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STOPWET is a Tap Water Iontophoresis apparatus. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands and feet.

STOPWET is designed for individuals suffering from hyperhidrosis (excessive sweating) of the hands and feet. It includes a pulse current generator and two pairs of containers for performing iontophoresis therapy specifically for hyperhidrosis. Users are required to place their hands or feet inside the containers, which contain dampened absorbent pads, and adjust the amplitude of the pulse current to a comfortable level. The circuit for the pulse current is limited to the distal end of the user's hands or feet, thereby minimizing the risk of cardiac discomfort. Additionally, users have the option to treat either the left or right hand using the single-limb treatment mode or treat both hands simultaneously with the dual-limb treatment mode. STOPWET can be used either in a clinical setting or at home. STOPWET is intended for users aged 13 years and above, including teenagers and adults. For teenagers aged 13 to 21 years, it is recommended to use this apparatus under adult supervision.

The provided FDA 510(k) clearance letter and summary for the STOPWET iontophoresis apparatus (SW01) does not contain information related to acceptance criteria and the study that proves the device meets specific performance thresholds in a clinical context for efficacy. Instead, the document focuses on bench testing for safety, electromagnetic compatibility, usability, software development, biocompatibility, and battery safety, alongside a substantial equivalence comparison to a predicate device.

The prompt specifically asks about acceptance criteria and a study that proves the device meets these criteria in terms of performance (which typically refers to clinical efficacy or accuracy for devices with a diagnostic or treatment outcome claim). The STOPWET device is an iontophoresis apparatus intended to treat hyperhidrosis. For such a device, performance would typically relate to its effectiveness in reducing sweating.

However, based on the provided text, here's an analysis of what information is available and what is missing per your request:

Information on Device Performance and Acceptance Criteria (Based on Provided Text)

The document describes bench testing to verify output parameters and ensure compliance with various standards related to safety and functionality. It does not present clinical performance data in terms of efficacy in treating hyperhidrosis or specific acceptance criteria for such efficacy.

The relevant section from the document states:

Performance: To demonstrate the output performance of STOPWET as substantially equivalent to the predicate, performance tests were conducted to verify the output parameters claimed by the specification.

This indicates that "performance" in this context refers to the device's ability to produce the specified electrical output (current, voltage, waveform, frequency, duty cycle), rather than its clinical effectiveness in treating hyperhidrosis. The acceptance criterion for this is simply "meets the specification."

Here's a breakdown of the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Output Parameters (Implied from "Performance" Bench Testing)

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