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The Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts and other drugs into the body for medical purposes as an alternative to hypodermic injections when it is advisable to avoid the pain that may accompany needle insertion and drug injection; when it is advisable to minimize the infiltration of carrier fluids; to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using Iontocaine™, brand of Lidocaine HCI 2% and Epinephrine 1:100,000.

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.

The Phoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.

The provided text describes a 510(k) summary for the IOMED Phoresor® II, Model PM900 iontophoresis device, which is seeking substantial equivalence to the predicate device, the IOMED Phoresor® II, Model PM800. The focus is on the functional equivalence of the new device to the predicate.

Here's an analysis of the acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable form often seen for AI/ML devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document mentions "testing data" and "non-clinical testing" but does not provide details on the number of units tested or and cases/scenarios/patients involved in these tests.
• Data Provenance: Not specified. It's likely that the testing was performed internally by the manufacturer (IOMED, Inc. in Salt Lake City, UT) as part of their design verification and validation process, which is typical for device modifications aiming for substantial equivalence. The data is retrospective in the sense that it's based on internal testing and comparison to an existing device, rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Given that this is a non-clinical performance summary for an iontophoresis device (which focuses on electrical and functional outputs), the "ground truth" would likely be established by engineering specifications, calibration standards, and direct measurement against the predicate device's known performance, rather than expert clinical judgment in the way it would be for an AI diagnostic tool.

4. Adjudication method for the test set:

Not applicable or not specified. Given the nature of the device (electrical output and control), the "adjudication method" would involve comparing measured outputs against expected values or the predicate device's outputs, which is a direct technical comparison rather than a consensus-based human adjudication process.

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/ML diagnostic or assistive tool where human readers/interpreters would be involved.

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

Not applicable in the context of an "algorithm only" performance as understood for AI/ML. The device itself is a standalone medical device that performs a function. The "performance" described is the device's functional output, which is assessed inherently in a "standalone" manner (i.e., the device's outputs are measured independently). However, this is not an AI algorithm.

7. The type of ground truth used:

The ground truth, in this context, is the functional output and technical characteristics of the predicate device (IOMED Phoresor® II, Model PM800) and established engineering specifications/standards. The PM900's output and characteristics were compared against these known values to determine functional identity and substantial equivalence.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set." The software redesign mentioned is for control functions and Good Manufacturing Practices adherence, not for learning from data to perform a task.

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

Not applicable, as there is no training set for this type of device.

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The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.

ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.

I am sorry, but the provided text from the K974855 submission does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary and the FDA's response letter for the Phoresor® II, Model PM900 iontophoresis device. It focuses on:

• Device Description and Intended Use: Explaining what the device is and its purpose (administration of soluble salts or other drugs into the body for medical purposes, specifically local dermal anesthesia using Iontocaine™).
• Predicate Device: Identifying the previous model (Phoresor® II, Model PM800) for substantial equivalence comparison.
• Regulatory Classification: Discussing the classification of iontophoresis devices (Class II or Class III) and the conditions under which the PM900 is considered substantially equivalent.
• FDA's Decision: Confirming the device's substantial equivalence to devices marketed prior to May 28, 1976, provided it complies with regulations, particularly regarding drug labeling and manufacturing practices. The approval specifically applies to the use with Iontocaine™.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or the nature of any study dataset.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and ground truth establishment as might be seen for novel high-risk medical devices or AI-powered diagnostics. In this case, the updated device (PM900) is being compared to its predecessor (PM800), and the focus is on its intended use for drug delivery, not diagnostic performance.

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