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The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited to, post-major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, stroke, and cardiac disease including heart failure.

The Swan-Ganz bipolar pacing catheters are indicated for use in surgical and/or critically ill cardiac patients who may benefit from temporary, transvenous right ventricular pacing.

The Chandler transluminal V-pacing probe is a transluminal bipolar pacing probe, which must be used with a Swan-Ganz Paceport catheter is indicated for use in adult surgical and/or critically ill cardiac patients. This includes, but is not limited to, patients with arrhythmias, acute myocardial infarction, cardiac surgery and coronary angiography.

The Swan-Ganz Pacing Catheters and Pacing Probes are a series of specialized catheters and pacing probes, which are temporarily inserted into the central circulatory system vasculature to facilitate temporary atrial, ventricular, or A-V sequential pacing and to serve as diagnostic and/or therapeutic tools. The catheters may be used to overdrive suppression of arrhythmias and diagnosis of complex arrhythmias. The pacing catheters and probes may be used for ECG detection during placement but are not intended to be used for ECG monitoring.

I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML powered medical device. The document is a 510(k) summary for a set of physical medical devices (catheters and pacing probes) and does not mention any AI or machine learning components.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The document focuses on the substantial equivalence of the Swan-Ganz Pacing Probe and Catheters to predicate devices based on design, material, chemical composition, principle of operation, and compliance with biocompatibility and bench testing standards.

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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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The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes:

• 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

Secondary indications include the following:

• Blood Sampling
• Infusion of saline and dextrose solutions

Intended Use- Swan-Ganz IQ catheter:
The Swan-Ganz IQ catheter (model AIQSGF8) is for use in patients who require hemodynamic monitoring. It is intended to be used in combination with clinical pressure monitoring, equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to measure intermittent cardiac output. Model AIOSGF8 also measures mixed venous oxygen saturation.

The Edwards Swan-Ganz catheters are used to monitor the hemodynamic status of critically ill and injured patients. The existing 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 and pressure transducers.

The Edwards Swan-Ganz product line is comprised of Standard (Base) and Advanced Technology monitoring catheters. The standard 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.

The subject Swan-Ganz IO catheter combines from the existing Advanced catheter design (model 777F8) and the Paceport catheter design (model 780F75M). Using the 777F8 model as the base design, the new catheter modifies the design to remove the thermal filament functionality and replaces it with an additional port which will allow for pressure monitoring at the right ventricular level. The RV port is utilized just like the Swan-Ganz Paceport Oximetry catheter model 780F75M.

Just like the existing advanced catheters, the Swan-Ganz IQ catheter provides the same functionality as the standard and Advanced Technology Swan-Ganz catheters by providing the ability to continuously monitor the patient's balance between oxygen delivery and consumption as well as the ability to help investigate the root cause of an imbalance through analysis of the components of stroke volume (preload, afterload, and contractility).

The provided text is a 510(k) summary for the Edwards Lifesciences Swan-Ganz IQ Pulmonary Arterial Catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT for an AI/ML device. It describes a physical medical device (a catheter) and its modifications. Therefore, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or human-in-the-loop improvement) is not applicable here.

The document discusses "functional and performance testing" which are typical for physical medical devices, such as:

• Packaging, shelf life, sterilization, biocompatibility
• Bench testing:
  • Frequency response testing
  • Pressure tubing pull testing
  • Lumen burst pressure testing per ISO 10555-1:2013 and IEC 60601:2015 Amd.1:2020.

The conclusion states that "Completion of all performance verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications." This refers to engineering and safety specifications of a physical device, not the performance of an AI algorithm on a dataset.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) because the device described in this 510(k) summary is a physical catheter, not an AI/ML diagnostic tool.

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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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The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.

The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.

This document does not contain information about a study proving that a device meets acceptance criteria, an AI/ML device, or a standalone algorithm.

The document is a 510(k) summary for the Percu-Pro™ Messenger Balloon Catheter, which is a physical medical device (a catheter). The summary details its design, intended use, and comparison to predicate devices to establish substantial equivalence, rather than providing performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI system.

Therefore, I cannot provide the requested information.

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Hospira Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions.

Hospira Critical Care Catheters;

Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvQ2), and access ports for drug delivery or blood sampling. In addition, the Hospira Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the balloon.

The provided document is a 510(k) summary for Hospira Critical Care and Advanced Sensor Catheters. It describes the device, its intended use, and a comparison to a predicate device.

However, it does not contain detailed information about specific acceptance criteria and the comprehensive study results that would typically prove a device meets those criteria.

The document states:
"The Hospira Critical Care and Advanced Sensor Catheters have been tested for biocompatibility and for expansion symmetry, over inflation, multiple inflations, deflation time, and burst strength and have passed all of the acceptance criteria." (page 2)

This is a high-level summary and does not provide the quantitative acceptance criteria or the reported device performance in a table format, nor does it detail the specifics of the study, such as sample sizes, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fully complete the requested table and study details based solely on the provided text. The following is extracted from the available information, with specific limitations noted for the missing data.

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document provides a high-level statement that tests were passed but does not specify quantitative acceptance criteria or detailed reported device performance for each test.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified, but generally, medical device testing for regulatory submission like this would be conducted in a controlled lab or manufacturing environment. It is not patient or country-specific data in the clinical sense. This type of testing is typically prospective for engineering and material performance.

