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The Peachtree Proportional Head Control model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods. The first is a non-contact, fully proportional head movement commanded driving control. The next is controlled by a series of blowing and inhaling into a straw. This allows for four way directional control of the wheelchair. The last driving method uses a combination of the two previous drive controls. The user would tilt their had laterally to move the wheelchair left or right and blow or inhale into the straw to control forward/reverse direction/speed.

At current the PHC-3 has only been made to be compatible with Invacare's MKIV series of electronics and Dynamic Controls DX series of electronics.

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The provided text is a 510(k) summary for the Dynamic Systems, Inc.'s PHC-3 (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 performance, sample sizes, ground truth establishment, or expert involvement for a study.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data in the way a clinical trial or performance study report would.

Therefore, I cannot fulfill your request for the specific details you've asked for based on the provided text, as this information is not present in the document.

The document contains the following:

• Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Dynamic Systems, Inc., 5002 North Royal Atlanta Drive, Suite P Tucker, GA 30084, David R. Court, September 15, 1998.
• Name of Device: Peachtree Proportional Head Control Unit (PHC-3)
• Common or Usual Name: Power Wheelchair Control Unit
• Classification: Power Wheelchair Control Unit
• Predicate Devices: Dynamic Systems Inc.'s Peachtree Head Control PHC-2 (K972147), Adaptive Switch Lab's ASL Model #104 (K914737); Invacare's model MCC-MKIV Micro (Sip & Puff and R.I.M.) (K940972); and Invacare's Model #1555 Remote Joystick (K880364).
• Indications for Use: The Peachtree Proportional Head Control model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods:
  1. Non-contact, fully proportional head movement commanded driving control.
  2. Controlled by a series of blowing and inhaling into a straw for four-way directional control.
  3. A combination of the above: lateral head tilt for left/right movement and blow/inhale into a straw for forward/reverse direction/speed control.
  • Compatibility: Invacare's MKIV series of electronics and Dynamic Controls DX series of electronics.

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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.

Ask a specific question about this device