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The intended use of the Model SE 01 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Model SE 01, Four Wheel Electric Scooter

I am sorry, but based on the provided document, I cannot describe the "acceptance criteria and the study that proves the device meets the acceptance criteria."

The document is a 510(k) clearance letter from the FDA for a "Sunpex Technology Company, LTD. Model SE 01, Four Wheel Electric Scooter." This letter states that the device is "substantially equivalent" to legally marketed predicate devices.

The document does not contain any information about:

• Specific acceptance criteria for device performance.
• Details of any study (test set, ground truth, expert qualifications, adjudication, sample sizes, training set, etc.) that would prove the device meets performance criteria. The 510(k) process is primarily about demonstrating substantial equivalence to a predicate device, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria, especially for a motorized scooter.

Therefore, I cannot fulfill your request for the table or the study details.

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