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Sample size for design verification of variable in single use device

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Firdausom87

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#21
Hi, I am planning to do DV on my product, it consist of an Electronic Controller which will be attached to single use sterile disposable box. Currently planning for Clinical Trial only. Based on the cost, and small build size (probably 50 Electronic Controller and 100 disposable boxes), how to determine the sample size for DV?
 
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