(118 days)
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.
Not Found
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.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).