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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 VolumeView 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 Edwards Lifesciences FloTrac and VolumeView sensors are sterile, single use devices that monitors pressures when attached to pressure monitoring catheters. The FloTrac and VolumeView sensors are also capable of providing cardiac output measurements when connect to compatible Edwards monitoring systems.

The provided text describes a 510(k) premarket notification for the FloTrac Sensor and VolumeView Sensor. While it lists performance specifications and mentions functional safety testing, it does not contain a detailed study with acceptance criteria, sample sizes, ground truth establishment, or specific reported device performance data in the way a clinical study report would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K043065 and K142749) through performance testing. The information provided is primarily related to the device's technical specifications and the conclusion that it is safe, effective, and substantially equivalent.

Here's an attempt to extract the requested information based on what is available, noting where information is explicitly not provided:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document states "Performance testing was conducted" and "functional performance testing post MRI exposure" but does not give the number of devices or data points tested.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• This information is not provided. The testing described appears to be technical performance testing against engineering specifications, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

• This information is not provided. As the testing appears to be technical performance validation against specifications, an adjudication method for ground truth in the context of clinical interpretation would not be applicable.

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 device is a sensor for intravascular pressure monitoring and cardiac output measurement. It is not an AI-assisted diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

• The device itself is a standalone sensor. The document states "Performance testing was conducted to compare the proposed device(s) to the predicate device(s)" and "The Flotrac and VolumeView Sensors have successfully passed functional performance testing post MRI exposure. This testing included pressure accuracy (nonlinearity and hysteresis)." This implies standalone technical performance testing of the device.

7. The type of ground truth used

• The "ground truth" for the performance testing described would be the established engineering specifications or reference measurements for pressure accuracy, flush rate, and operating pressure range. For example, a calibrated pressure source would serve as the ground truth for pressure accuracy measurements.

8. The sample size for the training set

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

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

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

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