); unvalidated data streaming from monitors/devices will not be used until confirmed by a healthcare professional. The product predictions are for reference only and no therapeutic decisions should be made based solely on the eCART scores.

The AgileMD eCARTv5 Clinical Deterioration Suite ("eCART") is a cloud-based software device that is integrated into the electronic health record ("EHR") in order to anticipate clinical deterioration in adult ward patients, which is signified as either of the following two predicted outcomes: (1) death or (2) ICU transfer. The tool synthesizes routine vital signs, laboratory data, and patient demographics into a single value that can be used to flag patients at-risk of the composite outcome of clinical deterioration for additional evaluation and monitoring. eCARTv5 requires the healthcare system within which it will be used, to provide an EHR connection and data interfaces through which the patient data necessary to run the software will be transmitted.

The primary functions of the system are imparted by the Gradient Boosted Machine ("GBM") learning algorithm that takes input directly from the EHR, in real time, to provide an assessment of patients and displays its outputs in an intuitive user interface which drives providers to follow standardized clinical workflows (established by their institutions) for elevated-risk patients.

eCARTv5's end users include med-surg nursing staff, physicians and other providers caring for these patients. The eCARTv5 composite score is determined from the model output (predicted probability of deterioration) scaled from 0-100, based on the specificity (true negative rate). The observed rate of deterioration at each eCART score threshold, displayed as the odds of deterioration in the next 24 hours, is presented to the user along with the scaled score. Default thresholds are set to an eCART of 93 and 97, respectively, for moderate and high risk categorization.

Here's a breakdown of the acceptance criteria and study details for the eCARTv5 Clinical Deterioration Suite, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the eCARTv5 device are implicitly defined by the performance metrics reported in the validation studies, specifically Area Under the Receiver Operating Characteristic curve (AUROC), Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) for two risk thresholds (Moderate-risk at eCART ≥93 and High-risk at eCART ≥97). The composite outcome of interest is "Deterioration" (death or ICU transfer within 24 hours).

Table: Acceptance Criteria (Implicit) and Reported Device Performance

Note: The "Acceptance Criteria (Implicit Target)" values are inferred based on the consistently reported values that demonstrate performance above random chance and clinical utility for risk stratification. The document does not explicitly state pre-defined quantitative acceptance criteria but rather presents the achieved performance as a demonstration of substantial equivalence.

Study Details

1. Sample sizes used for the test set and data provenance:

   • Retrospective Test Set:
     • Encounters (N): 1,769,461 unique hospitalizations.
     • Observations (n): 132,873,833 eCART scores.
     • Unique Patients: 934,454
     • Data Provenance: Admissions between 2009 and 2023 from three geographically distinct health systems. The specific countries are not mentioned, but "US" is inferred from typical FDA submissions. It is retrospective.
   • Prospective Test Set:
     • Encounters (N): 205,946 unique hospitalizations.
     • Observations (n): 21,516,964 eCART scores.
     • Unique Patients: 151,233
     • Data Provenance: Non-overlapping admissions between 2023 and 2024 from the same three healthcare systems as the retrospective analysis. It is prospective.

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

   • The document does not specify the number of experts used or their qualifications for establishing ground truth. The ground truth (death or ICU transfer) appears to be derived directly from Electronic Health Record (EHR) data, which is objective outcome data, rather than requiring expert labeling.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method. Given that the ground truth is death or ICU transfer from EHR, a formal adjudication process involving multiple experts for each case may not have been necessary, as these are typically clear clinical outcomes documented in the EHR.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed to compare human readers with and without AI assistance. The performance data presented is for the standalone algorithm.

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

   • Yes, a standalone study was presented. The performance metrics (AUROC, Sensitivity, Specificity, PPV, NPV) are reported for the eCART algorithm itself, without human intervention in the reported performance. The device is intended as a "clinical decision support device" to "aid clinical teams in identifying which patients are most likely to clinically deteriorate."

6. The type of ground truth used:

   • The ground truth used is outcomes data derived from the Electronic Health Record (EHR). Specifically, "Deterioration is defined as death or ward to ICU transfer within 24 hours following a score." Mortality is defined as "death within 24 hours following a score." These are objective clinical events.

7. The sample size for the training set:

   • The document states: "eCART's algorithm was trained on ward patients..." but does not explicitly provide the sample size of the training set. It only provides details for the retrospective and prospective validation cohorts which are distinct from the training set.

