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The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electrical muscle stimulators). The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

The Conductive Gel is a colored gel used for reducing the impedance between electrodes and the skin. The gel is to be generously applied to the area under an electrode, which is to be used. The gel can be washed off the skin after use.

This submission describes a Conductive Gel and does not include a study with acceptance criteria, device performance, or human readers as described in your request. The provided text is a 510(k) summary for a medical device (conductive gel) intended for use with TENS and EMS devices.

Therefore, I cannot extract the information required concerning:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established.

This document focuses on demonstrating substantial equivalence to a predicate device (Skylark Batch #6060 Conductive Gel) rather than presenting a performance study with specific acceptance criteria that would apply to software or AI-driven devices. The "study" here is essentially the comparison to the predicate device to argue for substantial equivalence in safety and effectiveness.

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