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XinBo Electrodes (Model: Neck Therapy Pro - II; Neck Therapy Pro - II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the back of the neck, upper back and shoulder surface areas with which they are in contact.

The electrodes can be use together with any legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. For the silver coated Nylon yarn electrodes, they can be used dry or wet when in contact with the skin. The entire surface of each electrodes is very conductive having a resistance of less than 7 ohms per inch; For the model "Neck Therapy Pro - III", conductive silicone rubber having a resistance of less than 7 ohms per inch, these low resistance provides low current density with uniform current distribution.

The provided text describes XinBo Electrodes, a device classified as a cutaneous electrode (product code GXY, regulation number 882.1320), and its 510(k) submission for demonstrating substantial equivalence to legally marketed predicate devices.

However, the document does not contain information about the acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML medical device where performance metrics like accuracy, sensitivity, or specificity would typically be evaluated against a ground truth established by experts.

The document details the following about the XinBo Electrodes:

• Device Type: Cutaneous electrodes for use with TENS stimulating devices.
• Intended Use: Deliver stimulation signals to the back of the neck, upper back, and shoulder surface areas.
• Testing Conducted:
  • Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards.
  • Electrode wire compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) evaluation.
  • Performance test (hot spots verification test) according to manufacturer self-requirements.
  • Usability study according to IEC 60601-1-6, IEC 62366, and "FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices."

The document focuses on the physical and electrical safety and performance of the electrodes themselves, rather than the performance of an AI/ML algorithm or a diagnostic tool. Therefore, the requested information about acceptance criteria for AI/ML performance, study design with test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable or present in this document.

The document confirms that the device is "Substantial Equivalent" to predicate devices based on technological characteristics, features, specifications, materials, and intended use, and that the conducted bench testing and usability studies found no new safety or effectiveness issues.

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