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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 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 pediative 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 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

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.
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 three optional external modules: the HemoSphere Swan-Ganz Module (existing), the HemoSphere Oximetry Cable (existing) and the HemoSphere Pressure Cable (new to the platform). This version of the platform also includes the Acumen Hypotension Prediction Index feature.
The existing optional modules provide an interface to connect with currently cleared and commercially available Edwards Lifesciences Swan-Ganz catheters and Oximetry catheters (K803058, K822350, K905458, K924650, K934742, K940795, K053609 and K110167 and K160884).
The new HemoSphere Pressure Cable provides an interface to connect with currently cleared and commercially available Edwards Lifesciences FloTrac (K152980), FloTrac IQ (K152980) and TruWave DPT sensors (K142749).
All the sub-system modules provide the hardware and software technology to compute hemodynamic monitoring data that is then sent to the HemoSphere Advanced Monitor for visualization and storage.
As cleared under K163381 on April 14, 2017, 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 and pressure signals. 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 HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable (new to the HemoSphere platform) uses the same monitoring technology (pressure and pressure based Cardiac Output), the same computational algorithms and the same default alarm limits as the EV1000A Clinical Platform (K160552, cleared June 1, 2016).
The HemoSphere Pressure Cable also enables the Acumen Hypotension Prediction Index (HPI) feature when connected to a FloTrac IQ sensor similar to the EV1000A Clinical Platform (DEN160044, granted March 16, 2018).
The HemoSphere Pressure Cable when connected to a TruWave DPT sensor and a compatible Edwards Advanced Swan-Ganz catheter allows monitoring of a new parameter; Mean Pulmonary Arterial Pressure (MPAP).
Additionally, a HemoSphere Pressure-Out cable has been developed for the HemoSphere Advanced Monitor. This cable enables output of analog pressure signals (MAP, CVP or PAP) for display on an external patient monitor.

The provided text is a 510(k) summary for the Edwards Lifesciences HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, and Acumen Hypotension Prediction Index feature.

Based on the provided document, here's a breakdown of the acceptance criteria and the study proving the device meets them:

No clinical performance data (multi-reader multi-case study, standalone performance) for the Acumen Hypotension Prediction Index (HPI) feature is provided in this 510(k) summary. The document explicitly states: "Clinical data was not required for this device." The review of the Acumen HPI feature is described as "similar to that granted in DEN160044 on March 2018." Therefore, information regarding acceptance criteria and performance studies for the Acumen HPI feature would likely be found in the DEN160044 submission, not in this document.

The provided document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing (bench and simulated environment testing) for the new or modified components of the HemoSphere Advanced Monitoring Platform, particularly the HemoSphere Pressure Cable and the integration of the Acumen HPI feature (which itself was previously cleared).

Therefore, the following answers are based on the information provided for the HemoSphere system components and the integration of the HPI feature, not the HPI algorithm's performance itself.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission focuses on non-clinical testing for substantial equivalence, the "acceptance criteria" are not detailed as specific performance metrics with target values for accuracy, sensitivity, or specificity in a clinical context. Instead, the acceptance criteria are implicitly that the device performs functionally as intended and meets relevant safety and electromagnetic compatibility (EMC) standards. The "reported device performance" is that all tests passed, demonstrating functional equivalence to predicate devices and adherence to safety standards.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set for AI performance. The testing described is non-clinical (bench and simulated environment).
• Data Provenance: Not applicable for a clinical test set. The data originates from bench testing, simulated environments, and usability studies. No specific country of origin for clinical data is mentioned as none was gathered. The provenance is internal company testing. The studies were non-clinical.

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

• Not applicable for the type of testing described. Ground truth for the non-clinical tests (e.g., pressure measurements, electrical safety) would be established by reference standards, calibrated equipment, or engineering specifications, not by human experts interpreting data.
• For the usability study, "32 users with a mix of clinicians and nurses" were involved. Their qualifications are listed as "clinicians and nurses" but no further detail on their experience level is provided for establishing "ground truth" (as their role was to evaluate usability, not establish a clinical gold standard).

4. Adjudication Method for the Test Set

• Not applicable for the type of testing described (non-clinical verification). Adjudication is typically used in clinical studies where multiple human readers interpret data that may have ambiguity, which is not the case for electrical safety or bench performance verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical data was not required for this device."

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

• No, a standalone clinical performance study of the Acumen HPI algorithm was not presented in this submission. The submission states that the HPI feature is "similar to that granted in DEN160044 on March 2018." This implies that the standalone performance of the HPI algorithm was evaluated as part of the DEN160044 submission, not this K180881 submission.
• The tests performed were non-clinical, verifying the integration and function of the HPI feature within the new HemoSphere platform, rather than re-evaluating the core HPI algorithm's performance.

7. The Type of Ground Truth Used

• For the non-clinical performance and verification testing:
  • Bench Testing: Ground truth established through calibrated measurement devices, comparison to reference standards, and predetermined design specifications.
  • Electrical Safety/EMC: Defined by international standards (e.g., IEC 60601 series).
  • Software Verification: Defined by software requirements specifications and testing protocols.
  • Usability Study: User feedback against usability goals and metrics.
• For the Acumen HPI feature itself, the previous submission (DEN160044) would have defined its ground truth (e.g., actual hypotensive events observed in clinical data), but this information is not in this document. The current submission relies on the prior clearance.

8. The Sample Size for the Training Set

• Not applicable for this submission. This document describes the 510(k) clearance for a device (HemoSphere monitor and cables) and the integration of a previously cleared feature (Acumen HPI). It does not describe the training or development of the Acumen HPI algorithm itself. Training set information would reside with the data used to develop the Acumen HPI algorithm, likely part of the DEN160044 submission.

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

• Not applicable for this submission, as it does not detail the training set for the Acumen HPI algorithm. This information would be found in the documentation for the original DEN160044 submission for the Acumen HPI feature.

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