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For Transporting and Isolating a TB patient or a suspected TB patient

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The provided text is a 510(k) summary for a medical device (Failsafe Isolation Systems Transport Model 07 and Portable Isolation Model 77). It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document does not contain details about specific acceptance criteria, study designs, sample sizes, or ground truth establishment for the device itself.

It focuses on regulatory approval based on equivalence to existing devices, not performance criteria from a clinical trial or algorithm validation study. Therefore, I cannot extract the requested information from the provided text.

To answer your questions, I would need a different type of document, such as a clinical study report, a device validation report, or a detailed technical submission describing the performance evaluation.

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