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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)

Note: These are implied acceptance criteria based on the device's stated specifications and the general nature of "performance tests were conducted to verify the output parameters claimed by the specification." The document does not provide specific numerical outcomes for these bench tests, only that they "were conducted to verify the output parameters."

For other areas (Electrical Safety, EMC, Home Use Safety, Usability, Software, Biocompatibility, Battery Safety):
The acceptance criterion for these is "Meets the requirement of [Standard Name]". The reported performance is simply that the device "Meets the requirement" for each listed standard (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62366-1, IEC 62304, ISO 10993-1, IEC 62133). No specific numerical results are provided for these tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable/Not provided. The provided document details bench testing, which typically does not involve human subjects or a "test set" in the clinical performance sense. The "performance tests" relate to verifying electrical output, not clinical efficacy. No data is mentioned from clinical trials.
• Data Provenance: Not applicable. As the "test set" refers to electrical and safety bench tests, there's no "country of origin of the data" or "retrospective/prospective" aspect in the clinical sense. The tests were performed to demonstrate compliance with international standards by Taiwan Medical Electronics Co., Ltd.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. Since the testing described is bench testing for electrical output, safety, and compliance with standards, there is no "ground truth" derived from expert review in the sense of clinical image interpretation or diagnosis. The ground truth for electrical performance would be the calibrated measuring equipment.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical "test set" with human subject data requiring expert interpretation or consensus is described, no adjudication method was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The device (STOPWET) is an iontophoresis apparatus for treating hyperhidrosis, not an AI-assisted diagnostic tool where human readers would interpret results. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device type.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable/Not relevant. This device is a treatment apparatus, not an algorithm. Its "performance" refers to its electrical output properties and safety, which are intrinsically standalone characteristics of the device itself. There is no AI algorithm component.

7. The Type of Ground Truth Used

• For electrical/physical performance: The "ground truth" is adherence to predefined engineering specifications and compliance with international safety and performance standards (e.g., IEC 60601-1, IEC 62366-1). This is established through highly precise and calibrated measurement equipment.
• For clinical efficacy: Not addressed in the provided document. The document states that the effectiveness has "been proven to be effective" (referring to the efficacy of the current settings, which are lower than the predicate but still within effective ranges), but it does not provide study data or the ground truth method (e.g., patient reported outcomes, sweat production measurements) used to support this claim in a clinical trial setting. The substantial equivalence argument relies on the predicate's established efficacy.

8. The Sample Size for the Training Set

• Not applicable. This device is hardware for physical therapy/treatment. There is no machine learning "training set" involved in its development, as it does not rely on learned algorithms for its primary function.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See point 8).

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