8. How the ground truth for the training set was established:

   • The document does not explicitly detail how the ground truth for the training set was established. However, given the nature of the ground truth for the test set (death or ICU transfer from validated EHR data), it is reasonable to infer that the ground truth for the training set would have been established similarly using objective patient outcomes data from EHRs.

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CLEWICU provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. CLEWICU is intended for use in hospital critical care settings for patients 18 years and over. CLEWICU 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 CLEWICU predictions.

The CLEWICU System is a stand-alone analytical software product that includes the ClewICUServer and the ClewICUnitor. It uses models derived from machine learning to calculate the likelihood of occurrence of certain clinically significant events for patients in hospital critical care settings including:

• Intensive Care Unit (ICU) .
• . Emergency Department's (ED) Critical Care or Resuscitation area
• Post-Anesthesia Care Unit (PACU) .
• . Step-Down Unit
• Post-Surgical Recovery Unit .
• . Other Specialized Care Units (e.g., Cardiac Care Unit (CCU), Neurocritical Care Unit (NCU), High-dependency Care Unit (HDU)
  ClewICUServer and ClewICUnitor are software-only devices that are run on a user-provided server or cloud-infrastructure.
  The ClewICUServer is a backend software platform that imports patient data from various sources including Electronic Health Record (EHR) data and patient monitoring devices through an HL7 data connection. The data are then used by models operating within the ClewICUServer to compute and store the CLEWHI index (likelihood of hemodynamic instability requiring vasopressor / inotrope support), and CLEWLR (indication that the patient is at "low risk" for deterioration).
  The ClewICUnitor is the web-based user interface displaying CLEWHI, and CLEWLR associated notifications and related measures, as well as presenting the overall unit status.

Here is an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The CLEWICU System includes two models: CLEWHI (predicts hemodynamic instability) and CLEWLR (identifies low risk for deterioration).

Note on CLEWLR Specificity (MIMIC): The provided 95% CI for MIMIC Specificity for CLEWLR is stated as (89.1 - 80.9). This appears to be a typo, as the lower bound (89.1%) is higher than the upper bound (80.9%). Assuming the intent was 89.1-90.9 or similar, and given the point estimate is 90% (meeting the target), it is considered to have met the criteria. The text explicitly states "The model validation test results demonstrate that the clinical performance of the CLEWICU models continue to meet the pre-defined acceptance criteria."

Minimum Required Performance Specifications for PCCP (Post-clearance models):

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

• Sample Sizes:
  • UMass dataset: 6534 unique patient stays
  • MIMIC-III dataset: 5069 unique patient stays
• Data Provenance: Retrospective cohort study. The text explicitly states "This was a retrospective cohort study that involved two separate health care systems, each evaluated independently."
  • UMass dataset: From the University of Massachusetts elCU dataset.
  • MIMIC-III dataset: From the MIMIC-III dataset (general knowledge indicates this is a publicly available dataset primarily from Beth Israel Deaconess Medical Center, USA). The country of origin for both is implicitly the USA, as these are US-based datasets/institutions.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It describes the models predicting "hemodynamic instability requiring vasopressor / inotrope support" and "low risk for deterioration," but it doesn't detail how these ground truth labels were derived.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for establishing the ground truth for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses purely on the standalone performance of the algorithm. There is no mention of human readers or AI assistance for human readers, nor any effect size for human improvement.

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

Yes, a standalone study was done. The entire study described focuses on the direct performance of the CLEWHI and CLEWLR models against predefined criteria. The device is a "stand-alone analytical software product."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used appears to be outcomes data based on clinical events. The CLEWHI model predicts "likelihood of occurrence of certain clinically significant events... including hemodynamic instability requiring vasopressor / inotrope support." The CLEWLR model identifies patients at "low risk for deterioration." These are objective clinical outcomes that can be derived from EHRs and patient monitoring data, which are the sources for "patient data from various sources including Electronic Health Record (EHR) data and patient monitoring devices." The document does not mention expert consensus or pathology for ground truth.

8. The Sample Size for the Training Set

The document states that the models were "re-trained using a reduced set of features." However, it does not explicitly state the sample size of the training set(s) used for this re-training. It only provides the sample sizes for the independent test sets (UMass and MIMIC-III). The PCCP section mentions "one dataset for training and a different, completely independent, dataset for testing." This implies a separate training dataset was used, but its size is not given.

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

The document does not explicitly describe how the ground truth for the training set was established. Given the nature of the ground truth for the test sets (clinical outcomes like hemodynamic instability or low risk of deterioration), it can be inferred that the training set's ground truth was established by similar objective clinical event definitions derived from historical patient data (EHR, monitoring devices).