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

• Number of Experts: Not applicable. These tests appear to be engineering and material performance tests, not clinical evaluations requiring expert interpretation of results like medical imaging. The "ground truth" would be established by the physical/chemical properties and design specifications of the device.
• Qualifications of Experts: Not applicable for the type of testing described (biocompatibility, mechanical performance). These tests are typically performed by engineers, quality control specialists, and lab technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests described (biocompatibility, mechanical tests) yield objective pass/fail results based on predefined engineering or regulatory standards, rather than requiring subjective adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on manufacturing methods, materials, and functional performance tests of the device itself, not on the interpretation of results by human readers with or without AI assistance. This device is a catheter, not an AI diagnostic tool.
• Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone (algorithm only) performance study was not done. This device is a physical medical catheter, not an algorithm or AI product.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance relies on engineering and material specifications, and validated test methods. For example, the burst strength is compared against a pre-defined safety margin derived from engineering principles and regulatory guidelines for medical devices. Biocompatibility would be assessed against ISO standards (e.g., ISO 10993).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI model. For the device itself, the "ground truth" for its design and manufacturing is established through design specifications, material characterization, and adherence to quality systems and regulatory standards (e.g., Good Manufacturing Practices).

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The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also all ws for sampling of venous blood.

The Continuous Cardiac Ouptut Pulmonary Artery Catheter, (truCATH), is a six lumen heparin coated, polyvinyl chloride (PVC) flow directed Pulmonary Artery Catheter. Once placed the proximal extensions of the catheter are attached to the second part of the system, the monitor. The Continous Cardiac Output Monitor, (truCCOM), is a microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output. The monitor calculates cardiac output based upon a thermodynamic principle of heat transfer using thermal power produced by the termal coil area on the Catheter. Alternatively the monitor can also be used by the clinician to measure cardiac output intermittently through using the injectate capabilities of the catheter.

The provided text describes a 510(k) summary for a Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system. The submission focuses on modifications to a previously cleared device, asserting substantial equivalence. However, the document does not present comprehensive acceptance criteria or detailed study results in the format requested.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily states that testing "confirmed the modified device met or exceeded the same specifications as that of the predicate device." It does not provide explicit, quantifiable acceptance criteria (e.g., accuracy within X%, precision within Y%) or specific performance metrics for the new device. It only refers to matching the predicate device's performance.

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

• Test Set Description: The document mentions "In-vivo testing in Swine Models" and "In-vitro testing in Right Hand…Circulatory System."
• Sample Size: The exact number of swine models or in-vitro tests is not specified.
• Data Provenance: The studies were conducted as part of the device modification and submission, indicating they are prospective studies for this specific submission. The country of origin for the studies is not explicitly stated beyond the company being in the UK.

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

This type of information is not provided in the document. The studies mentioned (in-vitro and in-vivo) would typically involve engineering and animal care/veterinary expertise, but the document does not detail how specific "ground truth" for the device's output was established or if human experts were involved in interpreting results in a way that aligns with typical "ground truth" establishment for diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods are typically used in clinical trials involving human interpretation of diagnostic results, which is not the primary focus of the described in-vitro/in-vivo engineering-focused testing here.

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:

This information is not applicable and not provided. This device is a medical monitor and catheter system, not an AI-powered diagnostic imaging tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document describes the "Continuous Cardiac Output Monitor, (truCCOM)" as a "microprocessor based computer which when interfaced with the truCATH, continuously calculates and displays cardiac output." This implies a standalone algorithm performance as its primary function is to calculate and display cardiac output. The in-vitro and in-vivo testing described would be assessing this standalone algorithm's accuracy and performance.

7. The Type of Ground Truth Used:

For the in-vitro and in-vivo testing, the "ground truth" would likely be derived from:

• Reference standards/measurements: In the in-vitro circulatory system, this would involve highly accurate, established methods for measuring flow, temperature, and other physiological parameters that the device is designed to assess.
• Physiological measurements in swine models: In-vivo (swine models), ground truth would be established using reference methods for cardiac output measurement (e.g., thermodilution with known injectate volumes, direct flow measurement techniques, or other validated invasive methods) against which the truCCOM's continuous output is compared.

The document does not explicitly detail these reference methods, but they are implied by the nature of the testing.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The device is an updated version of a previously cleared device, focusing on "User Interface Improvements," "Re-formatting of history files," "analogue output," "updated equation for the calculation of cardiac output," and "Optimization of system response." This is not a machine learning or AI device that typically involves a distinct "training set" in the context of deep learning. The "updated equation" and "optimization of system response" would have been developed based on engineering principles and potentially previous data, but not in the sense of an ML training set.

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

This information is not applicable as there is no mention of a distinct "training set" for a machine learning model. The ground truth for the device's underlying principles (thermodynamic principle of heat transfer) would be established through scientific research, physics, and empirical data collected during development and previous iterations of the device.

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The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device (Occlusion Balloon Catheter, Model Venos™). It does not contain information about acceptance criteria and a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The letter only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance metrics or studies used to demonstrate that equivalence.

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