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The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.

• 1. Provides simultaneous connection to two defibrillators, which allows placement of a set of backup electrodes
• Provides connection to generic physiologic monitor recorder cable for unipolar recording from 2. using a back electrode.
• Used in Hospitals/EP Laboratories
• 4. Used with manual defibrillators and has been tested with the following devices:
     Hewlett Packard CodeMaster Hewlett Packard 7600, 7800 Zoll PD1200, PD1400, "M" Series Siemans 410 PhysioControl LifePak LP5, LP6, LP8, LP9, LP10 and LP 12

The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Booker Box Defibrillation Cable Adapter, Model Pad 5001." This document primarily addresses the substantial equivalence determination for marketing the device and does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies as typically expected for proving a device meets acceptance criteria in a detailed clinical or performance study report.

Therefore, I cannot extract the requested information from the provided text as it is not present in this type of regulatory correspondence. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not elaborate on the specific performance data or studies that might have been submitted by the manufacturer to demonstrate this equivalence.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a performance testing report from the device manufacturer.

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