Search Results

Galvanic Skin Response Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.

Not Found

This letter pertains to a 510(k) premarket notification for the "EAV Kindling 2000s," a Galvanic Skin Response measurement device. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

However, the provided document is a regulatory approval letter from the FDA. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a submission summary or clinical study report. The letter explicitly states: "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This indicates that the device is approved for measuring galvanic skin response, but not for making specific diagnostic claims or for demonstrating clinical efficacy in a way that would require the type of performance metrics usually associated with "acceptance criteria" for diagnostic accuracy.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not available in this regulatory letter. This letter confirms substantial equivalence but does not detail specific performance thresholds or metrics.
2. Sample sizes used for the test set and the data provenance: Not available. The letter does not describe any specific test set or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a galvanic skin response measurement device, not an AI algorithm.
7. The type of ground truth used: Not applicable/available.
8. The sample size for the training set: Not applicable/available.
9. How the ground truth for the training set was established: Not applicable/available.

Conclusion:

This FDA 510(k) approval letter confirms that the EAV Kindling 2000s device is substantially equivalent to a predicate device for its indicated use (measurement of skin resistance to determine autonomic responses) and can be marketed. However, it does not provide any information regarding specific acceptance criteria for performance, study designs, sample sizes, expert involvement, or ground truth establishment, which are typically found in a 510(k) summary or detailed study report. The letter explicitly states no claims are made for the usefulness of the data or specific diagnostic capabilities, suggesting the equivalence was likely based on technical specifications and safety rather than a clinical performance study with defined diagnostic acceptance criteria.

Ask a specific question about this device