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Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by 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 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 Autoregulation Index (CAI) Algorithm.

The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index is in effect an index of cerebral autoregulation, and the renaming results in a labeling change. The evidence to support the proposed labeling change for the Cerebral Autoregulation Index algorithm demonstrates the capability of CAI to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired, as expressed by the level of coherence or lack thereof between MAP (as a surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral blood flow) of the patient.

The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence between MAP and cerebral StO2. The output will be represented as an index value in a trend plot.

MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).

CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas a low CAI value (CAI

Here’s a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Cerebral Autoregulation Index (CAI) Algorithm

The document describes a 510(k) submission for a name change (and re-clarification of its meaning) of an existing device (Cerebral Adaptive Index (CAI) Algorithm) to Cerebral Autoregulation Index (CAI) Algorithm. The core algorithm and its function remain the same. The performance data presented appears to be the original validation data for the algorithm, supporting the claim that the renamed device retains its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 50 subjects.
   • Data Provenance: Retrospectively obtained from 3 clinical sites:
     • Northwestern University, Chicago, USA
     • UC Davis, Sacramento, USA
     • Amsterdam UMC, Amsterdam, The Netherlands
   • Patient Characteristics: Adult surgical patients (cardiac and general surgery) over 18 years of age.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

   • The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth was established algorithmically based on physiological measurements.

3. Adjudication Method:

   • Not applicable/Not mentioned. The ground truth was established via a polynomial fit of CBFV-MAP data to determine LLA and ULA, and then a rule-based classification (Intact or Impaired) was applied. There's no indication of human adjudication of this ground truth.

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

   • No MRMC study was done, as this algorithm is not intended for human interpretation or direct assistance in a diagnostic image reading scenario. Its output is an index value representing a physiological state.

5. Standalone Performance:

   • Yes, a standalone performance evaluation was conducted. The study assessed the algorithm's ability to discriminate between "Intact" and "Impaired" cerebral autoregulation conditions based on its calculated CAI value, against a ground truth derived from physiological measurements (CBFV-MAP).

6. Type of Ground Truth Used:

   • Physiological Ground Truth: The ground truth for cerebral autoregulation status (Intact vs. Impaired) was established using a polynomial fit of Cerebral Blood Flow Velocity (CBFV) and Mean Arterial Pressure (MAP) data. Specifically, LLA (Lower Limit of Autoregulation) and ULA (Upper Limit of Autoregulation) were determined from this data, and an autoregulation status was assigned based on MAP's relationship to these limits:
     • Impaired: MAP ≤ LLA or MAP ≥ ULA
     • Intact: LLA

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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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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 (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere 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.

Cerebral Adaptive Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to show the level of coherence between MAP and cerebral StO2. The output will be represented as an index value and a trended graph.

MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).

The CAI parameter can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events. It helps the clinician recognize/ identify possible causes of, for example, decrease in StO2 and clinical events related to StO2 decrease (e.g., hypotension as opposed to inadequate oxygen content).

CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will only be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation Whereas a low CAI value (CAI

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Cerebral Adaptive Index (CAI) Algorithm

The Cerebral Adaptive Index (CAI) Algorithm is an informational index designed to assess the coherence between Mean Arterial Pressure (MAP) and Absolute Levels of Blood Oxygenation (StO2) in cerebral tissue.

1. Acceptance Criteria and Reported Device Performance

The performance goals for the CAI algorithm were established using a CAI threshold of 45.

Conclusion: The device met all pre-defined acceptance criteria for sensitivity, specificity, and ROC AUC at the specified CAI threshold of 45.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 145 subjects aged 18 or older.
• Data Provenance: Retrospectively obtained from four different clinical sites within the US:
  • Northwestern University, Chicago
  • UC Davis, Sacramento
  • University of Minnesota, Minneapolis
  • Stanford University, Stanford
• Patient Characteristics: Adult surgical patients (cardiac surgery, general surgery, and surgical ICU) whose StO2 (via Foresight Sensors) and MAP (via Flotrac Sensors) were being monitored. Patients were randomly selected.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth.

