(61 days)
To provide an optional means of mobility for physically challenged people.
TE-787N Mini Shopper
This document is a 510(k) premarket notification letter from the FDA regarding the "TE-787N Mini Shopper" device. It confirms the device's substantial equivalence to a legally marketed predicate device.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter, not a study report or a summary of performance data.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets them based on the provided input. The document does not discuss:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is solely an FDA approval letter for a medical device (specifically a motorized three-wheeled vehicle) based on its substantial equivalence to a predicate device, which implies it meets existing safety and effectiveness standards, but the details of how that was demonstrated through specific performance criteria and studies are not included here.
§ 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).