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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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI 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 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:
The noninvasive 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 sensorsis 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 noninvasive 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.
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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI 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 Hypotension Prediction Index (HPI) parameter.
Refer to the ClearSight finger cuff and Acumen IO finger cuff indications 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.

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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics." The acceptance is implied by the successful clinical performance study demonstrating that the usage of the HPI algorithm with non-invasive technology did not adversely affect the safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions "multiple independent datasets" for the clinical performance study. It states these datasets were comprised of "patients over the age of 18 years undergoing surgical procedures with both minimally invasive and non-invasive monitoring." However, a specific numerical sample size for the test set is not provided.
• Data Provenance: The data was from "Prospective analyses of retrospective clinical data." The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document states that the HPI feature defines a hypotensive event as "mean arterial pressure < 65 mmHg for at least one minute in duration," which is an objective physiological measure, not one requiring expert interpretation for ground truth. For other parameters, substantial equivalence to the predicate device is claimed, implying the established methods for those measurements serve as ground truth or reference.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Given the nature of the device (physiological monitoring), traditional adjudication methods involving expert review of images or diagnoses are unlikely to be directly applicable in the same way as, for example, diagnostic imaging AI. The ground truth for hypotension is defined objectively by MAP thresholds.

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 MRMC comparative effectiveness study involving human readers and AI assistance is mentioned or implied. The HemoSphere Advanced Monitoring Platform and its HPI feature are presented as tools for clinicians to gain physiological insight, not as AI that directly 'assists' a human reader in interpreting complex visual data. The HPI feature is described as providing "additional quantitative information... for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." There is no discussion of human reader improvement or effect size.

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

Yes, a standalone performance of the algorithm was done as part of the "Algorithm Verification (Clinical Performance Data)" and "Clinical Performance" sections. The algorithms (ClearSight algorithm update and Acumen HPI feature) were tested using clinical data to establish that their usage did not adversely affect safety and effectiveness. This implies evaluation of the algorithm's output against clinical ground truth without direct human interpretation of the algorithm's internal workings or intermediate outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth for the Acumen HPI feature, as implied by its definition, is physiological outcomes data: "mean arterial pressure < 65 mmHg for at least one minute in duration." For other measured and derived hemodynamic parameters, the ground truth would typically be established by validated reference methods or the performance against the predicate device which itself has established accuracy.

8. The sample size for the training set

The sample size for the training set is not explicitly provided. The document states that "No modifications to the core predictive HPI algorithm have been made from the granted version in DEN160044 (granted March 16, 2018)." This suggests the original HPI algorithm was trained prior to this submission and its training data is not detailed here. The current submission focuses on verifying the algorithm's performance with non-invasive technology and changes to the ClearSight algorithm, not on re-training.

9. How the ground truth for the training set was established

This information is not provided in the document for the HPI algorithm specifically. Since the core HPI algorithm was not modified, its original training ground truth would have been established during its initial development and clearance (DEN160044). For physiological monitoring devices, training ground truth typically comes from simultaneously acquired data from a highly accurate, often invasive, reference standard.

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