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The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable, single patient use, only. The M3501A & M3502A electrodes provide the conductive interface between and the defibrillator and/or the external pacing instrument. This device is intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose classified as low power (360 Joule maximum.)

Multifunction Adult Defib. Electrodes Model Numbers M3501A/M3502A

The provided text is a 510(k) premarket notification approval letter for the Hewlett Packard M3501A/M3502A Multifunction Adult Defibrillator Electrodes. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter acknowledges the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use: "external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable defibrillator and/or external pacing electrode." It specifies that the electrodes are for "single patient use, only" and "intended for use on adult patients," connecting to "defibrillators whose stored energy is classified as low power (360 Joule maximum)."

Therefore, I cannot provide the requested information based on the input text. The document is an FDA approval letter, not a study report.

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