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The Inflatable Positioning Cushion with Remote Hand Control is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion (a.k.a. ImageAir) allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

The ImageAir Remote Hand Control is a remote control transmitter, utilizing 4 AA batteries. It is utilized in conjunction with an integrated Infrared receiver, located in the Main Control Panel of the Blower Assembly, to inflate and deflate the air cushions. The Remote Control transmitter incorporates a membrane keypad which provides control over the following functions:

• Torso Strap On/Off .
• Head Strap On/Off .
• Height Adjust Up/Down .
• Roll Adjust Left/Right .
• Roll Adjust Level .
• Lower All (Patient Exit) .
  The Blower Assembly incorporates a microprocessor control as an additional safety feature to ensure the valves which regulate air pressure to the various inflatable cushions are operated in the proper sequence. For example, it would be inadvisable to raise or lower the patient when the table locking straps are disengaged. The microprocessor inside the blower box monitors strap status and will not allow the valves which direct air into the height adjustment cushions to be operated until the straps are verified as being locked.

The provided document is a 510(k) Pre-Market Notification for a medical device: "Inflatable Positioning Cushions with Remote Hand Control" (also known as ImageAir). This document outlines the device's description, indications for use, and a statement of substantial equivalence to predicate devices. It does not contain any information regarding clinical studies, acceptance criteria, or performance data comparing the device to a ground truth.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because the document does not contain this type of data.

To clarify, the 510(k) process is primarily a pre-market notification to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It does not typically require the submission of clinical trial data or performance studies in the same way a Premarket Approval (PMA) would. The provided document focuses on descriptions, intended use, and a comparison to existing, similar devices to establish this substantial equivalence.

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