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Intended use is attendant guided transportation for hospital patients. Amigo Mobility International's intent is to supply the above named device to hospital equipment distributors. The device can be operated indoors on carpeting, linoleum, and other floors, and on sidewalks.

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I am sorry, but the provided text from the FDA 510(k) letter for the Amigo Escort 7.5 powered wheelchair does not contain the information requested in your prompt.

The document is a substantial equivalence determination letter, which confirms that the FDA has reviewed the premarket notification for the device and determined it is substantially equivalent to a legally marketed predicate device. It specifies general controls, regulatory class, and lists the indications for use.

However, it does not include details about:

• Acceptance criteria and reported device performance in a table format.
• Sample sizes, data provenance, or details about the test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance studies.
• Type of ground truth used (expert consensus, pathology, outcome data).
• Training set sample size or how its ground truth was established.

This type of information, particularly regarding detailed performance studies, would typically be found in the 510(k) submission itself, which is a much more extensive document than the FDA's decision letter.

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