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to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises.

Cryotron is fabricated by joining two hollow metal or plastic tubes together into a hollow metal tip which is shaped to fit over the maxillary nerve section or other area selected for cold therapy. Ice water driven by a small pump enters the smaller ube and exits the large tube, chilling the metal which is covered by a disposable plastic sheath. The product will be sold non-sterile; prepackaged, presterilized plastic sleeves will be provided with the Cryotron.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and materials.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details based on the provided text. The document is for a medical device (Cryotron™ Cold Probe) that circulates ice water for cold therapy, and the summary's purpose is to argue for its substantial equivalence to other legally marketed devices, thus avoiding the need for a full premarket approval.

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