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The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz™ and statepadz II™ Electrodes for connection with Medtronic Physio-Control Defibrillator and data: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable.

The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Statpadz, and Statpadz II Electrodes.

The provided text describes the BIO-DETEK Electrode Adaptor and its 510(k) premarket notification. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Device description and intended use.
• Technological characteristics and compliance with standards.
• The FDA's decision regarding substantial equivalence to a predicate device.
• Indications for Use.

Therefore, I cannot provide the requested information from the given text.

To answer your request, a study report or clinical data section would be needed, which is not present in this 510(k) summary and FDA letter.

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