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The Dynatron® IBox™ is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

The Dynatron® IBox™ is an iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

The Dynatron® IBox™ is a battery powered, solid state, microprocessor-controlled unit that delivers measured, displayed direct current as defined by the user. Treatment duration is also measured and displayed.

The device connects to any number of existing electrodes cleared for marketing in the United States that have a common snap connection. Device output is functionally identical to predicate devices.

The provided text is a 510(k) premarket notification for the Dynatron® IBox™ Iontophoresis device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving comprehensive clinical effectiveness through studies with acceptance criteria in the manner typically seen for novel devices.

Therefore, the submission does not contain information about specific acceptance criteria for device performance or a study demonstrating the device meets such criteria. Instead, it asserts that the device is "functionally identical to predicate devices" and "substantially equivalent" to them.

Here's why the requested information cannot be fully provided from the given text:

• Acceptance Criteria & Reported Performance: The document does not define specific performance metrics (like accuracy, sensitivity, specificity, etc.) for the Dynatron® IBox™ or report any test results against such criteria. The "performance standards" mentioned refer to 21 CFR section 1010, which states that iontophoresis devices are not designated under performance standards requirements.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all elements of studies designed to assess direct clinical or analytical performance. Since the 510(k) relies on substantial equivalence and states the device is "functionally identical to predicate devices," it does not include new clinical or analytical study data of this type for the Dynatron® IBox™.

Based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics (e.g., accuracy, precision) for this specific device in the submission. The submission relies on "substantial equivalence" to predicate devices and asserts functional identity.
   • Reported Device Performance:
     • "Device output is functionally identical to predicate devices." (Claim)
     • The device "delivers measured, displayed direct current as defined by the user."
     • "Treatment duration is also measured and displayed."

2. Sample size used for the test set and the data provenance: Not applicable. No new clinical or analytical test set or data provenance is detailed for the Dynatron® IBox™ in this substantial equivalence submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new clinical or analytical test set requiring expert ground truth establishment is detailed.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for direct current delivery, not an algorithm.

7. The type of ground truth used: Not applicable. The submission focuses on functional equivalence to predicate devices, not on proving clinical efficacy or diagnostic accuracy with a specific ground truth.

8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or complex analytical models.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a Class III Iontophoresis device seeking clearance based on substantial equivalence. It highlights the device's functional similarity to existing cleared devices rather than presenting new clinical study data with defined acceptance criteria.

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