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The measurement of Galvanic Skin Response; Prescription Use

The ZYTO Hand Cradle is a Galvanic Skin Response Measurement Device. The device is designed, owned, manufactured, and distributed by ZYTO Technologies, Inc. The device consists of electrical circuit boards encased in a plastic/metal case. The device is non-invasive and comes in contact with the patient via conductive contacts (the equivalent of a stylus and hand-mass) incorporated into one piece, using the same functionality as the predicate device. The device connects to a computer to supply data to an operator.

The provided 510(k) summary for the ZYTO Hand Cradle describes performance testing conducted for substantial equivalence, but it does not provide specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for clinical performance evaluation (e.g., accuracy, sensitivity, specificity against a clinical gold standard).

Instead, the documentation focuses on bench testing for equivalency to a predicate device and electrical safety/EMC standards compliance.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance

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

• Bench Test: No specific number of "samples" (in terms of resistor values or repetitions) is stated, nor is the data provenance (e.g., country, retrospective/prospective) relevant for this type of test.
• Electrical Safety/EMC: Typically, one or a few units of the device are tested in a controlled laboratory environment. Data provenance is not applicable.

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

Not applicable. The "ground truth" for the bench test was the known values of the resistors and the performance of the predicate device. For electrical safety, the ground truth is defined by the technical standards. No human expert consensus was involved in establishing ground truth for these tests.

4. Adjudication method for the test set

Not applicable. There was no human judgment or adjudication process described for these engineering/bench tests.

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

No MRMC study was performed. The device is a measurement tool, not an AI-assisted diagnostic output for human readers.

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

The device itself is a standalone measurement instrument. The "Non-clinical Testing" section describes its standalone performance against a predicate and against electrical safety standards. There is no "algorithm" in the sense of a complex AI for diagnostic interpretation. It is a direct physiological measurement device.

7. The type of ground truth used

• Bench Test: The ground truth was the known resistance values of the resistors used for testing and the measured output of a legally marketed predicate device (K943101 - GLOBAL ENT. GALVANIC SKIN RESPONSE DEVICE).
• Electrical Safety/EMC: The ground truth was the requirements and limits defined by international standards EN60601-1-2 and EN55011 CLASS B PCC Part 15B.

8. The sample size for the training set

Not applicable. This device is a measurement device and does not describe any machine learning or AI components that would require a "training set."

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

Not applicable, as no training set was used.

Summary of the "Study" and Evidence Provided:

The "study" demonstrating the device meets acceptance criteria consists of:

1. Bench Testing for Performance Equivalence: Conducted by ZYTO Technologies, Inc. This involved comparing the ZYTO Hand Cradle's readings of various resistors against those obtained from a predicate device. The conclusion was that the responses were "substantially the same."
2. Independent Third-Party Electrical Safety and EMC Testing: Performed by SDP Engineering in December 2010. This validated the device's compliance with EN60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests) and EN55011 CLASS B PCC Part 15B (Limits and methods of measurement of radio disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment / FCC Part 15B, which governs electromagnetic compatibility). The device "met all testing requirements."

Conclusion:

The ZYTO Hand Cradle's 510(k) submission primarily relies on demonstrating substantial equivalence through engineering bench tests measuring its performance against a predicate device and adherence to electrical safety and electromagnetic compatibility standards. It explicitly focuses on the device's ability to measure Galvanic Skin Response, which is its stated intended use. The provided documentation does not detail a clinical study with patients, expert adjudication, or AI performance metrics, as these are not relevant for the type of device and the pathway used for its clearance.

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