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Modified star padz Adult Multi-Function Electrodes will be used for the following clinical applications:

• Defibrillation .
• Cardioversion .
• Noninvasive Pacing .
• Electrocardingraph Monitoring ●

In conjuction 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 .

Not Found

This document is a 510(k) premarket notification FDA clearance letter for a medical device called "Modified stat•padz Adult Multi-Function Electrodes." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It lists the intended uses and the types of medical personnel who will use it.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from the provided text. This type of information would typically be found in a separate study report or a detailed submission document, not in the FDA clearance letter itself.

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