Calculation population size and analysis of a study comparing two outcomes

Calculation sample size and analysis of a study comparing two outcomes

Hi i'm having difficulty finding an answer to this specific problem.

I'm preparing a pilot study comparing two medical devices.

Each device reads a patient's physiological / laboratory data and provides a recommendation (e.g give intravenous fluid, give medication, give more oxygen).

One device is considered the 'gold standard' and the other is the experimental device.

I wish to conduct a study comparing the experimental device's recommendations with the gold standard (i.e simply, does it agree or disagree). The idea is that this experimental device is cheaper / more cost effective.

The ideal outcome is that the experimental device agrees 100% of the time with the gold standard.

1) How can i calculate the required sample size, to ensure the study is powered adequately?
2) What type of statistical tests can i apply to the data acquired from this?
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