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The SudoScan system is a medical device for the measurement of galvanic skin responses.

SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.

SUDOSCAN device is composed of:

• -> The analog acquisition electronic circuitry with low-noise front end
• → The multiplexing control unit for selecting the appropriate acquisition channels
• -> The signal formatting and processing capabilities

• The optically isolated USB interface controller

• -> The power converter,

• The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.

The provided 510(k) summary for the Impeto Medical SUDOSCAN device focuses on demonstrating substantial equivalence to a predicate device (EDX Epi-Scan) for the measurement of galvanic skin response. It does not contain information about clinical studies with specific acceptance criteria that demonstrate device performance against a defined ground truth in a clinical context.

Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a study designed to meet such criteria. It focuses on comparing the technical specifications of the SUDOSCAN to its predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not mentioned. The document refers to "verification of specifications and validation, including software validation," but does not detail a clinical test set or its sample size.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not mentioned, as a clinical test set with ground truth established by experts is not described.

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

• Not mentioned, as a clinical test set with ground truth is not described.

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:

• Not performed or mentioned. The SUDOSCAN device measures galvanic skin response and does not involve human readers interpreting images or data where AI assistance would be applicable in the context of an MRMC study. It is an objective measurement device.

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

• The device performs a standalone measurement of galvanic skin response. The "study" mentioned is "verification of specifications and validation," which implies technical performance rather than clinical performance against a diagnostic endpoint. No clinical standalone performance metrics (e.g., sensitivity, specificity) are reported.

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

• Not mentioned. For a device measuring galvanic skin response, ground truth would typically refer to the accuracy of the measurement itself against a known standard or a biological correlate. The document states "SUDOSCAN device is able to obtain measurements from a larger area at one time whereas EDX Epi-Scan obtains the measurements by taking several measurements over a period of time and then averaging the data," implying the "truth" is the physiological measurement.

8. The sample size for the training set:

• Not mentioned. This device does not appear to use a training set in the sense of machine learning/AI for diagnostic classification. It is a measurement device.

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

• Not applicable/Not mentioned, as no training set or its ground truth establishment is described.

Summary of what is available from the document:

The provided 510(k) summary focuses on demonstrating the technical equivalence of the SUDOSCAN device to its predicate, EDX Epi-Scan, for the purpose of measuring galvanic skin response. It highlights similarities in their intended use, measurement principles, and compliance with electrical safety and EMC standards. The "study" referenced is primarily non-clinical testing, including "verification of specifications and validation, including software validation," rather than a clinical study evaluating diagnostic performance against established acceptance criteria using a ground truth.

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