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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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The intended use of this tap-water iontophoresis device is to treat patients with hyperhidrosis (excessive sweating) of the palms, feet, armpits.

The medical Hidroxa SE30 is a tap water iontophoresis to treat focal hyperhidrosis to treat focal hyperhidrosis is considered state of the art and is one of the first line of treatments in many country's Clinical guidelines.

The Hidroxa SE30 iontophoresis device consists of two electrodes (Aluminium) which are connected to the main unit with one electrode cable each. The electrodes come in two different types. The small electrodes are used to treat hyperhidrosis of the armpits. The electrodes are covered by sponges pockets (cellulose), soaked in tap water and placed directly in the armain unit, one AC-adapter and two electrode cables. The large electrodes are used to treat hyperhidrosis of the palms and feet. Tap water is poured into two water bins and one large electrode is placed in each water bin. One towel (cotton) is placed over each of the electrodes to cover them. One hand/foot is then placed on each towel covered electrode. Treatment is performed by the main unit driving an electrical current through the intected treatment areas indirectly through the water in two water bins or via the electrodes in the alectrodes themselves will never be in direct contact with the skin, but instead cover the sponge pockets/towels during treatment. The main unit is powered from the wall mains using an AC adapter.

The treatment consists of two phases; 1. The initial phase consists of daily to every third day treatments (20 minutes) until desired results are seen. (Ordinary 12 treatments). When the desired results are achieved, switching to the maintenance schedule means treatments (ordinary 20 minutes) 1-3 three times per week to maintain the results.

This treatment can be done at home by the patient themselves or at a clinic with the aid of a medical professional.

The mechanism of action for tap water iontophoresis as a treatment of hyperhidrosis is not fully understood. Several hypotheses have been proposed in different medical papers. One of them is that the ions in the water form a mechanical blockage that prevents sweat from coming out of the sweat glands, resulting in less sweating. Another theory is that the treatment affects the nerve impulses connected to the sweat glands which leads to reduced activity in the glands and thus reduced or seized sweat production. Recent studies suggest that iontophoresis increases the threshold value in the nerve cells so that more stimuli is required for an action potential, a signal to the sweat gland, to arise. lontophoresis is generally considered to be a safe and effective treatment for hyperhidrosis in many cases but not a cure. Regular maintenance treatments are needed to maintain the achieved results.

The provided text is a 510(k) summary for the Hidroxa SE30 iontophoresis device. It describes the device, its intended use, and a comparison to a predicate device (Hidrex PSP1000). The document explicitly states: "N/A - no clinical tests submitted, referenced or relied on for this 510k application."

Therefore, based on the provided text, there is no study described that proves the device meets acceptance criteria related to its clinical effectiveness. The acceptance criteria and testing mentioned pertain to non-clinical aspects such as usability, firmware, longevity, materials, pH changes, and adherence to international standards.

Here's the breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed reported performance values for clinical efficacy. It lists categories of non-clinical tests and states that "all requirements were deemed fulfilled."

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

Not applicable, as no clinical studies were submitted or relied upon. For the non-clinical tests mentioned, specific sample sizes (e.g., number of units for longevity) and data provenance are not detailed in this 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, as no clinical studies were submitted or relied upon.

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

Not applicable, as no clinical studies were submitted or relied upon.

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. This device is an iontophoresis device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an iontophoresis device, not an algorithm.

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

Not applicable, as no clinical studies were submitted or relied upon. For the non-clinical tests, the "ground truth" would be the engineering specifications, safety standards, and user expectations.

8. The sample size for the training set

Not applicable, as no clinical studies or AI/algorithm training were involved.

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

Not applicable, as no clinical studies or AI/algorithm training were involved.

In summary: The provided 510(k) summary explicitly states that no clinical tests were submitted, referenced, or relied upon for this application. The substantial equivalence determination is based on the device's similarity to a predicate device (Hidrex PSP1000) in terms of operational principles, intended use, and basic functionality, along with non-clinical testing covering safety and performance aspects like usability, firmware, longevity, materials, and adherence to international standards.