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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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The SignalHF System is intended for use by qualified healthcare professionals (HCP) managing patients over 18 years old who are receiving physiological monitoring for Heart Failure surveillance and implanted with a compatible Cardiac Implantable Electronic Devices (CIED) (i.e., compatible pacemakers, ICDs, and CRTs).

The SignalHF System provides additive information to use in conjunction with standard clinical evaluation.

The SignalHF HF Score is intended to calculate the risk of HF for a patient in the next 30 days.

This System is intended for adjunctive use with other physiological vital signs and patient symptoms and is not intended to independently direct therapy.

SignalHF is a software as medical device (SaMD) that uses a proprietary and validated algorithm, the SignalHF HF Score, to calculate the risk of a future worsening condition related to Heart Failure (HF). The algorithm computes this HF score using data obtained from (i) a diverse set of physiologic measures generated in the patient's remotely accessible pre-existing cardiac implant (activity, atrial burden, heart rate variability, heart rate, heart rate at rest, thoracic impedance (for fluid retention), and premature ventricular contractions per hour), and (ii) his/her available Personal Health Records (demographics). SignalHF provides information regarding the patient's health status (like a patient's stable HF condition) and also provides alerts based on the SignalHF HF evaluation. Based on an alert and a recovery threshold on the SignalHF score established during the learning phase of the algorithm and fixed for all patients, our monitoring system is expected to raise an alert 30 days (on median) before a predicted HF hospitalization event.

SignalHF does not provide a real-time alert. Rather, it is designed to detect chronic worsening of HF status. SignalHF is designed to provide a score linked to the probability of a future decompensated heart failure event specific to each patient. Using this adjunctive information, healthcare professionals can make adjustments for the patient based on their clinical judgement and expertise.

The score and score-based alerts provided through SignalHF can be displayed on any compatible HF monitoring platform, including the Implicity platform. The healthcare professional (HCP) can utilize the SignalHF HF score as adjunct information when monitoring CIED patients with remote monitoring capabilities.

The HCP's decision is not based solely on the device data which serves as adjunct information, but rather on the full clinical and medical picture and record of the patient.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for SignalHF:

Acceptance Criteria and Device Performance for SignalHF

The SignalHF device was evaluated through the FORESEE-HF Study, a non-interventional clinical retrospective study.

1. Table of Acceptance Criteria and Reported Device Performance

For ICD/CRT-D Devices:

For Pacemaker/CRT-P Devices:

2. Sample Size and Data Provenance for the Test Set

• Test Set (Clinical Cohort) Sample Size: 6,740 patients (comprising PM 7,360, ICD 5,642, CRT-D 4,116 and CRT-P 856 - Note: there appears to be a discrepancy in the total sum provided, however, "6,740" is explicitly stated as the 'Clinical cohort' which is the test set).
• Data Provenance: Retrospective study using data from the French national health database "SNDS" (SYSTÈME NATIONAL DES DONNÉES DE SANTÉ) and Implicity proprietary databases. The follow-up period was 2017-2021.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). However, the ground truth was "hospitalizations with HF as primary diagnosis" as recorded in the national health database, implying that these diagnoses were made by qualified healthcare professionals as part of routine clinical care documented within the SNDS.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1 for establishing the ground truth diagnoses. The study relies on “hospitalizations with HF as primary diagnosis” from the national health database, suggesting that these are established clinical diagnoses within the healthcare system.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The study focuses solely on the standalone performance of the SignalHF algorithm.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The FORESEE-HF study evaluated the SignalHF algorithm's performance in predicting heart failure hospitalizations based on CIED data and personal health records.

7. Type of Ground Truth Used

The ground truth used was outcomes data, specifically "hospitalizations with HF as primary diagnosis" recorded in the French national health database (SNDS).

8. Sample Size for the Training Set

• Training Cohort Sample Size: 7,556 patients

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

The document states that the algorithm computes the HF score using physiological measures from compatible CIEDs and available Personal Health Records (demographics). It also mentions that the "recovery threshold on the SignalHF score established during the learning phase of the algorithm and fixed for all patients". This implies that the ground truth for the training set, similar to the test set, was derived from the same data sources: "hospitalizations with HF as primary diagnosis" documented within the SNDS database. The training process would have used these documented HF hospitalizations as the target outcome for the algorithm to learn from.

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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 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.

