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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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