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Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

The proposed device is indicated for the administration of soluble salts or other drugs into the body for medical purposes. The Iontophoresis Electrodes utilize adhesive electrodes have both anode and cathode electrodes that adhere to the skin. The electrodes may either be connected by leads (wires) to a separate controller Forming a current loop. The portion of the active electrode that contacts the skin also has a drug/solution reservoir. End users saturate the reservoir with the ionic solution to be delivered. The reservoir contacts the electrode and the drug/solution is delivered to the patient transdermally.

Five models (Small, Medium, Large, Butterfly and Return Electrode) are included in this series products, and they have the same intended purposes, working theories and specifications.

The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the Iontophoresis Electrodes (K232020).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison to a predicate device (Iontophoresis Drug Delivery Electrodes, K040495) to demonstrate substantial equivalence, rather than setting explicit numerical acceptance criteria for a new device's performance. The "acceptance criteria" are implied by the predicate device's specifications and the non-clinical test conclusions.

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 explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set or information on its provenance. The testing was non-clinical.

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, as no clinical study was conducted that would require expert ground truth. The evaluation focused on non-clinical performance and safety based on recognized standards.

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

Not applicable, as no clinical study was conducted.

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. This device is an Iontophoresis Electrode, which is a physical device for drug delivery, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm or software.

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

Not applicable, as no clinical study was conducted. The "ground truth" for the non-clinical tests was established by compliance with international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) and comparison to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable. This is a physical medical device, not a machine learning model.

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Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.

The Dermadry is a tap water Iontophoresis device intended to treat hyperhidrosis of the hands, feet and underarms. It achieves its action by producing a given low level direct current (DC) level between each of the two applicable members being treated (i.e. the two feet, or the two hands, or the two underarms) for a given amount of time. The current is controlled and transmitted by a controller between two electrodes in separate water basins into which each of the hands or feet are placed, or via two electrodes within water soaked spongeous pockets that are placed in each of the underarms. It is for home use by a single patient (single patient). It is for use by prescription under the direction of a physician or clinician, and is intended for adult patients.

The provided text is a 510(k) summary for the Dermadry Iontophoresis device. It details the device's substantial equivalence to a predicate device (Hidrex PSP1000) and describes its intended use, technology, and performance testing. However, it does not contain information related to specific acceptance criteria for clinical performance, or a study that evaluates device performance with human subjects or a specified ground truth, which would typically involve a multi-reader study or a standalone algorithm performance test.

The "Performance Data" section (Page 8) lists various engineering, electrical safety, biocompatibility, software verification/validation, and usability tests. These are largely for verifying the device's technical specifications and safety profile, not for proving clinical efficacy against specific performance metrics related to treating hyperhidrosis in a clinical trial setting.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and ground truth establishment are not present in this document because it is focused on establishing substantial equivalence based on technical and safety specifications rather than clinical performance outcomes against pre-defined metrics.

Here's a breakdown of what can and cannot be answered based on the provided document:

What can be extracted:

• Acceptance Criteria & Performance: The document doesn't define quantitative clinical acceptance criteria for its efficacy in treating hyperhidrosis (e.g., X% reduction in sweating). Instead, it argues for substantial equivalence based on the device's technical specifications and safety performance being comparable to or better than the predicate device. The "performance" discussed relates to engineering tests rather than clinical outcomes.

  • Table of Acceptance Criteria and Reported Device Performance: Not applicable in the context of clinical efficacy. The document focuses on technical specifications and safety as "performance."

