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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 in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

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

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone Performance Study

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

9. How Ground Truth for the Training Set Was Established

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

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