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The Bruno Electra-Ride Stairway Elevator System, Model SRE-2700, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.

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The provided text is a 510(k) clearance letter from the FDA for the Bruno Electra-Ride, Model SRE-2700, a Powered Patient Transport device. This letter does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the device is "substantially equivalent to legally marketed predicate devices." This means the FDA determined the new device is as safe and effective as another legally marketed device, often without requiring new clinical trials that would generate the kind of detailed performance data you're asking for.

Therefore, I cannot provide a response to your numbered questions based on the input text. The document is solely a regulatory clearance letter, not a study report.

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