    Criterion Type	Acceptance Criterion (Implicit/Explicit)	Reported Device Performance
    Intended Use	Same as predicate (Treat hyperhidrosis of hands, feet, underarms). Prescription Use, Home Use.	Same. "Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms... Prescription Use Only." (Page 4).
    Patient Population	Not raise new safety/effectiveness concerns compared to predicate (unspecified population).	"Difference: For adult patients." (Page 4). Argument: "This should not raise any new questions of safety or effectiveness since this is more specific and restrictive than in the predicate." (Page 6).
    Main Technology	Same as predicate (Tap water iontophoresis).	Same. "Tap water iontophoresis: Current applied between contralateral treated areas... via electrodes... in tap water... or via electrodes in sponges wetted with tap water." (Page 5).
    Treatment Current/Voltage/Time	Maximums should not raise new safety/effectiveness concerns. Current levels should be effective.	Differences. Dermadry: Hands: 1-15mA max, 48V max, 20 min. Feet: 1-25mA max, 55V max, 20 min. Armpits: 1-8mA max, 30V max, 15 min. (Page 5). Argument: "current levels in the Dermadry are of the same order as those typically used in Iontophoresis device for hyperhidrosis (around 10 - 25 mA). Therefore, these differences do not raise any new questions of safety or effectiveness." (Page 6). Max energy output 1650J over 20 min vs 1890J over 15 min for predicate (Page 7).
    Current/Voltage Control	Not raise new safety/effectiveness concerns.	Difference: Dermadry maintains desired current by adjusting voltage (predicate maintains voltage by adjusting current). Argument: "these differences do not raise any new questions of safety or effectiveness." (Page 6).
    Max Current Density	Not raise new risk concerns, adequately effective.	Differences. Dermadry values lower (e.g., Hands: 0.10 mA/in2 vs. 0.28 mA/in2 for predicate). Argument: "These should therefore not present any new risk concerns... while still providing adequately effective current levels." (Page 7).
    Output Pulsed Current	Not raise new risk concerns, within predicate's available settings or justifiable variation.	Differences. Dermadry fixed at 90% pulse width (predicate user selectable 50-100%). Argument: "Given that the Dermadry setting is within that of available settings in the predicate and that this characteristic is more related to patient comfort, it does not present any new risk concerns." (Page 7).
    Polarity Reversal	Not raise new risk concerns, ideally improve safety.	Differences. Dermadry automatic reversal (predicate manual reversal). Argument: "This further ensures that the polarity will be reversed to help minimize pH changes and related effects. Therefore, this does not present any new risk concerns." (Page 7).
    Hardware Output Limits	Not raise new risk concerns, ideally improved safety.	Differences. Dermadry 60V / 30mA (predicate 60V / 35mA). Argument: "Given the slightly improved safety level, this does not present any new risk concerns." (Page 7).
    Electrical Safety	Per IEC 60601-1 and IEC 60601-1-2.	Tested and Compliant. (Page 8).
    Biocompatibility	Per ISO 10993-1 and related FDA Guidance.	Evaluated and Compliant. (Page 8).
    Software Verification/Validation	Per IEC 62304 and FDA Guidance.	Tested and Compliant. (Page 8).
    Usability Performance	Per IEC 60601-1-6 & IEC 62366-1.	Tested and Compliant. (Page 8).
    Home Use Safety	Per IEC 60601-1-11.	Tested and Compliant. (Page 8).

• Sample Size for test set and data provenance: Not mentioned. The document focuses on demonstrating substantial equivalence through technical comparative analysis and engineering/safety tests, not clinical performance studies with a test set of patient data.

• Number of experts and qualifications for ground truth: Not applicable. No clinical expert review or consensus process for establishing ground truth data is described, as no clinical performance study is detailed.

• Adjudication method: Not applicable. No clinical study with expert review.

• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study would compare human readers' performance with and without an AI assistance, which is not relevant for this type of device (an iontophoresis device, not an imaging AI diagnostic aid). There is no mention of such a study.

• Standalone (algorithm-only) performance: Not applicable. This is a physical medical device for treatment, not an algorithm for diagnosis or image analysis.

• Type of ground truth used: Not applicable. No clinical ground truth (e.g., pathology, outcomes data) is used to evaluate device performance in a clinical study context. The "ground truth" here is compliance with engineering standards and comparison to a predicate device's technical specifications.

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

• How the ground truth for the training set was established: Not applicable, as there's no training set for this device.

