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Indications for Use: 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. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. 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-Gatheter 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 Scv02) 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 40 kg.

· When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >3 kg.

· When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects

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 Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).

The regulatory submission K223127 for the HemoSphere Advanced Monitoring Platform indicates a modification to the existing StO2 algorithm of the HemoSphere ForeSight Oximeter Cable. The submission claims substantial equivalence to a predicate device (K213682 cleared June 22, 2022) and an additional predicate (Fore-Sight Elite Module Tissue Oximeter, K143675 cleared April 10, 2015) for the StO2 algorithm.

Here's an analysis based on the provided text, fulfilling the requested information points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All testing passed without exception" and the "modification did not adversely affect the safety and effectiveness of the subject device." However, specific numerical acceptance criteria (e.g., accuracy +/- X%, bias Y, precision Z) and the corresponding reported performance values for the StO2 algorithm are not explicitly provided in the given text.

The text vaguely indicates that:

• "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
• "The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification."
• "Design, materials, energy source, user interface, measurement principle and all performance specifications of the modified HemoSphere ForeSight Oximeter cable remain unchanged."

Without the actual specific criteria and reported values from the predicate device's clearance, a detailed table with numerical data cannot be generated from this document.

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

The document does not specify the sample size used for the test set. It mentions "Algorithm Verification" and "System Verification" without detailing the number of cases or patients included in these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Given that the modified device measures "absolute regional hemoglobin oxygen saturation (StO2)," the ground truth would typically be established through a reference method (e.g., co-oximetry of arterial and venous blood samples, or another validated oximetry technique) rather than expert consensus on images.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set.

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

The document does not indicate that an MRMC comparative effectiveness study was performed. The device is a monitoring platform providing quantitative physiological parameters, not an imaging device requiring human reader interpretation in the same way.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was done. The submission explicitly states:

• "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
• "The results establish that the modification did not adversely affect the safety and effectiveness of the subject device."

This "Algorithm Verification" section refers to directly testing the algorithm's performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used but implies it would be a comparison to existing specifications from the predicate devices. For a tissue oximeter measuring StO2, the ground truth would typically involve comparison to a validated reference method for oxygen saturation, possibly through in-vivo or in-vitro testing. It is not expert consensus on images or pathology in this context.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. This is a modification to an existing algorithm, so the original algorithm would have been developed and trained, but details about that original training are not in this submission.

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

The document does not provide details on how the ground truth for the training set (of the original algorithm) was established. It only refers to the modification of an "existing StO2 algorithm."

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