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The Electro Antiperspirant, Electro Antiperspirant Sensitive, and the Electro Antiperspirant ELITE are tap water iontophoresis devices intended to treat hyperhidrosis (excessive sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences.

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I cannot provide the requested information. The provided text is a 510(k) clearance letter from the FDA for an iontophoresis device (Electro Antiperspirant), not an AI/ML medical device submission.

Therefore, the document does not contain:

• Acceptance criteria related to AI/ML device performance (like sensitivity, specificity, AUC).
• Details about a study proving the device meets AI/ML specific acceptance criteria (test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.).

The letter is a regulatory document confirming the device's substantial equivalence to predicates for its intended use (treating hyperhidrosis) and outlines general regulatory compliance requirements. It does not describe a clinical study in the context of AI/ML performance evaluation.

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