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The Proasia L4501 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Proasia L4501 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text is a 510(k) summary for the Proasia L4501 scooter. This document focuses on establishing substantial equivalence to a predicate device (Bewell SC 20) and does not contain information about studies proving the device meets specific acceptance criteria in the context of AI/ML performance.

The document discusses:

• Device identification: Proasia L4501 scooter.
• Intended use: Provides transportation for disabled or elderly persons limited to a seated position, for indoor/outdoor use.
• Device description: Battery-operated, controlled by a tiller handle and thumb-operated potentiometer throttle.
• Substantial equivalence: Claimed to be substantially equivalent to the Bewell SC 20 (K043326) with minor performance differences not altering function, use, safety, or effectiveness.

Therefore, I cannot provide a response to your request, as the provided text doesn't contain the necessary information regarding acceptance criteria or the study details you've outlined, which are typically relevant for AI/ML device performance evaluations. This 510(k) pertains to a physical medical device (an electric scooter) and its regulatory clearance based on substantial equivalence, not an AI/ML algorithm.

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