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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 pediativ critical care patients requiring of venous oxygen saturation (Sv02 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).
The HemoSphere Advanced Monitor with HemoSphere ClearSight module is a non-invasive monitoring platform intended to continuously and noninvasively measure blood pressure and associated hemodynamic parameters.
The HemoSphere Advanced Monitoring Platform when used with ClearSight Module uses the same technology as the predicate device. The volume clamp method of Peñáz is the measurement method, and the pressure waveform reconstruction is based on the generalized transfer function and level of correction of Gizdulich.
The platform also includes the Acumen Hypotension Prediction Index (HPI) feature for the ClearSight (non-invasive) technology. Currently, the HemoSphere Pressure Cable enables the HPI feature when connected to an Acumen IQ sensor. This feature has been updated to also enable the HPI feature when connected to the Acumen IQ finger cuff (ClearSight finger cuff).
The modified ClearSight System receives the pressure signal from the finger cuff and reconstructs it to a radial arterial pressure representation of the signal. This radial reconstructed signal is then used to calculate the previously available key hemodynamic parameters; PR, MAP, SYS, DIA, PPV and SVV. Additionally, the radial reconstructed signal is also used to calculate the parameters associated with the Hypotension Prediction Index feature (HPI, Eadyn, and dP/dt).
The cardiac output (CO) and other measurements derived from cardiac output, such as stroke volume (SV), cardiac output index (CI), stroke volume index (SVI) remain unchanged and will continue to use previously cleared ClearSight algorithm to reconstruct the finger pressure waveform into a brachial arterial pressure waveform.

The provided text describes the HemoSphere Advanced Monitoring Platform, which is a medical device. The submission focuses on modifications to the ClearSight algorithm and the addition of the Acumen Hypotension Prediction Index (HPI) feature for non-invasive technology.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." and "All tests passed." for various types of testing. The primary performance claim is related to the substantial equivalence to the predicate device, particularly regarding safety and effectiveness.

For the Acumen HPI feature, the indication states: "The Acumen HPI feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

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