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ZOLL Superpadz Adult Multi-Function Electrodes will be used for the following clinical applications:

• Defibrillation .
• Cardioversion .
• Noninvasive Pacing .
• Electrocardiograph Monitoring .
  In conjunction with these devices:
• ZOLL PD™ 1200 Pacemaker/Defibrillator .
• ZOLL PD™ 1400 Pacemaker/Defibrillator .
• ZOLL PD™ 2000 Pacemaker/Defibrillator .
• ZOLL D 900 Defibrillator .
• ZOLL D 1400 Defibrillator .
• ZOLL D 2000 Defibrillator .
• ZOLL 1600 Pacemaker/Defibrillator .
• ZOLL 1700 Pacemaker/Defibrillator .
• ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
• ZOLL M Series .

Superpadz Adult Multi-Function Electrodes

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "ZOLL Superpadz Adult Multi-Function Electrode." It's a regulatory document confirming substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market their product.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval letter, not a scientific study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.

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