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The Trivarion Buffered Iontophoresis Electrode System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The Trivarion Buffered Iontophoresis Electrode System consists of a disposable, single-use iontophoresis electrode and return electrode. A packaged 70% isopropyl alcohol patch (Becton Dickinson, Franklin Lakes, NJ 07417) is also included. The Trivarion lontophoresis Electrode System does not include the iontophoresis electrical generator or the electrical lead wires. Commercially available, FDA approved microprocessor controlled constant current generators such as the lomed phoresor or EMPI Dupel may be connected to the Trivarion electrodes. The Trivarion Iontophoresis Electrode is buffered by the use of silver-silver chloride for administered doses in the range of 40-80 mAmp*min for both polarities, negative and positive.

The provided text is a 510(k) summary for the ActivaTek Trivarion Buffered Iontophoresis Electrode System. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, and mode of operation. Crucially, this document does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in performance testing reports for new medical device functionalities.

The sections below are filled out based on the absence of the requested information in the provided text.

Acceptance Criteria and Device Performance

The provided document does not specify acceptance criteria or report device performance data in the manner typically seen for clinical or analytical performance studies. The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, and mode of operation.

Study Information

The provided document does not describe a specific study designed to prove the device meets acceptance criteria related to its performance beyond demonstrating substantial equivalence to predicate devices. The information presented is typical of a 510(k) submission which relies on comparison to existing legally marketed devices.

1. Sample size used for the test set and data provenance: Not applicable. No test set for performance evaluation is described.
2. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
3. Adjudication method for the test set: Not applicable. No test set adjudication is described.
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 electrode system, not an AI-assisted diagnostic tool for which MRMC studies would be relevant.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an iontophoresis electrode system, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is described.
7. The sample size for the training set: Not applicable. This device is an iontophoresis electrode system, not a machine learning algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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