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The PHC-2 is intended to provide mobility control to persons restricted to a seated position while operating a power-drive wheelchair.

The Peachtree Proportional Head Control Unit is non-contact, fully proportional, head movement commanded driving control intended to provide mobility control to persons restricted to a seated position while operating a variety of available power-drive wheelchairs.

The PHC-2 consists of a headrest pad containing a control unit which provides invisible contact between the user and the wheelchair. The control unit is a remote, electronic, two dimensional head position sensing device that utilizes a low level, high frequency electrical field to provide contact between the user and the wheelchair.

The PHC-2 control unit does not require physical attachments to the user. The user simply tilts his or her head to provide control commands to the wheelchair. The PHC-2 has two operational modes: control and drive, the user enters the various modes and functions by gently tapping the head rest a designated number of times. On power up, the unit is always in control mode which includes the following functions: stop, recline, ECU, and drive. The stop function results in no activity, recline allows the user to recline the back of the wheelchair with head motions, and the ECU function controls an environmental control unit, if available. The second level is drive mode which includes: stop, reverse, forward low, and forward high. Within the drive modes the user can accelerate, brake, spin, and turn by utilizing non-contact head movements.

The provided document is a 510(k) summary for the Dynamic Systems, Inc.'s PHC-2 (Peachtree Proportional Head Control Unit). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, study design, or performance data that would be used to prove the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission for premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting detailed performance study results against specific acceptance criteria.

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