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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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