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Output: The Anyra's intended use is for the measurement of Galvanic Skin Response

Galvanic Skin Response Device

The provided text is a 510(k) summary for the Asyra Galvanic Skin Response Device. This document focuses on establishing substantial equivalence to a predicate device and outlines safety features. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the text:

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. The document does not describe a performance study with a test set. It is a 510(k) submission based on substantial equivalence and safety features, not a clinical or performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. There is no mention of a test set or ground truth establishment by experts in this document.

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

• Not applicable. There is no mention of a test set or adjudication.

5. 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. This is a Galvanic Skin Response device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.

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

• Not applicable. This device is for measuring Galvanic Skin Response, which inherently involves human interaction (patient connected to electrodes). It does not appear to be an algorithm-only device in the context of advanced diagnostic interpretation.

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

• Not applicable. The document does not describe a study involving ground truth. The submission is based on substantial equivalence and safety rather than a performance study that requires ground truth.

8. The sample size for the training set:

• Not applicable. The document does not describe a machine learning or algorithm-based device that would require a training set.

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

• Not applicable. The document does not describe a machine learning or algorithm-based device that would require ground truth for a training set.

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