The Global Hypoperfusion Index (GHI) parameter provides the clinician with physiological insight into a patient's likelihood of a global hypoperfusion event on average 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The GHI feature is intended for use in surgical or nonsurgical patients. The product predictions are adjunctive for reference only and no therapeutic decisions should be made based solely on the GHI parameter.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information. It primarily presents the FDA's 510(k) clearance letter and a summary of the device, its indications for use, and a comparison to predicate devices, stating that performance testing was executed and that no clinical trial was performed for the 510(k) submission.

However, based on the available information, here's what can be extracted and inferred:

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

The document mentions that 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 and alerts the clinician on average 10-15 minutes before SvO2 reaches 60%. It also states that the GHI algorithm provides an index from 0 to 100 where the higher the value, the increased likelihood that a global hypoperfusion event will occur.

While specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or AUC) and their corresponding achieved performance values are not explicitly stated in the provided text, the overall conclusion is that the algorithm "has successfully passed functional and performance testing" and "meets the predetermined design and performance specifications." This implies that internal acceptance criteria were met, even if they are not detailed here.

Example (Hypothetical, as not provided in text):

2. Sample size used for the test set and the data provenance:

• Sample Size: The text states, "Prospective analyses of retrospective clinical data from multiple independent datasets, comprised of data from a diverse set of patients over the age of 18 years undergoing surgical procedures with invasive monitoring, were analyzed to verify the safety and performance of the subject device." However, the exact sample size (number of patients or data points) for the test set is not specified.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: "Prospective analyses of retrospective clinical data" implies that existing (retrospective) data was collected and then analyzed in a forward-looking (prospective) manner for the purpose of the study.

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

The text does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.

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

The text does not provide any information regarding an adjudication method for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The text explicitly states: "No clinical trial was performed in support of the subject 510(k)." This indicates that an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted for this submission.

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

Yes, a standalone performance evaluation was conducted. The text states:

• "Algorithm performance was tested using clinical data."
• "The algorithm was tested at the algorithm level to ensure the safety of the device. All tests passed."
• "Prospective analyses of retrospective clinical data... were analyzed to verify the safety and performance of the subject device."

This confirms that the algorithm's performance was assessed independently.

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

The ground truth for a "global hypoperfusion event" is explicitly defined in the Indications for Use as: "SvO2 ≤ 60% for at least 1 minute." This is an objective physiological measurement (outcomes data) rather than expert consensus or pathology.

8. The sample size for the training set:

While the text mentions that "patient waveforms were collected in support of the development and validation of the GHI algorithm," the sample size for the training set is not specified.

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

Given that the ground truth for the device's output is based on SvO2 measurements, it is highly probable that the ground truth for the training set was established using the same objective physiological measurement: SvO2 ≤ 60% for at least 1 minute. The text implies that clinical data (patient waveforms) were used for both development and validation.

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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. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also 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. 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 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.
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 Pressure Cable:
The HemoSphere Advanced 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 hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor 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 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 Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.
HemoSphere Advanced Monitoring Platform, subject of this submission, consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on the monitor screen and its five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Technology Module (K213682 cleared, June 22, 2022), HemoSphere ForeSight Module (K213682, June 22, 2022), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). Additionally, the HemoSphere Advanced Monitoring Platform includes the Acumen Hypotension Prediction Index software feature (DEN160044 granted March 16, 2018) and the Acumen Assisted Fluid Management software feature (DEN190029 granted November 13, 2020). The HemoSphere Advanced Monitor also has wired and wireless capabilities, which was originally used only for connecting to a Hospital Information System (HIS) for data charting purposes. This capability is now used to allow it to stream continuously monitored data to the Viewfinder Remote, a mobile device-based application, for remote viewing the information (K211465, cleared July 8, 2021). The remotely transmitted data from the patient monitoring sessions include all hemodynamic parameter data and the associated physiological alarm notifications, historical trend data, and parameter waveform data.