4. Adjudication Method for Test Set

The document does not explicitly state an adjudication method. The ground truth was based on the Pearson's Correlation Coefficient (Corr) between MAP and StO2 from the clinical data.

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

An MRMC comparative effectiveness study was not mentioned in the provided text. The study focused on the standalone performance of the algorithm.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The reported sensitivity, specificity, and ROC AUC values are for the CAI Algorithm operating without human intervention, based on the retrospective clinical data.

7. Type of Ground Truth Used

The ground truth was established by classifying the relationship between MAP and StO2 using the Pearson's Correlation Coefficient (Corr) from the utilized time-series clinical data.

• Weak/Moderate MAP-StO2 association: 0

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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. 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 Intended Use statement below 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 crtical care patients requiring of venous oxygen saturation (SvO2 and Scv02) 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 Lifesciences 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 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 consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and 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 (K190205 August 29, 2019). HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).

The provided FDA 510(k) summary (K221704) for the HemoSphere Advanced Monitoring Platform does not contain a table of acceptance criteria and reported device performance for the modifications made (specifically the Right Ventricular Pressure (RVP) algorithm). While it states that "All tests passed" and "demonstrated that the subject devices meet their predetermined design and performance specifications," specific numerical performance metrics and their corresponding acceptance criteria are not detailed in this document.

However, based on the information provided, here's a breakdown of the other requested information regarding the study supporting the device:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications" and "All tests passed," but it does not specify the quantitative acceptance criteria or the numerical results achieved by the device against those criteria.

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

The document states: "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm."

• Sample Size for Test Set: Not specified. The document does not provide the number of patients or waveforms used for the clinical data collection for the RVP algorithm validation.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable/Not specified. The document mentions the collection of "clinical data (waveforms)" for the RVP algorithm validation, but it does not describe a process involving human experts to establish ground truth from this data. The RVP algorithm likely derives its parameters directly from physiological waveform data obtained from the Swan-Ganz Module and Pressure Cable, rather than relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As there is no mention of human expert-established ground truth, an adjudication method is not described.

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

No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in a comparative context. The device focuses on monitoring physiological parameters rather than image interpretation or diagnostic tasks involving human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The validation of the RVP algorithm described in the document is a standalone performance assessment. The statement "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm" implies that the algorithm's performance was evaluated based on this collected data. The conclusion that the device "has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies" further supports that the algorithm's performance was assessed. However, specific standalone performance metrics are not provided.

7. Type of Ground Truth Used for the Test Set

The ground truth for the RVP algorithm's validation would be the physiological waveform data itself, specifically from the Swan-Ganz Module and Pressure Cable. The algorithm processes this raw physiological data to derive parameters like SYSRVP, DIARVP, MRVP, PRRVP, RV dp/dt, and RVEDP. The validation would involve comparing the algorithm's derived parameters against established methods or calculations from the same direct physiological measurements (e.g., from the Swan-Ganz catheter and pressure sensors).

8. Sample Size for the Training Set

Not specified. The document mentions "clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm," but it does not differentiate between data used for design/training and data used specifically for validation (test set), nor does it specify the sample size for any such training.

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

Not specified/Not explicitly described. Given that the RVP algorithm processes physiological signals from existing, cleared hardware, the "ground truth" for any potential training would inherently be the raw physiological signals themselves, as measured by the Swan-Ganz Module and Pressure Cable. The algorithm's development would likely be based on established physiological principles and signal processing techniques to derive the mentioned RVP parameters. The document does not detail a specific "training set" or a separate process for establishing ground truth for training data beyond the intrinsic nature of the physiological measurements.

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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 of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. 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 Intended Use statement below for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:

The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and 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 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 Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and 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 Tissue Oximetry Module (K190205 August 29, 2019), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).

Acceptance Criteria and Device Performance for Edwards HemoSphere ClearSight Module

Based on the provided text, the Edwards HemoSphere ClearSight Module has undergone a modification to its existing APCO algorithm. The acceptance criteria and performance evaluation are related to ensuring this modification did not adversely affect the safety and effectiveness of the device, particularly concerning Cardiac Output accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states that "retrospective analysis of clinical data from multiple independent datasets, comprised of data from patients over the age of 18 years" was used. However, a specific numerical sample size (e.g., number of patients or data points) is not provided in the document.
• Data Provenance: The data was "retrospective analysis of clinical data from multiple independent datasets." The country of origin of the data is not specified.

