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The KimStim Auricular Electrode is designed as an accessory device intended to be used as an electrode. The device is sterilized for a single patient use and is reuseable. General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.

The KimStim Auricular Electrode is designed as an accessory device intended to be used as an electrode.

This document is a 510(k) clearance letter from the FDA for a device called "KimStim Auricular Electrode." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse organizatial equivalence of your device of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This means the device was cleared based on a determination of substantial equivalence to an existing predicate device, not on a new study demonstrating its efficacy or performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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