In summary:

This FDA 510(k) clearance document is for a medical device (iontophoresis device) that treats hyperhidrosis. The "acceptance criteria" and "study" described in the document are primarily related to proving technical and safety equivalence to a legally marketed predicate device, rather than a clinical performance study with human subjects and a ground truth for efficacy. Therefore, detailed information about clinical study design parameters such as sample size, expert ground truth establishment, MRMC studies, or training sets for AI algorithms is not present.

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Tap water iontophoresis device 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.

The Saalio® unit is a therapeutic device for the treatment of primary focal hyperhidrosis, i.e. excessive sweating of defined body parts. The control device is powered by an external power supply and connected to two electrodes by means of two single cables. The electrodes are brought in contact with the body parts to be treated via a conductive water passage, thus closing the electric circuit. The control device conducts direct current or pulsed direct current) through the body parts.

Depending on the body part to be treated, different electrodes are used. For the treatment of hands and feet, two generous sized silicone electrodes are placed into two travs filled with tap water. The electrodes are covered with foam inserts so as to prevent the body parts to be treated making direct contact with the electrodes. For the treatment of armpits, two smaller silicone electrodes are inserted into sponge pads which have been saturated with tap water. These are then tucked under the armpits for the duration of the treatment. It must be insured that the sponge material is always sufficiently saturated.

The provided document is a 510(k) premarket notification for the "Saalio®" iontophoresis device. It focuses on demonstrating substantial equivalence to a predicate device, the "HIDREX PSP1000".

However, the document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-driven performance claim. Instead, it details the device's technical specifications, mechanical features, safety testing (electrical safety, EMC, home healthcare environment safety, biocompatibility), and quality assurance.

The "Performance data" section in the document refers to the technical specifications of the device's current output, signal type, and controls, not the clinical performance in treating hyperhidrosis or any acceptance criteria for such a clinical outcome.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) because this type of study was not performed or documented in this 510(k) for this specific device. This device is an iontophoresis device used for treatment, not a diagnostic or AI-driven system that would typically have the performance studies and acceptance criteria you're asking about.

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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.

Not Found

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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IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

IontoDC is a bench-top, battery powered, microcontrollercontrolled iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

This 510(k) premarket notification describes the IontoDC, an iontophoresis device. The review of the provided document indicates that the submission focuses on demonstrating substantial equivalence based on technological characteristics and performance testing against predicate devices, rather than a clinical study evaluating the device's efficacy in treating a specific condition or detecting a disease. Therefore, many of the requested items related to clinical studies, such as sample sizes for test and training sets, expert qualifications, and comparative effectiveness studies, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IontoDC device are implicitly the electrical output parameters and safety standards of the predicate devices and relevant IEC standards. The document outlines a comparison of the IontoDC's parameters with two predicate devices: Dynatron® ibox (primary) and ActivaDose II (reference).

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

• Not Applicable. The submission relies on bench testing and compliance with international standards (IEC 60601-1, IEC 60601-1-2) for electrical output parameters and EMC, and software verification and validation. There is no clinical test set mentioned.

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. There was no clinical test set requiring expert consensus for ground truth. The "ground truth" for this device's performance is compliance with established electrical and safety standards, as measured by engineering tests.

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

• Not Applicable. No clinical test set.

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. This is a hardware device (iontophoresis device), not an AI/imaging diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This device is not an algorithm. Bench testing evaluated the device's performance in isolation.

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

• The "ground truth" for demonstrating substantial equivalence for this device is based on:
  • Compliance with recognized electrical safety and EMC standards: IEC 60601-1 (medical electrical equipment general requirements for basic safety and essential performance) and IEC 60601-1-2 (medical electrical equipment electromagnetic compatibility).
  • Bench testing measurements: Direct comparison of the electrical output parameters of the IontoDC device against those of the predicate devices.
  • Software verification and validation: As per FDA guidance for a "Moderate" level of concern software.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/imaging device. The device's design and manufacturing processes are likely informed by engineering principles and iterations, but not a data-driven training set in the typical AI sense.

