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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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module
The non-invasive Fore-Sight Elite tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The Fore-Sight Elite tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
· When used with large sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on adults and transitional adolescents ≥40 kg.
· When used with medium sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on pediatric subjects >3 kg.
· When used with small sensors, the Fore-Sight Elite tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.
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 ClearSight Module
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

Intended use - Viewfinder Remote:
Viewfinder Remote is a mobile application which provides supplemental remote near real-time display of non-invasive hemodynamic parameters measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.

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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