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The contOR® Table Surface is intended to be used on existing operating room table in all surgical procedures to greatly reduce the likelihood of complications as a result of placement on the operating table surface, such as:

• pressure ulcers (pressure relief)
• tissue compromise (positioning)

The contOR® Table Surface is intended to be used to support and position the patient and to provide warming and cooling during surgery. The surface will greatly reduce the likelihood of complications as a result of placement on the operating table surface such as:

• Pressure ulcers
• Tissue compromise

The control unit is a self-contained unit requiring only input of the local power system. The control unit contains the heat exchanger used to heat/cool the medium. In addition, the controi unit contains a pressure/vacuum pump and valve network for Inflating the positioning air bladders and deflating the beaded vacuum bags. The control unit also contains all the controls required to manipulate and monitor the previously mentioned subsystems as well as any other subsystems that might be required for the patient and/or table surface pad while being used in the O. R. Suite. The control unit, which utilizes membrane switch technology and LED screen display the functions of the contOR® Table Surface. Additionally there is a remote pendant that is wired to the control unit that performs the same functions as the main control unit's screen.

The mattress set of the contOR® Table Surface Unit is designed to be used on different operating room tables in lieu of the standard mattress set. The mattress is 21 Inches wide, 72 to 84 inches long and 4 inches high. All aspects of the OR table surface pad are as modular in design as possible to facilitate serviceability and repair. The OR surface pad consists of 3 sections: a head section, a main body section, and a footleg section. The OR surface pad is a multi-ply system contained in an outer cover. The outer cover material has bi-directional stretch and is a nylon web substrate with urethane laminated on both sides. This outer cover will be cleanable throughout the life of the product using standard Hospital disinfectants that are alcohol or phosphate detergent based. The multi-ply system contained in the outer cover consists of several different layers.

The contOR® Table Surface pads are interconnected using Colder fittings for air, vacuum and water supply. Each section is secured to the OR table by longitudinal Velcro strips placed down the center of the under surface each section.

This appears to be a 510(k) summary for the Hill-Rom contOR® Table Surface, a medical device intended for use on operating room tables. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• Device identification: Names, submitter, contact information.
• Predicate devices: Devices used for comparison to establish substantial equivalence.
• Device description: Details about the control unit and mattress set.
• Indications for use: Preventing pressure ulcers and tissue compromise, and providing warming/cooling.
• Comparison to predicates: Highlighting differences in design, but stating they don't significantly affect safety and efficacy.
• FDA clearance letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, I would need a different document that details the performance study and its results against specific acceptance criteria.

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