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The Miniphysionzier 2.0 and Electrodes are intended for use in the iontophoretic transdermal administration of ionized medications.

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The provided text is a 510(k) premarket notification approval letter for the Physionizer 2.0 and Electrodes, an iontophoresis device. It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.

However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, study details (like sample sizes, ground truth establishment, or expert qualifications), or multi-reader multi-case studies. These details are typically found in the 510(k) submission itself, not the approval letter.

Therefore, I cannot provide the requested table and study information based on the given text. The approval letter only confirms the device's classification and substantial equivalence to a predicate device, noting the intended use for iontophoretic transdermal administration of ionized medications.

To answer your questions, I would need access to the actual 510(k) submission document for K022950, which would detail the performance studies and acceptance criteria used to support the substantial equivalence claim.

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