HemoSphere Advanced Monitoring platform as cleared in K213682 cleared June 22, 2022, is being modified as follows:

1. Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
   The AFM software feature (AFM algorithm + AFM GUI), which informs clinicians of patient fluid responsiveness (K213682, cleared June 22, 2022), allows for manual fluid tracking, and resides on the HemoSphere Advanced Monitor.
   The AFM software feature is being modified to allow for an automated fluid tracking mode as the default mode. Users can switch to the optional manual fluid tracking mode through the advanced settings menu. This automated fluid tracking mode for the AFM software feature is achieved via two components namely, the Acumen AFM Cable and the Acumen IQ fluid meter (both devices subject of this 510(k)). No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automated fluid tracking mode via the Acumen AFM cable and Acumen IO fluid meter.
   The Acumen AFM Cable is a reusable cable that connects the Acumen IO fluid meter to the HemoSphere Advanced Monitoring Platform and converts the flow rate received from the Acumen IQ fluid meter to total volume for the HemoSphere monitor to be used by AFM software feature. No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automatic fluid tracking mode. The Acumen IQ fluid meter is a sterile, single use device that measures the flow of fluid delivered to a patient through the intravenous line to which it is connected.
   When used together, the Acumen IQ fluid meter with the Acumen AFM Cable connected to a HemoSphere monitor, the fluid volume can be automatically tracked and displayed on the monitor as part of the AFM software feature screens.

2. Automatic Zeroing of the Heart Reference Sensor (HRS)
   The ClearSight Module (CSM), initially cleared in K201446 on October 1, 2020, is a non-invasive monitoring platform that includes a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight/Acumen IQ Finger Cuffs.
   The Pressure Controller (also referred to as 'Wrist unit' or PC2) is connected to the patient via a wrist band. The Pressure Controller connects to the ClearSight Module (CSM) on one end and with the Heart Reference Sensor (HRS) and the finger cuff on the other. The connection to the CSM provides power and serial communication. The Pressure Controller is designed to control the blood pressure measurement process and send the finger arterial pressure waveform to the CSM. The CSM software transforms the finger level blood pressure measurements into the conventional radial blood pressure.
   In the predicate HemoSphere (K213682, cleared on June 22, 2022), as part of the ClearSight workflow, the user was required to zero the HRS prior to monitoring by aligning both ends of the HRS, the heart end and the finger end, and pressing the "0" button on the HemoSphere Graphical User Interface (GUI). After zeroing the HRS, the user is required to place both ends of the HRS in the appropriate location and then they can begin monitoring.
   For the subject device, the Pressure Controller (PC2) firmware has been updated to include a mathematical model that automatically calculates the zero offset of the HRS based on the age of the specific HRS at the time of use. With the addition of the mathematical model, the user is no longer required to zero the HRS prior to start of monitoring since the system now has the zero-offset calculated. As such, the HemoSphere Advanced Monitor graphical user interface (GUI) was updated to remove the Zero HRS step as part of the Zero & Waveform screen and ClearSight setup.
   The ClearSight Module firmware was also updated as part of support for the Automatic Zeroing of HRS feature. The firmware update included additional logging to support HRS calibration, bug fixes and updates to communication to the pressure controller to support display of proper HRS calibration information.

3. Patient Query
   As cleared in K213682, when the user queried for patient information, all patient records that match the search criteria were sent to the HemoSphere platform (from the Viewfinder Hub) for the user to review. With this update, only 30 records are shared at a time between the Viewfinder Hub and HemoSphere monitor.

4. Miscellaneous Updates
   Miscellaneous updates include:

• Bug fixes -
• Cybersecurity updates -
• Operator's manual updates -
• Heart Reference Sensor Instructions for Use update -

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Edwards Lifesciences, LLC, regarding the HemoSphere Advanced Monitor and related components. It does not contain the detailed acceptance criteria and study proving device performance in the way typically required for AI/ML-driven diagnostic devices. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new clinical claim with a standalone performance study.

Therefore, many of the requested details about acceptance criteria, human expert involvement, ground truth, and training set information are not available in this specific regulatory document, as they are not typically required for a 510(k) submission for device modifications like those described here. The "Acumen Assisted Fluid Management software feature" is mentioned, and an "AFM algorithm" is referenced, but detailed studies on its performance metrics are not included in this summary.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Device Performance Study (Partial Information)

This 510(k) notification describes modifications to an existing device (HemoSphere Advanced Monitoring Platform) and new components (Acumen AFM Cable, Acumen IQ fluid meter). The primary goal is to demonstrate substantial equivalence to a previously cleared predicate device (K213682). As such, the performance data presented is focused on verifying that the modifications do not adversely affect safety and effectiveness, rather than establishing new clinical performance metrics or comparing AI performance against human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria for AI performance in the way one would for a new AI diagnostic claim (e.g., sensitivity, specificity, AUC). Instead, it lists various verification and validation activities performed to ensure the modified device functions as intended and remains safe and effective.

