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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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. 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.

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