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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 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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