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The device JWX-1 PLUS( NAVIGO 24" ) is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

The JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) is an add-on drive for wheelchairs. The JWX-1 PLUS turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility. The device consists of the left/ right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.

The provided text is a 510(k) summary for a medical device (powered wheelchair conversion kit) and does not contain information about the acceptance criteria or study details for an AI/algorithm-driven device that would typically involve a test set, ground truth experts, MRMC studies, or standalone performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against established international standards for wheelchairs and related electrical components. There is no mention of a software algorithm that performs diagnostic or assistive tasks based on image analysis or other data, which would necessitate the criteria and study design outlined in your request.

Therefore, I cannot extract the requested information as it is not present in the provided document.

To fulfill your request, the input document would need to describe a medical device that relies on an AI or algorithm to perform a function (e.g., image analysis for diagnosis, an automated decision-making system) and then provide details about its validation study.

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