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SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands.

The SudoC 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.

The SudoC 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 2 tactile electrodes placed on the sole of each foot.
• Software installed on a computer. ●

As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

The provided text is a 510(k) Premarket Notification for a device named SudoC. This document primarily focuses on demonstrating that the SudoC device is substantially equivalent to a previously cleared predicate device (SudoPath K131568) and does not contain detailed information about specific acceptance criteria, study designs, or reported device performance for the SudoC as an independent, de novo submission would.

Therefore, many of the requested details cannot be extracted directly from this document. However, I can provide the information that is present and explain why other information is not available.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or reported performance values for the SudoC. The core of this submission is to demonstrate substantial equivalence to a predicate device, meaning it asserts that the modifications to SudoC do not change its performance.

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

This information is not provided. The document states that the modifications to the proposed device "do not change the performance of the device" as shown with:

• New risk management
• Software verification (SRS/SDS/STD/STR)
• Summary of Design Control Activities and Declaration of Design control conformity.
• Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode.
• The removal of the hand electrodes does not affect the performance of the galvanic skin response measurement.

The crucial point is the "Comparison of the conductance values" which suggests some testing was done, but details like sample size, provenance, or whether it was a "test set" in the context of a clinical study are absent.

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)

This information is not provided. The SudoC is a galvanic skin response measurement device, which measures physiological responses. "Ground truth" in this context would likely refer to the accuracy of the measurements themselves or their correlation with a specific physiological state, which is not detailed in this type of submission for substantial equivalence.

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

This information is not provided.

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

This information is not provided. The device (SudoC) is described as a measurement device that provides values, and "It is the physician's responsibility to make proper judgments based on these numbers." This indicates it's a diagnostic aid, not an AI-assisted detection or interpretation system that would typically involve human reader performance studies.

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

The SudoC is a measurement device. It provides raw "values." The "algorithm" here would be the processing of the galvanic skin response to produce those values. The document asserts that the fundamental scientific technology and the range of conductance measurements (1 to 120 micro Siemens) are the same as the predicate. While software verification was done, a standalone performance study with specific metrics is not detailed as per the typical requirements for a new, complex algorithm or AI.

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

This information is not explicitly stated. For a galvanic skin response device, the ground truth would likely be the accurate measurement of skin conductance. The document states "Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode," suggesting that the accuracy of the conductance measurement itself with the new electrodes was assessed against the prior electrode type.

8. The sample size for the training set

This information is not provided. Since this is a 510(k) for a measurement device and not an AI/ML algorithm requiring extensive training data, such details are typically not included unless the specific modifications involved significant new algorithmic development or a new intended use. The software changes primarily relate to "New design and change in time and sequence of measurement."

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

This information is not provided, for the same reasons as point 8.

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