(69 days)
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 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:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study information or effect sizes.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- 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.
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.