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

This information is not provided in the document. The text does not describe how the "ground truth" for the clinical data used in the retrospective analysis was established, nor does it mention the use of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described in the document. This study focuses on an algorithm modification for a medical device (HemoSphere ClearSight Module) measuring physiological parameters, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance evaluation of the algorithm was done. The "Algorithm Verification (Clinical Performance Data)" section specifically states: "Algorithm performance was tested using clinical data." This indicates an evaluation of the algorithm's performance independent of real-time human interaction.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document refers to the evaluation of "Cardiac Output accuracy." For a device that measures physiological parameters like Cardiac Output, the "ground truth" would typically refer to a gold standard measurement technique for that parameter. However, the exact gold standard method used to establish the ground truth for Cardiac Output in the clinical data is not explicitly stated in the provided text. It implies the use of "clinical data" which would have reference measurements for comparison but does not detail the nature of these reference measurements.

8. The Sample Size for the Training Set

The document only mentions "retrospective analysis of clinical data" for testing the algorithm modification. It does not provide any information regarding a "training set" or its sample size. This suggests that the modification might have been made to an existing algorithm, and the focus of this submission is on verifying the impact of that modification using a test set, rather than developing a new algorithm from scratch requiring a separate training set.

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

Since no training set is mentioned, this information is not provided in the document.

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Indications for Use: 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-Gatheter indications for use statement for information on target patient population specific to the catheter being used.

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

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable

The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and Scv02) 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 Lifesciences Acumen Hypotension Prediction 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 consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and 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 Tissue Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).

The regulatory submission K223127 for the HemoSphere Advanced Monitoring Platform indicates a modification to the existing StO2 algorithm of the HemoSphere ForeSight Oximeter Cable. The submission claims substantial equivalence to a predicate device (K213682 cleared June 22, 2022) and an additional predicate (Fore-Sight Elite Module Tissue Oximeter, K143675 cleared April 10, 2015) for the StO2 algorithm.

Here's an analysis based on the provided text, fulfilling the requested information points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All testing passed without exception" and the "modification did not adversely affect the safety and effectiveness of the subject device." However, specific numerical acceptance criteria (e.g., accuracy +/- X%, bias Y, precision Z) and the corresponding reported performance values for the StO2 algorithm are not explicitly provided in the given text.

The text vaguely indicates that:

• "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
• "The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification."
• "Design, materials, energy source, user interface, measurement principle and all performance specifications of the modified HemoSphere ForeSight Oximeter cable remain unchanged."

Without the actual specific criteria and reported values from the predicate device's clearance, a detailed table with numerical data cannot be generated from this document.

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

The document does not specify the sample size used for the test set. It mentions "Algorithm Verification" and "System Verification" without detailing the number of cases or patients included in these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Given that the modified device measures "absolute regional hemoglobin oxygen saturation (StO2)," the ground truth would typically be established through a reference method (e.g., co-oximetry of arterial and venous blood samples, or another validated oximetry technique) rather than expert consensus on images.

4. Adjudication Method for the Test Set

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

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

The document does not indicate that an MRMC comparative effectiveness study was performed. The device is a monitoring platform providing quantitative physiological parameters, not an imaging device requiring human reader interpretation in the same way.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was done. The submission explicitly states:

• "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
• "The results establish that the modification did not adversely affect the safety and effectiveness of the subject device."

This "Algorithm Verification" section refers to directly testing the algorithm's performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used but implies it would be a comparison to existing specifications from the predicate devices. For a tissue oximeter measuring StO2, the ground truth would typically involve comparison to a validated reference method for oxygen saturation, possibly through in-vivo or in-vitro testing. It is not expert consensus on images or pathology in this context.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. This is a modification to an existing algorithm, so the original algorithm would have been developed and trained, but details about that original training are not in this submission.

