(81 days)
The intended use of the Segaego 4D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.
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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Scooter Segaego 4D," classifying it as a motorized three-wheeled vehicle. It primarily discusses regulatory classification, substantial equivalence to a predicate device, and general controls provisions.
There is no mention of:
- A table of acceptance criteria or reported device performance metrics.
- Sample sizes or data provenance for a test set.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Types of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set or how its ground truth was established.
This document pertains to the regulatory clearance process for a medical device (a scooter), not a study evaluating its performance against specific acceptance criteria for a diagnostic or AI-driven aid.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).