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The Vigilance CCO/SvO2 Monitor is intended to measure both bolus/injectate and continuous cardiac output in addition to mixed venous oxygen saturation. The system also calculates hemodynamic and oxygenation parameters.

The Vigilance CCO/SvO2 Monitor is a microprocessor-based instrument which. when connected to a Baxter thermodilution catheter, measures mixed venous oxygen saturation and cardiac output both continuously (CCO) and by the intermittent bolus (injectate) method (ICO). The Vigilance monitor measures cardiac output continuously by injecting small pulses of electrical power into the blood and recording the corresponding blood temperature changes via the catheter. The software based CCO algorithm within the monitor converts these power and blood temperature measurements into an estimate of cardiac output.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Baxter Vigilance CCO/SvO2 Monitor:

No acceptance criteria or study results are explicitly detailed in the provided text in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal study with detailed acceptance criteria and performance metrics for a novel device.

The document states: "Bench testing was performed to show that the software requirements were met and that the modified Vigilance CCO/SvO2 Monitor performs comparably to the unmodified (predicate) device." and "The results of the bench testing demonstrate that the modified Baxter Vigilance CCO/SvO2 Monitor meets the performance requirements and its performance is comparable to the predicate device." However, the specific performance requirements or acceptance criteria (e.g., "accuracy within X%," "reproducibility less than Y standard deviation") are not listed. The "reported device performance" is summarized as being "comparable to the predicate device" and "meets the performance requirements," without providing quantitative data.

Therefore, many of the requested fields cannot be directly extracted from the provided text because it does not contain the detailed study design, acceptance criteria, and quantitative performance results typically found in a comprehensive clinical or validation study report.

Below is an attempt to populate the table and answer the questions based on the inference and limited information available in the text, highlighting where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

A full, detailed study would include specific performance metrics like:

• Accuracy: Mean difference (bias) and limits of agreement with a reference method (e.g., intermittent bolus thermodilution or Fick principle).
• Precision/Reproducibility: Standard deviation or coefficient of variation of repeated measurements.
• Response Time: Time to detect and display changes in cardiac output within a certain percentage.
• Drift: Deviation over time.

None of these quantitative criteria or results are present in the summary.

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

• Test Set Sample Size:
  • Bench Testing: Not specified (e.g., number of test conditions, runs, data points within the "hydro flow model system").
  • Animal Testing: Two sheep.
• Data Provenance: Not specified (e.g., country of origin). Both bench and animal testing appear to be internal evaluations.
• Retrospective/Prospective: Not specified, but animal testing would be considered prospective for the data collection in those animals. Bench testing is generally controlled experimental setup.

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

• Not applicable / Not mentioned. The described testing (bench and animal) does not involve human experts establishing ground truth in the way a diagnostic imaging study would. The comparisons were against the predicate device's performance or expected physical/physiological responses.

4. Adjudication method for the test set:

• Not applicable. No human experts were involved in adjudicating the ground truth for the test sets described.

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. This was not an MRMC study. The device is a monitor that provides a measurement; it does not involve human readers interpreting images or data that would be assisted by AI in the context of this 510(k) summary.

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

• Yes, implicitly. The bench and animal testing evaluated the performance of the modified CCO algorithm and the monitor's readings independently of a human operator's interpretation or intervention, beyond connecting the device and observing its output. The 510(k) focuses on the algorithm's performance within the monitor.

7. The type of ground truth used:

• Bench Testing: The ground truth for bench testing was likely based on known inputs or established reference measurements within the "hydro flow model system" and comparisons to the predicate device's performance.
• Animal Testing: The ground truth was the physiological state of the animals, with the comparison being to the predicate device's performance or "as required" for STAT and trend CCO estimates. A true "gold standard" reference method for continuously monitoring cardiac output in vivo is not explicitly mentioned as being used for comparison (e.g., flow probes, direct Fick measurement), but rather the focus is on the modified algorithm performing "as required" and comparably to the predicate.

8. The sample size for the training set:

• Not mentioned. The document describes modifications to an existing algorithm. It does not provide details on the development or training of the original or modified CCO algorithm. The focus is on demonstrating the performance of the modified algorithm.

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

• Not mentioned. As the sample size for the training set is not provided, neither is how its ground truth was established.

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