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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

WU'S 3-WHEELED NEO SCOOTER, WT-T3D

This document is a 510(k) clearance letter from the FDA for a medical device called "WU'S 3-Wheeled NEO Scooter, WT-T3D". It's a regulatory document indicating that the device has been found substantially equivalent to a predicate device, not a study report or clinical trial summary.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided text.

The document primarily focuses on:

• Device Name: WU'S 3-Wheeled NEO Scooter, WT-T3D
• Regulation Number: 21 CFR 890.3800
• Regulation Name: Motorized three-wheeled vehicle
• Regulatory Class: II
• Product Code: INI
• Indications for Use: "The device is intended for medical purposes to provide mobility to persons restricted to a seated position."
• Regulatory Conclusion: Substantial equivalence to a legally marketed predicate device, allowing the device to be marketed.
• Usage: Over-The Counter Use.

Without a separate study report or clinical data submitted as part of the 510(k) application, it's impossible to provide the detailed information requested in the prompt. This document only confirms regulatory clearance, not the specifics of performance testing.

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