Search Results

Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other commercially available iontophoresis devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dupel Iontophoresis Lead Wire Adapter:

Missing Information Disclosure:

It's important to note that the provided documents are a 510(k) premarket notification summary and an FDA clearance letter. These types of documents typically summarize the rationale for substantial equivalence rather than providing a detailed technical report of a clinical study with granular data on acceptance criteria, reader performance, or ground truth establishment. Therefore, much of the requested information (especially quantitative details about studies, sample sizes, and expert qualifications) is not present in the provided text.

Acceptance Criteria and Device Performance:

The document states: "Qualification was performed to establish suitability of performance between Dupel electrodes and lead wire adapters with other commercially available iontophoresis devices." This indicates that the core acceptance criterion was the "suitability of performance" when the Dupel adapter was used with existing devices.

A table of specific numerical acceptance criteria and reported device performance is not provided in the document, as the focus is on substantial equivalence rather than a detailed performance study against pre-defined quantitative metrics.

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document refers to "Qualification" being performed, which is a non-clinical test.
   • Data Provenance: The document does not specify a country of origin for any data or whether it was retrospective or prospective. Given it's a non-clinical qualification, it would likely be laboratory-based testing rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not stated. The "qualification" appears to be a technical, non-clinical assessment of device compatibility and electrical performance, rather than a clinical study requiring expert ground truth in the medical sense.

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

   • Not applicable/Not stated. This is typically relevant for clinical studies with subjective assessments.

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:

   • No MRMC study was done. This device is an iontophoresis lead wire adapter, not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This is not an algorithm-based device. "Qualification was performed to establish suitability of performance" suggests engineering and compatibility testing rather than algorithm evaluation.

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

   • Not explicitly stated, but for a "qualification" of a lead wire adapter, the "ground truth" would likely involve objective engineering and electrical parameters (e.g., conductivity, impedance, physical fit, current delivery consistency) verified against technical specifications or predicate device performance. It would not be medical ground truth like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable/Not stated. No "training set" is mentioned as this device does not involve machine learning or AI.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for AI was used.

Ask a specific question about this device