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SudoPath is a Galvanic skin response measurement device. The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

SudoPath is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 2 reusable cables to connect the box to electrodes and 4 tactile electrodes placed on the sole of the feet and on the palm of the hands. Software installed on a computer. As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The provided document is a 510(k) Premarket Notification for the SudoPath device, a Galvanic Skin Response (GSR) measurement device. It details the device's characteristics and compares it to a previously cleared predicate device (EIS-GS).

However, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of AI/ML or comparative diagnostic performance.

Here's why and what information is missing:

• Type of Device: The SudoPath is described as a hardware device (with an electronic box, cables, and electrodes) and accompanying software for measuring galvanic skin response. This is a measurement device, not a diagnostic AI/ML system that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or reader improvement.
• Focus of the 510(k) Summary: The summary focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved by showing that the SudoPath has the same intended use, similar hardware, and the same fundamental scientific technology as the predicate device. The "modifications" listed (change of trade name, removal of two frontal electrodes, and changes in software for number and sequence of measurements) are presented as minor and not affecting safety or effectiveness.
• "Performances and Effectiveness" Section: This section only lists:
  1. New risk management (generic for medical devices).
  2. Software verification (SRS/SDS/STD/STR - standard software development lifecycle documentation).
  3. Summary of Design Control Activities and Declaration of Design control conformity (again, standard quality system requirements).
     None of these refer to clinical performance studies, AI/ML model performance metrics, or human reader studies.
• Substantial Equivalence Justification: The conclusion explicitly states: "The SudoPath device is equivalent in performances, technology, safety and efficacy to the legally marketed (unmodified) predicate device." This equivalence is established through the technical comparisons provided, not through a comparative clinical study.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study data, ground truth, expert involvement, or MRMC studies because this information is not present in the provided 510(k) summary.

Specifically, the document DOES NOT provide:

1. A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy, sensitivity, specificity, etc.) relevant to AI/ML or a diagnostic claim. The "performance" mentioned refers to the device's functionality and equivalence, not its diagnostic output accuracy.
2. Sample size used for the test set or data provenance because no clinical performance test set, in the sense of a diagnostic evaluation study, is described.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information on any Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size of human readers improving with AI assistance. This device is a measurement device, not an AI assistance tool for image interpretation.
6. Information on standalone algorithm 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 document primarily focuses on demonstrating that the changes made to the predicate device (EIS-GS) to create SudoPath are minor enough that new clinical performance data is not required, as it is fundamentally the same type of measurement device.

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