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The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.

The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.

Here's a summary of the acceptance criteria and the study information regarding the Empi Dupel Transport Iontophoresis System, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. No clinical studies were conducted that involved a "test set" in the context of evaluating a medical device's diagnostic or predictive performance on patient data. Non-clinical testing was performed on the device itself. The text explicitly states: "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."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical studies were conducted that involved human interpretation or a "ground truth" derived from expert consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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 an iontophoresis system, not an imaging or diagnostic AI system that would typically involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical testing" which included "electrical and mechanical tests" and "validation testing...to show the device meets according to marketing requirements." These tests would be considered standalone for the device's functional performance, but not in the context of an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be defined by the device's product specifications and marketing requirements. For example, if a specification states the device must deliver a specific current for a specific duration, the measured current and duration from the device's operation would be compared against that specification.

7. The sample size for the training set: Not applicable. No training set was involved as this is not an AI/machine learning device. The non-clinical tests verified the device against engineering specifications and marketing requirements.

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

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