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

The document does not provide details on how the ground truth for the training set (of the original algorithm) was established. It only refers to the modification of an "existing StO2 algorithm."

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The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• · BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only;
• · C.O. monitoring and A-Fib are intended for adult patients only;
• · ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• · rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO₂), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment, whereas N1 configured with WMTS technology can be used inside the hospital only. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• . BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• BeneVision N19 Patient Monitor ●
• BeneVision N22 Patient Monitor ●
• BeneVision N1 Patient Monitor

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

This document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K202405).

The information provided primarily details the device's technical specifications and comparisons to a predicate device, rather than a full study proving the device meets acceptance criteria for a specific medical condition or AI diagnostic output.

Therefore, I cannot fully answer all parts of your request as the document does not contain the detailed clinical study results (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or specific AI performance metrics) that would typically be found for a device requiring those types of studies (e.g., an AI-powered diagnostic tool).

However, I can extract the relevant information regarding the device's functional and technical performance as demonstrated in this 510(k) submission.

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

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are related to meeting the performance specifications of the predicate device and relevant consensus standards. The "reported device performance" is demonstrated through functional and system-level testing, ensuring the device meets its accuracy specifications for the various physiological parameters it monitors.

Table of "Acceptance Criteria" (Implied Specifications) and "Reported Device Performance" (Conformance):

Detailed Study Information (Based on Document Content):

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

   • The document states that "functional and system level testing" and "bench testing" were conducted.
   • However, no specific sample sizes for test sets (e.g., number of patients, number of data recordings) are provided for any of the performance evaluations.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are generic "bench testing" to ensure compliance with technical specifications and standards, not clinical studies.

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

   • Not applicable / Not provided. This document describes engineering and bench testing against pre-defined technical specifications and industry standards for physiological measurement accuracy. It does not describe a clinical study involving human experts establishing ground truth for diagnostic interpretation (e.g., for an AI algorithm interpreting medical images).

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

   • Not applicable / Not provided. Same reason as above.

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

   • No. This device is a patient monitor. It detects physiological parameters and provides alarms, and some interpretations of ECG (e.g., 12-lead ECG interpretation, arrhythmia detection). It is not an AI-assisted diagnostic device in the sense of image interpretation for which MRMC studies are typically performed. The document details that "optimized auditory ALARM SIGNALS" and "alarm highlight" were added, suggesting improvements to the human-device interface, but not a formal MRMC study on diagnostic improvement.

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

   • The document implies that algorithms for ECG (Mindray or Mortara algorithm for arrhythmia and ST-segment analysis) are embedded in the device. The listed accuracy specifications for these measurements (e.g., HR, ST, QT) reflect the standalone performance of these measurement algorithms and sensors against established benchmarks. However, a formal "standalone study" with detailed methodology, distinct from the general bench testing, is not specifically described or provided with separate results. The performance data listed (e.g., accuracy for HR, ST, QT) serves as the "standalone" performance verification for these integrated functionalities.

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

   • For physiological measurements (ECG, SpO2, NIBP, etc.), the "ground truth" would typically refer to reference measurement devices or calibrated simulators used during bench testing to verify the accuracy of the monitor's readings against a known, accurate value.
   • For the ECG interpretation (e.g., 12-lead ECG interpretation, arrhythmia detection), the ground truth for the algorithms would have been established during their development and previous clearance processes (Mindray or Mortara algorithms). This document focuses on demonstrating that the integration and revised features maintain that established accuracy rather than re-proving the core algorithms.

7. The sample size for the training set:

   • Not provided. This document pertains to the 510(k) clearance of updates to an existing patient monitor series. It does not detail the development or training of new AI/ML algorithms, which would typically involve substantial training datasets. The ECG algorithms (Mindray or Mortara) were presumably "trained" (or developed and validated) previously as part of their initial predicate clearances.

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

   • Not provided. (See point 7). For existing algorithms like Mortara or Mindray ECG algorithms, ground truth for their original development would likely have been established using large, diverse ECG databases with expert cardiologist interpretations and/or correlation with clinical outcomes where relevant. This particular 510(k) document is concerned with demonstrating equivalence and continued performance with minor changes, not the original algorithm development.

