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The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.

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This is a letter about the FDA's decision regarding a 510(k) premarket notification for a powered wheelchair. This type of document, particularly older ones, typically does not contain detailed information about acceptance criteria or specific studies in the way you've outlined for AI/ML devices. The focus here is on substantial equivalence to a predicate device.

Therefore, I cannot provide the information requested in your prompt based on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This document is a regulatory approval letter for a medical device (a powered wheelchair) based on its substantial equivalence to previously marketed predicate devices, not a study report for an AI/ML device.

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