(133 days)
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).
| Feature / Characteristic | Proposed Device (SUDOSCAN K141872) | Predicate Device (SUDOSCAN K100233) |
|---|---|---|
| Indication for Use | To aid in the assessment of sudomotor function in the general adult population. | Measurement of galvanic skin responses. |
| Operating Characteristics | Measures difference in skin conductance; provides feedback to physicians, not to diagnose; skin contact pads measure skin conductance. | Measures difference in skin conductance; provides feedback to physicians, not to diagnose; skin contact pads measure skin conductance. |
| Electrode Placement | Hands, Feet | Hands, Feet, Forehead |
| Skin Conductance Measurement Range | 10-100,000 nS/cm² | 10-100,000 nS/cm² |
| Skin Conductance Resolution | 1 nS/cm² | 1 nS/cm² |
| Acquisition Duration (total) | 120 seconds | 120 seconds |
| Electrical Output to the skin | 4 V max | 4 V max |
| Electrical Output Frequency | Continuous | Continuous |
| Electrical Output Unit Duration | 1 second | 1 second |
| Power Density (at electrode) | 0.01 μA/mm² | 0.01 μA/mm² |
| User Display | VGA Color LCD 1024*768 | VGA Color LCD 1024*768 |
| User Control | Touch screen | Touch screen |
| Audible Indicators | Internal Speaker and Optional Headphone | Internal Speaker and Optional Headphone |
| Interface | (USB) Internal | (USB) Internal |
| Power Source | 5 V provided by USB | 5 V provided by USB |
| Electrode Surface Area (Hand) | 212 cm² | 212 cm² |
| Electrode Surface Area (Foot) | 269 cm² | 269 cm² |
| Electrode Surface Area (Head) | N/A | 7 cm² |
| Electrode Patient Contact Material (Hand & Feet) | Stainless Steel (AISI 304) | Stainless Steel (AISI 304) |
| Electrode Patient Contact Material (Head) | N/A | Nickel Silver Alloy |
| Standards Met | IEC60601 -1 -1, EN60601-1-2, ANSI/AAMI PC69 | IEC60601 -1 -1, EN60601-1-2 |
| Test Report (STC measurements) | Hand: Average of 6 STC measurements; Foot: Average of 6 STC measurements (Total 12) | Hand: Average of 6 STC measurements; Foot: Average of 6 STC measurements; Head: Average of 6 STC measurements (Total 18) |
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.
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.