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iStim S2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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The provided FDA letter for K181849, "iStim S2 OTC Pain Relief TENS," does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond its substantial equivalence to a predicate device.

This document is a 510(k) clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This determination is primarily based on the device having the same intended use and similar technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the requested information as it is not present in the provided text.

Here's why the document doesn't contain this information and what type of document would:

• 510(k) Clearance Letter: This letter confirms that a device has completed the 510(k) premarket notification process and can be marketed. It's a regulatory decision, not a detailed scientific study report.
• Clinical Study Report or Performance Study Summary: To find information on acceptance criteria, test set details, ground truth establishment, expert qualifications, and actual performance data, one would typically need to review the actual 510(k) submission document, specifically the sections related to performance testing, clinical data (if any was submitted), or bench testing. These submissions are much more extensive than the clearance letter.

In summary, none of the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone performance, ground truth types, training set details) is available in the provided text.

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