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The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

The provided text is an FDA 510(k) clearance letter and summary for the Swan-Ganz catheter. It primarily details the regulatory process, device description, and indications for use.

Crucially, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of proving device performance against specific metrics. The document explicitly states:

"The subject Swan-Ganz Base and Advanced catheters are identical to the predicate devices cleared in K160084 and K222117 in terms of design, performance specifications, and technological characteristics with the exception of the indications for use statement and other portions of the labeling. The are no changes to the design, technology, performance, materials, or specifications of the devices in this 510(k). The modifications to the subject devices are limited to labeling changes."

This indicates that the current submission (K233824) is for a labeling change only, and therefore, the performance of the device itself (its ability to accurately monitor hemodynamic pressures) would have been established during the clearance of the predicate devices (K160084 and K222117), not in this particular submission.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study proving the device meets acceptance criteria related to its performance.

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Swan-Ganz catheters:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and 834F75P are intended for adult and pediatric patients:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥ 12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

FloTrac sensors:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥ 12 years of age.

ClearSight finger cuffs:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients ≥ 12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.

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 in a hospital environment. 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 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 for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Pressure Cable (compatible with FloTrac sensors):
The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric 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 of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer 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

Swan-Ganz Catheters:
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

FloTrac Sensors:
The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensor minimally-invasively measures cardiac output and key hemodynamic parameters, which assist the clinician in assessing the patient's physiologic status and support clinical decisions related to hemodynamic optimization. The disposable sterile cable, with a red-connector interfaces, exclusively with an Edwards cable that is specifically wired for the pressure monitor being used. The disposable sterile cable, with a green-connector interfaces, exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware.
The FloTrac sensor has a straight, flow-through design across the pressure sensors with an integral flush device.

ClearSight finger cuffs:
The ClearSight finger cuffs, when used with an appropriate Edwards monitoring system, provide continuous, noninvasive hemodynamic monitoring. The ClearSight finger cuffs utilize the volume-clamp method to measure blood pressure with an inflatable bladder wrapped around the middle phalanx of the finger.

HemoSphere Advanced Monitor Platform:
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.

This document is a 510(k) summary for Edwards Lifesciences' Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and HemoSphere Advanced Monitoring Platform. The core of this submission is to expand the indications for use of these devices to include pediatric patients (≥12 years of age), in addition to their existing adult indications.

The information regarding acceptance criteria and the study that proves the device meets those criteria, as detailed in your request, is primarily found in the "Device Verification and Validation" and "Conclusion" sections. However, the FDA summary document only provides a high-level overview. It does not contain the detailed acceptance criteria table, precise performance metrics, sample sizes, ground truth establishment methods, or specific details about expert adjudication or MRMC studies, which are typically found in the full 510(k) submission or supporting clinical trial reports.

Based on the provided text, here's what can be extracted and what information is not present:

Key Takeaway from the FDA 510(k) Summary:

The primary purpose of this 510(k) submission is to expand the indicated patient population for the listed devices from adult-only to include pediatric patients aged 12 years and older. The submission claims that the devices perform similarly in this expanded pediatric population compared to adults, meeting predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Not Provided in this Document. The document states "within predefined acceptance criteria" but does not list these criteria or the specific reported device performance metrics against them.

Study Details (Based on available information):

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "the target pediatric population in a clinical study" but does not provide the number of patients.
   • Data Provenance:
     • Country of Origin: Not specified in this summary. Clinical studies are often multi-center, but no specific locations are mentioned.
     • Retrospective or Prospective: Not explicitly stated, but the phrase "clinical study" typically implies prospective data collection for regulatory submissions, especially for expanding indications to a new population.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of these hemodynamic devices, ground truth would likely be established by clinical measurements and potentially other validated reference methods, rather than expert interpretation of images or signals in the same way a radiologist might interpret an X-ray. Clinical experts (e.g., intensivists, anesthesiologists, cardiologists) would be involved in patient selection, data collection, and overseeing the study.

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

   • Adjudication Method: Not specified. This type of adjudication (e.g., multi-reader consensus) is more common in image-based diagnostic AI studies. For device performance measurement, agreement with a reference standard is the typical method.

4. 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:

   • MRMC Study: Not applicable/not performed for this type of device and study. MRMC studies are primarily for evaluating AI's impact on human interpretation tasks (e.g., radiologists reading images). This submission is for devices that directly measure physiological parameters and provide data, with one feature (Acumen HPI) providing "physiological insight" for reference. The study focuses on the device's performance in a new patient population, not on how it assists human readers in interpreting complex cases, except perhaps by providing accessible data. The Acumen HPI feature specifically states "no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter," indicating it's an informational tool rather than a definitive diagnostic AI assist requiring a MRMC study.

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

   • Standalone Performance: The study evaluated the devices' performance in the pediatric population. The devices themselves are "standalone" in that they acquire and process physiological signals to output parameters. The statement "The data demonstrate the performance in the expanded pediatric population ≥ 12 years of age and is substantially equivalent to their respective predicate devices for adult patient population ≥ 18 years of age" suggests an evaluation of the device's measurement accuracy and consistency.

