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The Bruno Electra-Ride™, Model Sre-1540 and Electra-Ride™ II, Model SRE-1550, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairliff. 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) premarket notification approval letter for the Bruno Electra-Ride™ Models SRE-1540 and SRE-1550, which are powered patient transport devices (stairlifts). This document focuses on regulatory approval rather than a detailed study evaluating specific acceptance criteria for device performance. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and a study proving those criteria were met.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. The type of ground truth used.
5. Sample size for the training set or how ground truth for the training set was established.

This document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness profiles to existing products on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence.

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