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The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function. SUDOSCAN is indicated for use in the general adult population.

SUDOSCAN is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN devices use both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements. The SUDOSCAN system is composed of: - analog acquisition electronic circuitry with low-noise front end - multiplexing control unit for selecting the appropriate acquisition channels - optically isolated USB interface controller - power converter - 4 electrodes placed on the feet and the hands - touch-screen computer running the proprietary SUDOSCAN software

The provided text is a 510(k) Summary for the SUDOSCAN device (K141872). It compares the proposed device to a predicate device (K100233), which is itself an earlier version of the SUDOSCAN.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new clinical study. Instead, it argues for substantial equivalence based on technological characteristics and a change in indication statement and labeling compared to its own predicate device. The performance data section refers back to the testing provided in the K100233 submission.

The "Performance Data" section states: "The modifications that are the subject of this 510(k) are to the indication statement, labeling and minor software and hardware upgrades. Therefore the performance testing provided in K100233 is applicable to this 510(k)."

This implies that the performance of the device, in terms of its ability to measure galvanic skin response, is considered unchanged from the predicate and thus already "meets acceptance criteria" from its previous clearance. The acceptance criteria would have been established during the K100233 submission.

The table below summarizes the technological characteristics of the proposed device as presented in the "Device Comparison Table" within the document, rather than specific performance metrics from a new study designed to meet pre-defined acceptance criteria for this 510(k).

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

The document for K141872 explicitly states that no new performance testing was conducted for this submission (K141872) related to the device's ability to measure galvanic skin response. It relies on the performance testing from the predicate device (K100233). Therefore, information on a "test set" and "data provenance" for this specific 510(k) application is not provided as new clinical performance data was not generated.

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

As no new clinical performance testing was conducted for K141872, this information is not available in the provided document. The original ground truth establishment would have occurred for the K100233 submission.

4. Adjudication method for the test set

Not applicable, as no new clinical test set and associated performance evaluation were conducted for K141872.

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 applicable. The SUDOSCAN device is a diagnostic measurement device for sudomotor function, not an AI-assisted interpretation tool for images or other complex data requiring human reader interaction in the way a MRMC study typically evaluates. No MRMC study is mentioned or relevant to this device's function.

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

The device itself is a standalone measurement system. The document does not describe "algorithm only" performance in the context of interpretation or diagnosis being done without human involvement. The device measures galvanic skin response, and a physician interprets the results. The statement "Used to provide feedback to physicians, not to diagnose" reinforces the human-in-the-loop aspect for diagnosis, but the measurement itself is standalone. The performance testing for K100233 would have established the accuracy of these standalone measurements.

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

Given that the device measures galvanic skin response, which is a physiological parameter, the ground truth for the original K100233 submission would likely have involved:

• Reference standards for conductivity measurements: Calibration against known electrical standards.
• Correlation with clinical conditions: For its intended use in assessing sudomotor function, the ground truth would have been established by comparing SUDOSCAN measurements with other validated methods for assessing sudomotor function or with clinical diagnoses of conditions affecting sudomotor function, possibly including expert clinical assessment or other established diagnostic tests.
• The provided document for K141872 does not specify the ground truth methodology for K100233.

8. The sample size for the training set

Not applicable. The document describes a 510(k) submission for an existing device with minor changes and expanded indications, relying on the previous clearance. It does not discuss a "training set" in the context of machine learning model development.

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

Not applicable, as this submission does not involve a machine learning model requiring a training set with established ground truth.

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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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