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The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The Viewfinder Remote mobile application can be used for supplemental near real-time remote display of monitored hemodynamic parameter data as well as Faults, Alerts and Notifications generated by the HemoSphere Advanced Monitoring Platform.

The HemoSphere Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.

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 (previously referred to as "Tissue Oximetry Module"; K190305 cleared, August 29, 2019), HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). 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.

The provided text describes several features and modifications to the HemoSphere Advanced Monitoring Platform, but it does not contain a specific table of acceptance criteria and reported device performance, nor does it detail a standalone AI algorithm study or an MRMC comparative effectiveness study for the machine learning features (like HPI or AFM).

The document primarily focuses on demonstrating substantial equivalence to predicate devices, and the performance data mentioned is generally high-level "All tests passed" rather than specific quantitative results against defined acceptance criteria for AI model performance.

Therefore, many of the requested details about the study that proves the device meets the acceptance criteria (especially for the AI/ML features) are not available in this document. The information that can be extracted relates more to the overall device functionality and compliance than to a detailed AI performance validation.

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

Information NOT available in the document regarding acceptance criteria and AI study specifics:

• 1. A table of acceptance criteria and the reported device performance for AI features: This level of detail is not provided. The document states that "Completion of all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications," and "Measured and derived parameters were tested using a bench simulation. Additionally, individual modules were tested at a system level to verify the safety of these modules." However, it does not enumerate specific acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) or quantitative performance results for the AI algorithms (HPI, AFM).
• 2. Sample size used for the test set and the data provenance, whether retrospective or prospective: This information is not provided. The document mentions "bench simulation" and "system level" testing but does not quantify the dataset size or its nature.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The document states, "No new clinical testing was performed in support of the subject 510(k)," indicating that specific MRMC studies for this submission were not conducted.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document states that the "Acumen Hypotension Prediction Index 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," and similarly for AFM, "No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions." This implies the AI features are intended for human-in-the-loop use, but it doesn't explicitly refer to a "standalone" performance study in the context of a typical AI performance evaluation. It does mention "Measured and derived parameters were tested using a bench simulation," which could include algorithm-only testing, but specific metrics are absent.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
• 8. The sample size for the training set: Not specified.
• 9. How the ground truth for the training set was established: Not specified.

Information that CAN be inferred or extracted (though limited for AI-specific performance):

• Regarding "Acumen Hypotension Prediction Index Feature" and "Acumen Assisted Fluid Management Feature":
  • The document explicitly states that for the Acumen HPI feature, "No modifications have been made to the previously granted AFM algorithm" (referring to the core algorithm, K203687), and for HPI Smart Alerts/Trends modifications, "There are no changes to the core HPI algorithm, the behavior of the HPI parameter display, nor the indications for use and intended use of the HPI parameter due to this Smart Trends/ Smart Alerts modification." This suggests that the core algorithms for HPI and AFM were previously cleared (DEN190029 for AFM and K203687 for HPI), and this submission focuses on incorporating and updating the display and connectivity of these features rather than re-validating the core algorithms themselves. This means the detailed AI performance validation, if done, would have been part of the previous submissions (DEN190029 and K203687).
  • The HPI feature defines hypotensive events as "mean arterial pressure

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

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and SevO2) 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 Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 3 kg.
· When used with small sensors, the Fore-Sight Elite tissue oximeter module 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 consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and 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 Tissue Oximetry Module (K190205 August 29, 2019), HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 cleared October 1, 2020).
The HemoSphere Advanced Monitor (K201446 most recently cleared October 1, 2020), subject of this submission, is being modified to enable connectivity to a Viewfinder Remote mobile application via a software-based Viewfinder Hub and Viewfinder Cloud.
The Viewfinder Remote mobile application provides clinicians with a supplemental near-real time display of the patient hemodynamic data from the connected HemoSphere Advanced Monitoring Platform. The Viewfinder Remote application is part of the Edwards Viewfinder network, which includes Viewfinder Hub and Viewfinder Cloud. The Viewfinder Remote mobile application functions as a supportive visual aid for patient status communication between clinicians and allows them to view multiple patient monitoring sessions at once from their mobile device. The near-real time updates to patient monitoring sessions includes non-invasive hemodynamic parameter data and the associated physiological alarm notifications, historical trend data and parameter waveform data.

