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The Hybresis system is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.

The Empi Hybresis integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, one-application use and can only be used with Empi's Hybresis dose controller. The Hybresis dose controller provides control of the current and therefore dosage delivered.

The Hybresis dose controller is a small, battery-powered, microprocessor-controlled Iontophoresis device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

This document is a 510(k) Summary for the Hybresis Iontophoresis Drug Delivery System. It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the format requested.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically in the context of device performance metrics like accuracy, sensitivity, or specificity, is not present in the provided text.

The document states:

• Non-clinical Testing: "Verification of the Hybresis includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Hybresis includes testing to show the device meets user needs according to marketing requirements." (Page 1)
• Clinical Testing: "No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Hybresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence." (Page 1)

This indicates that the device's acceptance criteria are related to its electrical and mechanical specifications and user needs, which were assessed through non-clinical verification and validation testing. However, the specific quantitative acceptance criteria and the detailed results of those tests are not provided in this summary.

Given the nature of the device (an iontophoresis drug delivery system) and the type of submission (510(k) for substantial equivalence, specifically a modification for naming and contraindications), the focus is on maintaining equivalence to a predicate device rather than proving novel clinical efficacy or diagnostic performance. Therefore, a clinical study as would be seen for an AI/CADe device with metrics like sensitivity/specificity is explicitly stated as not required.

In summary, based only on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance (as no clinical test set is described).
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (as no clinical ground truth assessment is detailed).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document does mention "electrical and mechanical tests" and "validation testing" but does not detail the criteria or results.

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