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The intended use of the Model-Allure (HP6), powered wheelchair is to provide mobility to adults, weighing up to 350 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

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This document is a 510(k) premarket notification for a powered wheelchair, not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth for an AI/ML device.

Specifically, the document:

• Approves the IMC Heartway Model-Allure (HP6) Electric Power Wheelchair.
• States its intended use and specifications (mobility for adults up to 350 pounds, who can sit themselves and operate a joystick).
• Confirms its classification as a Class II device.
• Refers to substantial equivalence to legally marketed predicate devices.

It does not involve any AI/ML components, and thus, the requested details about acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment for an AI/ML algorithm are not present in this document.

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