The provided text describes modifications to an existing device, the HemoSphere Advanced Monitoring Platform, to include a new feature: the Viewfinder Remote mobile application. The primary predicate device is the HemoSphere Advanced Monitoring Platform itself (K201446). The submission focuses on the addition of the Viewfinder Remote and changes to the HemoSphere Advanced Monitor to support this remote viewing functionality.

The acceptance criteria and study information provided are primarily related to the safety and functionality of the new remote viewing feature and the integrated system, rather than the clinical performance of the underlying hemodynamic monitoring parameters. No clinical performance data is deemed necessary for the modifications.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for parameters like accuracy, sensitivity, or specificity for the Viewfinder Remote mobile application. Instead, it states that "All tests passed" for various verification activities, implying that the device met internal performance specifications for these tests. The focus is on ensuring data integrity, safety, and usability of the remote viewing function.

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

The document does not specify sample sizes for any of the verification tests (system, wireless, software, usability). It does not mention clinical data proving the device meets the acceptance criteria, as clinical data was not required for the modifications. The tests appear to be non-clinical (bench and simulated environment).

• Test Set Sample Size: Not specified.
• Data Provenance: Non-clinical (bench and simulated environment testing).

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

This information is not provided. The verification activities mentioned are technical and regulatory compliance tests, not typically requiring expert ground truth in the way a diagnostic algorithm's performance would. For the usability study, "clinicians" are mentioned as users, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was mentioned. The device (Viewfinder Remote) is a "supportive visual aid" for remote display of parameters, not an AI-assisted diagnostic tool that would improve human reader performance in interpreting complex medical images or data.

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

The Viewfinder Remote itself is a standalone application in the sense that it displays data from the HemoSphere monitor, but its "performance" is based on accurately reflecting the data generated by the primary monitoring platform. The verification activities focus on the integrity and accuracy of this data transfer and display, not on the Viewfinder Remote generating independent algorithmic outputs. The "Acumen Hypotension Prediction Index Feature" is mentioned as a component of the HemoSphere system, providing "additional quantitative information," but the document doesn't detail standalone performance studies for this specific AI feature outside of its integration with the HemoSphere platform and the context of the Viewfinder Remote submission.

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

For the HemoSphere Advanced Monitoring Platform itself, the ground truth for its core hemodynamic parameters would typically be established through validation against gold-standard invasive measurements or other well-established methods. However, for the modifications related to the Viewfinder Remote, the "ground truth" for the verification tests involved comparing the displayed data on the remote application against the data displayed on the primary HemoSphere monitor, and ensuring it passed technical and regulatory standards.

• For the Viewfinder Remote modifications: The ground truth for data integrity and accuracy would be the parameters and alarms generated and displayed on the HemoSphere Advanced Monitor itself.
• For the overall HemoSphere Advanced Monitor (implied from its existing clearance K201446 and general device type): Ground truth for hemodynamic parameters like cardiac output, pressure, and oxygen saturation would typically rely on established clinical measurement techniques (e.g., thermodilution for CO, direct arterial line measurement for BP, co-oximetry for SvO2).

8. The Sample Size for the Training Set

This information is not provided. Given that clinical data was not required for these specific modifications, and the focus is on a remote display application rather than a new diagnostic algorithm requiring extensive training data, a training set as typically understood for AI models is not explicitly mentioned. If the Acumen HPI feature involves AI, its training data details are not provided in this document.

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

This information is not provided. (See point 8).

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

The Acumen Hypotension Prediction Index Feature (DEN160044) consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (DEN160044) and HemoSphere Advanced Monitoring Platform (K180881) paired with the FloTrac IQ or Acumen IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The software includes the Acumen Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), and additional graphical user interface features. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure

Here's a breakdown of the acceptance criteria and study information for the Acumen Hypotension Prediction Index based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the overall goal of the device, as described in the Indications for Use and Device Description, is to predict hypotensive events (MAP

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