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

• Not Applicable. See point 8.

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The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.

The Acclarent Iontophoresis System with Earset (IPSES) is a single-use device that employs electric current to transport drug solution, salts, or ions into the ear, including the tympanic membrane. The TULA Iontophoresis System consists of three components, namely an Iontophoresis Control Unit, Iontophoresis Earsets and a Return Electrode Patch. Accessories to the IPSES include a Syringe and Earset Sizers. All components of the IPSES are provided non-sterile and no sterilization is required.

This document is a 510(k) summary for the Acclarent TULA® Iontophoresis System with Earset. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of clinical performance metrics. Therefore, many of the requested details regarding clinical study design, sample sizes, expert involvement, and ground truth are not present in this type of regulatory submission.

However, I can extract the available information regarding performance data and acceptance criteria based on bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily describes bench verification testing performed to demonstrate substantial equivalence to a predicate device, focusing on design inputs and intended performance characteristics. Specific quantitative acceptance criteria are not explicitly listed in a table format, but the performance data indicates that the device met these criteria.

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

The document describes bench verification testing, not a clinical trial. Therefore, information regarding a "test set" in the context of patient data, sample sizes for such a set, or data provenance (country of origin, retrospective/prospective) is not provided and is not applicable to the reported testing. The tests would involve physical device units rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As the provided text focuses on bench testing and substantial equivalence, there is no mention of "experts" being used to establish "ground truth" in a clinical sense. The testing performed would have been evaluated against engineering specifications and industry standards by technical personnel.

4. Adjudication Method

Not applicable, as this refers to adjudication of clinical data, which is not described.

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

Not applicable. The document describes a 510(k) submission for a medical device (iontophoresis system) based on substantial equivalence. This type of submission typically involves bench testing and comparison to a predicate device, not MRMC studies comparing human readers' performance with and without AI assistance.

6. Standalone Performance Study

The document describes bench verification testing of the device's functional and safety characteristics. This can be considered a form of standalone performance evaluation for the device itself (e.g., electrical safety, mechanical integrity). However, it is not a "standalone algorithm performance" in the context of an AI/ML device, as this is a physical medical device. The "Performance Data" section lists various tests performed on the device to ensure it meets design inputs and standards.

7. Type of Ground Truth Used

For the bench testing described, the "ground truth" would be established by:

• Engineering specifications and design inputs: The device's performance was compared against predetermined technical requirements.
• Industry standards: Compliance with standards like IEC 60601-1 and IEC 60601-1-2 served as the "ground truth" for electrical safety.
• Predicate device characteristics: Performance was also implicitly compared to the characteristics of the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This document does not describe an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model described in this document.

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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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The Activatek ActivaPatch ET Intophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The Activatek ActivaPatch ET Iontophoresis Patch consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol.

The ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).

Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.

The provided text describes a 510(k) summary for the ActivaPatch ET Iontophoresis Patch. While it outlines the device's specifications and its comparison to predicate devices, it does not contain information regarding a study that proves the device meets specific performance acceptance criteria based on clinical outcomes or a comparative effectiveness study with human readers.

The "Performance Data" section explicitly states: "There are no applicable Guidance Documents specifically associated with this type of medical device." This indicates that the regulatory submission primarily relies on substantial equivalence to predicate devices rather than new performance studies demonstrating achievement of specific metrics.

Therefore, I cannot populate the requested tables and information fields related to acceptance criteria and performance study details from the provided text.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Reported Device Performance: This device is undergoing a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily meeting a set of pre-defined performance acceptance criteria from new clinical trials. The text only compares its specifications (dosage, voltage) to predicate devices, not clinical performance metrics against specific targets.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document does not describe any clinical study that was conducted to assess the performance of the ActivaPatch ET Iontophoresis Patch against a set of acceptance criteria. The information provided is primarily about the device's technical specifications and its similarity to existing devices.

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence, not a report of a performance study with defined acceptance criteria and results.

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