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

   • Type of Ground Truth: Not explicitly stated, but for hemodynamic monitoring devices, ground truth is typically established by:
     • Reference Standards/Comparative Measurements: Comparing the device's measurements (e.g., cardiac output, blood pressure) against established, precise, and often more invasive or gold-standard methods (e.g., thermodilution, invasive arterial line measurements from validated transducers).
     • Clinical Outcomes/Safety Data: Demonstrating safety and effectiveness in the target population through clinical monitoring and observation.
   • The document states "clinical data presented in this 510(k) demonstrates the performance of hemodynamic parameters expanded to pediatric patients ≥ 12 years of age... are consistent and within predefined acceptance criteria," implying comparisons to a reference or expected range.

7. The sample size for the training set:

   • Training Set Size: Not applicable/not specified. These devices measure physiological parameters; they are not "AI algorithms" in the sense of needing a large training dataset to learn patterns for classification or prediction (except for the Acumen HPI feature, but no details on its development or training are provided here). The focus of this 510(k) is the application of existing technology to a new age group, not the development of a new pattern-recognition algorithm.

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

   • Ground Truth for Training Set: Not applicable, as there's no mention of a traditional AI training set. The devices likely use established physiological models and algorithms for calculating parameters. If the Acumen HPI feature involved machine learning, its training ground truth would likely be based on recorded physiological data and subsequent hypotensive events. However, the document does not elaborate on the development of this specific feature in the context of this 510(k).

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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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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.

The Swan-Ganz thermodilution Paceport catheters (Model 931F75) are used for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The Paceport catheter (Model 931F75) may also be used for standby temporary ventricular pacing. 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 thermodilution A-V Paceport catheter (Model 991F8) is indicated for the assessment of a patient's hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions. The A-V Paceport catheter (Model 991F8) is also indicated for standby temporary ventricular, atrial, or A-V sequential pacing using the Model D98100 Chandler Transluminal V-pacing probe and/or Model D98500 A-pacing probe. 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 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.

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.

The primary indications for the Swan-Ganz CCO thermodilution catheters include: Acute heart failure, Severe hypovolemia, Complex circulatory situations, Medical emergencies, Adult respiratory distress syndrome, Gram negative sepsis, Drug intoxication, Acute renal failure, Hemorrhagic pancreatitis, Intra and post-operative management of high risk patients, History of pulmonary or cardiac disease, Fluid shifts (e.g., extensive intra-abdominal operations), Management of high-risk obstetrical patients, Diagnosed cardiac disease, Toxemia, Premature separation of placenta, Cardiac output determinations, Differential diagnosis of mitral regurgitation and ventricular septal rupture, Diagnosis of cardiac tamponade. Models with CEDV capabilities are also indicated for volumetric determinations. Secondary indications include the following: Blood Sampling, Infusion of saline and dextrose solutions.

The primary indications for the CCOmbo EDV TD catheters include: Acute heart failure, Severe hypovolemia, Complex circulatory situations, Medical emergencies, Adult respiratory distress syndrome, Gram negative sepsis, Multi system organ failure, Drug intoxication, Acute renal failure, Hemorrhagic pancreatitis, Intra and post-operative management of high risk patients, History of pulmonary or cardiac disease, Fluid shifts (e.g., extensive intra-abdominal operations), Management of high-risk obstetrical patients, Diagnosed cardiac disease, Toxemia, Premature separation of placenta, Cardiac output determinations, Volumetric determinations, Differential diagnosis of mitral regurgitation and ventricular septal rupture, Diagnosis of cardiac tamponade. Secondary indications include the following: Blood Sampling, Infusion of saline and dextrose solutions.

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. The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, 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 REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75 and 759F75, 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 well known pulmonary artery catheters intended for use on critical care patients. A Swan-Ganz Catheter includes an inflatable balloon at the tip, which facilitates its placement into the pulmonary artery through the flow of blood. The catheters can be grouped together based on functionality. The Swan-Ganz catheters can be used with compatible cardiac output patient monitors and/or with oximetry modules (depending on the model number) to transmit signals for hemodynamic pressure monitoring, cardiac output measurements, and/or oximetry measurements. The Swan-Ganz catheters are to be used with the Edwards and/or Edwards' compatible patient monitors, such as the Vigilance II.

The provided document is a 510(k) premarket notification for Edwards Lifesciences, LLC Swan Ganz Catheters. This document outlines the device's indications for use and includes a 510(k) summary (Section 5).

However, it does not contain information regarding detailed acceptance criteria, a study proving the device meets these criteria, sample sizes for test or training sets, expert qualifications, or adjudication methods for AI/software-as-a-medical-device (SaMD) performance evaluation. The document primarily focuses on demonstrating substantial equivalence to predicate devices for its intended physiological monitoring functions and includes an update regarding MRI compatibility.

Therefore, I cannot extract the specific information requested in your bullet points related to acceptance criteria and study details for an AI/SaMD device from this document. The "Key Performance Specifications" section explicitly states: "The proposed contraindication change and the MR Safe claim do not have any effect on the design, materials, technology and operating principles of current legally marketed device. Therefore no additional performance testing was required."

The "Functional/Safety Testing" section mentions: "Swan-Ganz Flow Directed Monitoring catheter was evaluated for MRI compatibility and was confirmed to be MR Safe". This refers to the physical safety of the catheter in an MRI environment, not a performance evaluation in the context of diagnostic accuracy or clinical effectiveness that would typically involve acceptance criteria and comparative studies for a software device.

Without the requested details, I am unable to generate the bulleted list of acceptance criteria and study information.

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