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The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

The subject device is an update to the existing previously cleared WHILL Model M (K153543). The WHILL Model C2 is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It consists of four parts: seat system, braking system, and drive system. It consists of two motors drive systems, an electromagnetic braking system, an electric motor controller, and a lithium-ion battery with an off-board battery charger. The wheelchair is powered by a 25.3V DC 10.6A rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger.

The control system, including the directional controller (joystick), is equipped on the control pad that attaches to the armrest. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

As with all commercially available powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the seating to fit the user's body. Like the predicate device WHILL Model M, the two side-arms can be rotated out of the way to make it easier for the user to get into and out of the device.

Model C2 also contains Bluetooth-based RF wireless technology. The wireless technology is identical to the legally marketed reference device 2, e-motion-M25 (K192618). The device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. (Note: For safety, Joystick control is priority over the remote control by design.) The smartphone app can also view the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key fob.

The device supports a maximum weight of 136Kg (300lbs.), including the weight of the occupant and any carried items. It has a maximum driving range of 11miles (18km) with a maximum speed limit of up to 5mph (8km/h).

The provided document is a 510(k) Summary for the WHILL Model C2 powered wheelchair, seeking to demonstrate its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain information related to a study proving the device meets acceptance criteria for an AI/algorithm-driven medical device.

Instead, it details the safety and performance testing conducted on the powered wheelchair itself, based on harmonized standards (ISO, IEC, RESNA, etc.), biocompatibility testing, electrical safety, electromagnetic compatibility, and software verification/validation for the control system of the wheelchair. It is a submission for a physical medical device (powered wheelchair), not an AI/algorithm-driven diagnostic/assistive tool.

Therefore, I cannot extract acceptance criteria and study details for an AI/algorithm-driven device from this document. The document describes:

• Device: WHILL Model C2 (a powered wheelchair)
• Purpose of Submission: Demonstrate substantial equivalence of the WHILL Model C2 to predicate and reference powered wheelchairs.
• Testing: Performance tests for wheelchairs (e.g., stability, braking, speed, energy consumption, obstacle climbing, static/impact/fatigue strengths, climatic tests, power/control systems), biocompatibility, electrical safety, EMC, software V&V, FCC RF testing, wireless coexistence testing, and usability testing.
• Ground Truth: For the physical device, "ground truth" is established by adherence to recognized international and national standards (such as ISO 7176 series, IEC 62133-2, ISO 10993, IEC 60601-1-2, ANSI C63.27-2017, etc.). The "results" are typically "Pass" or "Fail" against the requirements of these standards.
• Sample Size: The sample size for testing is implicitly "a sample" of the physical devices, as is typical for medical device regulatory submissions for hardware. Specific numbers are not provided, as the focus is on compliance with standards.
• Experts: Not explicitly stated for each test, but compliance to standards usually involves certified testing labs and engineers with expertise in the relevant standards.
• Adjudication Method: Not applicable in the context of physical product testing against standards.
• MRMC/Standalone AI Study: Not applicable as this is not an AI/algorithm-driven diagnostic or assistive device in the sense typically associated with these types of studies (e.g., for image analysis AI). The "smartphone app" mentioned controls the physical movement of the wheelchair and views status; it's a control interface, not an AI performing medical analysis.
• Training/Test Set for AI: Not applicable for this type of device submission.

In summary, the request for acceptance criteria and study data for an AI/algorithm-driven device cannot be fulfilled by this document as it pertains to a physical powered wheelchair, not an AI medical device.

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