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The Model R is a motor-driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

WHILL Model R is an indoor/outdoor electric scooter that is intended as a mobility aid for elderly persons or persons with reduced mobility. Providing Bluetooth-based radio communications functionalities. Model R is available in two variants, the 3-wheel model and the 4-wheel model. The 3-wheel scooter has a base with metal alloy frame, one front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger. The 4-wheel scooter has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger. The only difference between 3-wheel model and 4-wheel model is front drive-base component. The 3-wheel model has a single front tire, while the 4-wheel model has two front tires. Besides this difference in mechanical design, other parts of the device are identical across the two models. Customers can choose a model depending on their preferences and use case. Model R has a removable lithium-ion battery, a swivel 17-inch-wide seat with two armrests and front and rear LED lights. The battery may be charged either when installed within the device or when removed. Some components are adjustable to provide user with a comfortable riding position. The inner width and the height of the armrests are adjustable in 3 positions. The seat position from the tiller is adjustable in 4 positions. The seat height is adjustable in 2 positions and the tiller angle is also adjustable. A lap belt is equipped for posture support and for safety. As with all conventional powered scooters, to drive the Model R, the user sits in the seat and grips the tiller handle around the controller unit which is positioned in front of the user. While gripping the tiller handle, the user uses their fingers to pull the right side of the throttle control lever gently to drive the device forward. The degree at which the throttle control lever is pulled is positively proportional to the speed of the device. When the throttle control lever returns to its original position after the user releases it, the device decelerates and comes to a stop. When the user uses their fingers to pull on the left side of the lever, the device drives backwards. To move to the left, the user turns the tiller handle to the left, and, to the right, the user turns the tiller handle to the right. Model R has Bluetooth-based radio communications capabilities. The user can power on Model R with a physical key, a Bluetooth smart key fob or with a dedicated smartphone app. The user can select speed profiles, turn off and on the front LED light and sound the audible warning device by operating the controller unit. User can disassemble Model R into four components, i.e. drive base, main body, seat base assembly and battery, without the use of tools when loading into a car for transportation. The device supports a maximum weight of 147 kg (325 lbs.), including the weight of the occupant and any carried items. The 3-wheel model has a theoretical continuous driving range of 18.7 km (11.6 miles) while the 4-wheel model has a theoretical continuous driving range of 17.2 km (10.7 miles).

The provided text is a 510(k) Summary for the WHILL Model R, a motor-driven indoor and outdoor transportation vehicle. It details the device's characteristics, comparison to predicate and reference devices, and results of safety and performance testing to demonstrate substantial equivalence.

However, the provided text does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device performance study.

The document discusses:

• Performance testing of the physical device (e.g., static stability, dynamic stability, braking, electrical safety, biocompatibility) against existing ISO and IEC standards for wheelchairs and motorized three-wheeled vehicles. These are not "acceptance criteria" for an AI/ML algorithm's performance.
• Comparison of technological characteristics between the subject device, a predicate device, and a reference device to demonstrate "substantial equivalence." This is a regulatory pathway for physical medical devices, not a performance study for an AI/ML algorithm.
• Software Verification and Validation Testing according to ANSI AAMI IEC 62304, which is a standard for medical device software lifecycle processes, but doesn't specify performance metrics for an AI/ML model.
• FCC Radio Frequency Testing and Wireless Co-existence Testing for the device's Bluetooth functionalities, which are regulatory compliance tests for wireless communication, not AI/ML performance.
• Usability Testing according to IEC 62366-1, which focuses on user interface and safety, not AI/ML algorithm accuracy.

Therefore, I cannot extract the requested information about AI/ML acceptance criteria or a study proving it, as the provided document does not pertain to the performance evaluation of an AI/ML medical device. It describes the regulatory submission for a physical motorized vehicle.

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