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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.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Akuport M1," which is a Galvanic skin response measurement device. This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device.

Unfortunately, the letter does not contain the detailed information required to answer your questions about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications. The FDA 510(k) clearance process, especially for devices from 2002, often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance metrics to be submitted within the summary document.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". It does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts or adjudication methods.
• MRMC or standalone study results.
• The type of ground truth used or how it was established.

The "Indications For Use" section clearly states: "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This further suggests that the clearance was based on the device's ability to technically measure galvanic skin response, similar to predicate devices, without needing to establish clinical efficacy or diagnostic accuracy through rigorous performance studies against specific acceptance criteria.

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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

The provided text is a 510(k) clearance letter from the FDA for the "Akuport M-2" device, a galvanic skin response measurement device. This type of document primarily confirms that a new device is "substantially equivalent" to an existing legally marketed device and can therefore be marketed.

It explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

The FDA 510(k) clearance process, especially for galvanic skin response devices, does not typically require or include detailed information about acceptance criteria, performance studies (like those described in your prompt), or analyses of clinical accuracy in the same way a PMA (Premarket Approval) would for high-risk devices or a de novo classification for novel devices.

The document grants clearance based on substantial equivalence, implying the device performs similarly to predicate devices already on the market, not necessarily on specific performance metrics or clinical study outcomes such as accuracy, sensitivity, or specificity against a ground truth.

Therefore, I cannot provide the requested information from the given text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information or effect sizes.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Indications For Use" section states: "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." This further emphasizes the lack of clinical performance claims or studies within this clearance document.

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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 document is an FDA 510(k) clearance letter for the EAV Combi-2 device, a galvanic skin response measurement device. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the kind of detailed information about acceptance criteria or a study proving device performance that you're asking for.

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 regulatory clearance is for the device as a measurement tool, not for any diagnostic or performance claims based on the data it collects.

Therefore, I cannot provide the requested information from this document because it is not present. Here's why:

• Acceptance Criteria & Reported Performance: This information is not found in the 510(k) clearance letter. These are typically part of the 510(k) submission, not the clearance letter itself.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): The document specifically states "There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities." This implies that a study demonstrating "performance" in the way you're asking about (e.g., diagnostic accuracy, reader improvement) was not required or submitted for this particular clearance, as the device is cleared only for measurement of galvanic skin response, not for making diagnoses or providing specific utility of the data.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission document (if publicly available) or a different type of regulatory submission (like a PMA, which requires clinical efficacy data).

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