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The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.

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The provided text is related to the FDA clearance of a TENS device (Sportstim Model 2.0 TENS Device, K962951). However, it does not contain any information about acceptance criteria, device performance studies, or clinical trial specifics as requested.

The document is a clearance letter stating that the device is substantially equivalent to predicate devices and can be marketed. It discusses regulatory classifications, general controls, and contact information for compliance.

Therefore, I cannot provide the requested information based on the given text. The text does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This is a regulatory clearance document, not a study report or clinical evidence summary.

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