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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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The ActivaTek ActivaPatch Iontophoresis System 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 Iontophoresis System (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 Iontophoresis Patch consists of an electronic module, an LED indicator, an active electrode, and a return electrode. These elements are incorporated under an adhesive foam covering which adheres the device to the skin. Its dimensions are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).

The Iontophoresis Patch is designed to deliver a calibrated and fixed half dose of 40 mAmpminutes and a full dose of 80 mAmpminutes.

The ActivaPatch Iontophoresis System sequence of operation is signaled by its LED.

• a) The operator applies the ActivaPatch to the skin.
• b) The operator then pulls the tab located on the outer surface of the patch.
• c) In the Initial Skin Impedance Measurement Phase, the ActivaPatch measures voltage across the active and return electrodes to indicate the level of skin impedance. For high skin impedance, the LED flashes once every 4 seconds. This indicates that the skin impedance is too high for iontophoretic delivery. The treatment timer is not started. For moderate skin impedances, the LED flashes pulses four times every 30 seconds. The patch continues to monitor the skin impedance but does not turn on the treatment timer. When the skin impedance becomes optimal, the LED blinks once every 30 seconds. This indicates that the impedance is appropriate to start an iontophoretic treatment session and the ActivaPatch starts the treatment timer.
• d) In the First Half Dose Delivery Phase, the ActivaPatch LED continues to blink once every 30 seconds. This phase lasts 80 minutes and delivers an ionic dosage of 40 mA*minutes. At the end of the First Half Dose Delivery, the LED blinks short-long-short sequences every 30 seconds for 3 minutes. This signals to the user that the transition to the Second Half Dose Delivery Phase has begun.
• e) During the Second Half Dose Delivery Phase, the ActivaPatch LED blinks two pulses every 30 seconds. During this final phase, another 40 mA*minute dose is delivered. At the end of the delivery, the power in the device is automatically shut off and the LED does not blink.
• f) If at any time the skin impedance increases to high levels (e.g., the electrode falls off of the skin site) the ActivaPatch goes into the Skin Measurement Phase and the LED flashes pulses once every 4 seconds. The treatment timer is suspended and restarts when the skin impedance falls to optimal levels.

The provided text is a 510(k) summary for the ActivaTek ActivaPatch Iontophoresis System. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting a study with acceptance criteria and measured performance.

Therefore, many of the requested items (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in this type of regulatory submission. This document aims to demonstrate that the new device is as safe and effective as existing, legally marketed devices, rather than proving its "performance" against specific acceptance criteria in a detailed clinical study.

However, I can extract the acceptance criteria as implied by the device's specifications and the implicit "performance" is that it functions as described and is equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The "study that proves the device meets the acceptance criteria" is implicitly the technical and performance testing conducted by ActivaTek Inc. to demonstrate that the device functions according to its design specifications, allowing the FDA to determine substantial equivalence. Details of these specific tests are not provided in this 510(k) summary but would be part of the full 510(k) submission. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..." This indicates that the submitted documentation (including test reports, bench data, etc., which are not in this summary) was sufficient for their decision.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided in the 510(k) summary. Given the nature of an iontophoresis patch, testing would likely involve bench testing (electrical output, dosage accuracy, impedance monitoring), biocompatibility, and potentially limited human use studies for skin irritation or functionality, rather than large-scale clinical trials that would have clearly defined test sets and data provenance.

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 and not provided. The function of this device is largely objective (delivering a specific electrical dose) and does not involve subjective interpretation requiring expert ground truth in the way medical imaging AI might.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided.

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 patch, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a hardware medical device with some automated operational sequences. Its "standalone" performance would be its ability to deliver the specified dose and manage impedance as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a device like an iontophoresis patch, the "ground truth" for its performance would be derived from:

• Bench Test Measurements: Direct electrical measurements of current, voltage, time, and calculated dosage.
• Engineering Specifications: Adherence to defined parameters (e.g., 40 mAmpminutes, 80 mAmpminutes, 6V).
• Predicate Device Equivalence: Demonstrating that its performance characteristics are comparable to legally marketed predicate devices, which themselves have an established safety and efficacy profile.

8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that would require a "training set."

9. How the ground truth for the training set was established
Not applicable.

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