Summary of Performance Data Presented:

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified for any quantitative testing that would typically involve a "test set" in the context of AI model validation (e.g., number of patient cases, number of images). The performance data cited are primarily bench simulations and system-level verification, not a clinical study with a patient test set.
• Data Provenance: Not specified, as no new clinical data or specific patient test sets are described. The reference to "bench simulation" suggests data generated in a lab environment.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable/Not Provided: Since "No new clinical testing was performed" for this 510(k), there is no mention of expert involvement for establishing ground truth on a clinical test set. The original AFM algorithm clearance (DEN190029) might contain this information, but it's not in this document.

4. Adjudication Method for Test Set

• Not Applicable/Not Provided: No clinical test set described.

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

• No: The document explicitly states, "No new clinical testing was performed." Therefore, no MRMC study was conducted or reported in this submission.

6. Standalone (Algorithm Only) Performance Study

• Partial/Limited: While the document mentions "AFM outputs when the fluid meter mode was unlocked... were tested using a bench simulation," it does not provide quantitative results (e.g., accuracy, precision) for the algorithm's performance in a standalone setting. The focus is on the functionality and safety of the hardware additions (cable, meter) and the automation of fluid tracking for an existing algorithm. The "core predictive algorithm for the Assisted Fluid Management software feature" is stated to be from the predicate device (K213682), which itself refers back to DEN190029.

7. Type of Ground Truth Used

• Not explicitly stated for AI performance: For the "bench simulation" of AFM outputs, the "ground truth" would likely be the known, controlled fluid flow rates programmed into the simulation. No external clinical ground truth (e.g., pathology, long-term outcomes) is described in relation to the AI/AFM performance in this document.

8. Sample Size for Training Set

• Not Provided: The document focuses on demonstrating substantial equivalence of modifications. Information about the training set size for the AI algorithm (Acumen Assisted Fluid Management software feature) would have been part of its original clearance (DEN190029), not this subsequent 510(k) for modifications and new hardware. It mentions: "No modifications have been made to the previously cleared AFM algorithm."

9. How Ground Truth for Training Set Was Established

• Not Provided: Similar to point 8, this information would pertain to the original clearance of the AFM algorithm (DEN190029) and is not detailed in this document.

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The Edwards 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 is intended for use in surgical or non-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 is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.

The Acumen Hypotension Prediction Index parameter (HPI) provides the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients. By default, the software defines a hypotensive event as mean arterial pressure (MAP)

The Edwards Acumen Hypotension Prediction Index (HPI) software feature was evaluated through algorithm verification and a usability study. The key aspects of the evaluation are as follows:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on verifying that the changes to the HPI algorithm (adjustable MAP targets) and the expansion to non-surgical patients did not negatively impact its safety and effectiveness. Specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated in the provided text. Instead, the document states:

• "The results establish that the usage of the HPI algorithm with the adjustable Mean Arterial Pressure (MAP) targets for hypotension (55, 60, 70, 75, 80, 85 mmHg) did not adversely affect the safety and effectiveness of the subject device."
• "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."

Without specific performance metrics and their corresponding acceptance thresholds, a table of acceptance criteria versus reported performance cannot be fully constructed from the provided text. The overall reported performance is that the device meets the implicit acceptance criterion of not adversely affecting safety and effectiveness with the modifications.

2. Sample Size and Data Provenance for Test Set:

• Algorithm Verification: The algorithm verification was performed using "clinical data." For the expanded non-surgical indication, "non-surgical clinical data collected retrospectively" was used.
• Sample Size: The document does not specify the sample size for the clinical data used in the algorithm verification test set.
• Data Provenance: The data used for the non-surgical indication was "retrospectively" collected. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size of human readers improving with AI vs. without AI assistance. The HPI is an "Adjunctive Predictive Cardiovascular Indicator" providing "additional quantitative information" and is "not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter," suggesting it is an aid rather than a replacement for human decision-making. However, the exact nature of human-in-the-loop studies, if any, is not detailed.

6. Standalone Performance:

Yes, a standalone (algorithm only) performance evaluation was done through the "Algorithm Verification" section. The verification confirmed that the modified algorithm, with adjustable MAP targets, did not adversely affect safety and effectiveness. This indicates an evaluation of the algorithm's performance independent of real-time human interaction.

7. Type of Ground Truth:

The ground truth used for algorithm verification appears to be based on observed "hypotensive events" defined by Mean Arterial Pressure (MAP) falling below user-defined thresholds (e.g.,

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