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IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

IontoDC is a bench-top, battery powered, microcontrollercontrolled 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.

This 510(k) premarket notification describes the IontoDC, an iontophoresis device. The review of the provided document indicates that the submission focuses on demonstrating substantial equivalence based on technological characteristics and performance testing against predicate devices, rather than a clinical study evaluating the device's efficacy in treating a specific condition or detecting a disease. Therefore, many of the requested items related to clinical studies, such as sample sizes for test and training sets, expert qualifications, and comparative effectiveness studies, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IontoDC device are implicitly the electrical output parameters and safety standards of the predicate devices and relevant IEC standards. The document outlines a comparison of the IontoDC's parameters with two predicate devices: Dynatron® ibox (primary) and ActivaDose II (reference).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. The submission relies on bench testing and compliance with international standards (IEC 60601-1, IEC 60601-1-2) for electrical output parameters and EMC, and software verification and validation. There is no clinical test set mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. There was no clinical test set requiring expert consensus for ground truth. The "ground truth" for this device's performance is compliance with established electrical and safety standards, as measured by engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set.

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 is a hardware device (iontophoresis device), not an AI/imaging diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This device is not an algorithm. Bench testing evaluated the device's performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for demonstrating substantial equivalence for this device is based on:
  • Compliance with recognized electrical safety and EMC standards: IEC 60601-1 (medical electrical equipment general requirements for basic safety and essential performance) and IEC 60601-1-2 (medical electrical equipment electromagnetic compatibility).
  • Bench testing measurements: Direct comparison of the electrical output parameters of the IontoDC device against those of the predicate devices.
  • Software verification and validation: As per FDA guidance for a "Moderate" level of concern software.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/imaging device. The device's design and manufacturing processes are likely informed by engineering principles and iterations, but not a data-driven training set in the typical AI sense.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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