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Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

Swan-Ganz thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

ControlCath thermodilution catheters and Torque Support Thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

Swan-Ganz oximetry TD catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions. For 631NX55, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The Swan-Ganz catheters are cardiovascular diagnostic catheters intended for use on critical care patients. Swan-Ganz catheters are used to monitor the hemodynamic status of critically ill and injured patients. The catheters give clinicians the ability to measure right heart pressures, pulmonary artery occlusion pressure ("wedge"), sample mixed venous blood from the pulmonary artery, as well as measure cardiac output through thermodilution when used with a bedside physiologic monitor.

The subject Edwards Swan-Ganz product line is comprised of Base and Advanced Technology monitoring catheters. The Base Swan-Ganz catheter measures: right heart pressures, thermodilution cardiac output (room temperature and chilled) and provides a mechanism for pulmonary artery blood sampling for laboratory analysis. In addition to providing most of the same functionality as the Base models, the Advanced Swan-Ganz catheters provide the ability to continuously monitor the patient's mixed venous oxygen saturation, the balance between oxygen delivery and consumption, when used with an Edwards Lifesciences oximetry monitor or compatible bedside module system. It also monitors cardiac output with a compatible cardiac output computer.

This is a 510(k) premarket notification for a Class II medical device, specifically Swan-Ganz Flow-Directed Monitoring Catheters. The document is about demonstrating substantial equivalence to a legally marketed predicate device, not about proving the performance of a novel AI/ML device against specific acceptance criteria in a clinical study. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this document.

The "acceptance criteria" discussed here are related to demonstrating that the modified device (with SEBS balloons) performs equivalently to the predicate device (with latex balloons) in terms of its functional and safety aspects.

Here's the information that can be extracted or deduced from the provided text:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the tests. The document refers to "functional testing of the catheter balloon," "biocompatibility testing," "sterilization testing," and "usability and human factors testing" but does not provide quantities for the test articles or subjects involved in these tests.
• Data Provenance: Not explicitly stated. The tests are bench studies and laboratory tests related to device manufacturing and biological effects, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This information is typically relevant for studies involving human interpretation or subjective assessment of medical images or conditions where expert consensus is needed to establish ground truth. The tests described (functional, biocompatibility, sterilization, usability) are objective engineering and biological assessments.

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

• Not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among expert readers when establishing ground truth. The tests mentioned are objective evaluations and do not involve human adjudication in this context.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices. The device described is a medical catheter and the submission focuses on demonstrating substantial equivalence of a modified material.

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

• Not applicable. This submission is not for an AI/ML algorithm.

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

• Objective Test Standards and Regulations: The "ground truth" for the performance claims comes from objective engineering and biological standards and regulations.
  • Functional testing: Likely based on pre-defined engineering specifications for balloon performance.
  • Biocompatibility: ISO 10993-1:2018 and FDA guidance.
  • Sterilization: ISO 11135:2014 and FDA Quality System Regulation (21 CFR 820.30).
  • Usability and Human Factors: IEC 62366:2015 and FDA guidance.

8. The sample size for the training set:

• Not applicable. This submission is not for an AI/ML device that requires a training set.

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

• Not applicable. As above, no training set is relevant for this device type.

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