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This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.

HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis. The system consists of a control unit, power supply/safety wall adapter, and application accessories (treatment cover towel, treatment electrode, axillary sponge cushions). The control unit includes connection-jackets for accessories, control-buttons to choose the therapy-mode, a main display, and LED indicators. The device offers both DC and pulsed current output with adjustable pulse-width.

The provided text describes a 510(k) premarket notification for the Hidrex PSP1000 iontophoresis device, claiming substantial equivalence to two predicate devices: MD-1A (K964208) and Drionic (K831320). The document focuses on comparing the Hidrex PSP1000 with these predicates to establish that its differences do not raise new questions of safety or effectiveness.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, it compares the technical specifications and features of the Hidrex PSP1000 with those of its predicate devices to argue for substantial equivalence. The "performance" is described in terms of technical capabilities rather than clinical outcomes.

Here's a summary of the Hidrex PSP1000's technical performance metrics as reported:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document makes no mention of a "test set" for a clinical study to prove the device meets acceptance criteria related to efficacy or clinical outcomes. The studies mentioned are "non-clinical tests" to demonstrate electrical safety, software validation, performance, electromagnetic compatibility, and compliance with recognized standards (IEC 60601-1, IEC 60601-1-2). These are engineering and safety tests, not clinical performance studies with a sample size of patients.

The document mentions "Extensive trials showed that the efficiency of pulsed current could be increased dramatically" and "The additional benefit of the pulsed-current is demonstrated in several clinical trials." However, no details about these clinical trials (sample size, design, provenance) are provided within this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document discusses non-clinical engineering and safety tests, not clinical studies requiring expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set for performance or efficacy is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a medical device for treating hyperhidrosis, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The Hidrex PSP1000 is a physical medical device (iontophoresis device), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described (electrical safety, software validation, EMC), the "ground truth" would be established by compliance with international standards (IEC 60601-1, IEC 60601-1-2) and internal specifications. There is no mention of clinical ground truth (like pathology or outcomes data) for evaluation as this is a 510(k) submission focused on substantial equivalence rather than de novo clinical efficacy.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm.

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