Iontophoretic drug delivery devices are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or 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 on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.

The IOMED, Inc. Champion integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, oneapplication use and can only be used with IOMED's Champion dose controller. The Champion dose controller provides control of the current and therefore dosage delivered.

The Champion dose controller is a small, battery-powered, microprocessor-controlled iontophoretic device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

The provided document, K063465, is a 510(k) premarket notification for the "Champion Iontophoresis Drug Delivery System." This submission focuses on establishing substantial equivalence to predicate devices and demonstrating general safety and effectiveness through in vitro drug delivery and biocompatibility testing. It is not a study describing acceptance criteria and device performance in the context of a typical algorithm or diagnostic device evaluation.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to clinical trials, algorithm performance metrics, or expert adjudication which are not relevant to the approval of this physical drug delivery device.

However, I can extract information related to the in vitro testing and safety assessments that were presented as part of the submission to demonstrate the device's functionality and safety.

Here's a breakdown of the available and unavailable information based on your request:

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

Note: The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it describes tests performed and their outcomes which serve to demonstrate the device's functionality and safety in comparison to predicate devices and established standards.

Specifics: In vitro testing used dexamethasone sodium phosphate (negative) and lidocaine hydrochloride (positive) as model drugs. Quantified by radioassay (3H-dexamethasone and 14C-lidocaine) in skin and receptor solution. |
| Biocompatibility/Irritation: Materials used in the patch should be biocompatible and cause acceptable levels of dermal irritation, consistent with predicate devices and safety standards. (Implicit, based on predicate device history and industry standards for medical devices). The predicate device (RH-801/GS) showed acceptable irritation levels. | Acceptable Biocompatibility/Irritation: "The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950."

Predicate Device Performance (RH-801/GS):

• Rated as a mild irritant (0.5) during lidocaine administration (

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Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodernic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 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 on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The IOMED, Inc. MW-1000 iontophoresis system consists of an active delivery electrode and a return electrode. The electrodes are designed for a single-patient, oncapplication use and should be used with IOMED's approved iontophoretic dose controller. The active delivery electrode is attached to a handle which is used to guide the device over the area to be treated. The handle is designed to be reused.

The IOMED, Inc. MW-1000 iontophoresis system is designed to attach to IOMED's approved Phoresor . These devices provide control of the current and therefore dosage delivered.

Here's an analysis of the provided text regarding the IOMED MW-1000 Iontophoretic Drug Delivery Electrode, structured to address your specific questions about acceptance criteria and supporting studies:

This document primarily describes an Iontophoresis device and its substantial equivalence to predicate devices, focusing on regulatory approval for marketing rather than detailed performance study results that would typically include specific quantitative acceptance criteria for a new AI/medical device. The "acceptance criteria" here are largely related to safety and biocompatibility and demonstration of drug delivery capability being equivalent or superior to predicate devices, rather than a quantifiable performance metric like sensitivity or specificity.

Acceptance Criteria and Reported Device Performance

Detailed breakdown of study information based on your questions:

1. A table of acceptance criteria and the reported device performance:
Provided above. The acceptance criteria are largely implied by the context of a 510(k) submission, focusing on safety, biocompatibility, and functional equivalence to existing devices.

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

• Drug Delivery Study:
  • Test Set: "freshly excised hairless mouse skin." The number of mice or skin samples is not specified.
  • Data Provenance: Not explicitly stated, but an in-vitro study.
• Safety and Biocompatibility (Primary Dermal Irritation) Study:
  • Test Set: "rabbits." The number of rabbits used is not specified.
  • Data Provenance: Not explicitly stated, but carried out "in accordance with FDA regulations for Good Laboratory Practices." This suggests a prospective study design.

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):

• Drug Delivery Study: The "ground truth" here is the actual amount of drug delivered and quantified. This would have been established through a laboratory process (radioassay) by trained lab personnel, not necessarily "experts" in the clinical sense (like radiologists). No specific number or qualifications are given for these personnel in the document.
• Safety and Biocompatibility Study: The "ground truth" (irritation scores) would have been established by trained personnel, likely toxicologists or veterinarians, following standard protocols. The document states "Using standard Primary Dermal Irritation Index scores," implying a standardized evaluation, but does not specify the number or qualifications of the evaluators.

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

• Not Applicable / Not Specified: For in-vitro drug delivery and animal irritation studies, the concept of "adjudication" as typically applied to human clinical image or diagnostic interpretation (e.g., 2+1 expert consensus for ground truth) does not apply. Results are typically based on quantitative measurements and standardized scoring protocols.

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:

• No: This device is an iontophoresis electrode, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant and was not performed.

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

• Not Applicable: This is a hardware device for drug delivery, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.

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

• Drug Delivery: Quantitative measurement of radiolabeled drugs in skin and receptor solutions (radioassay).
• Biocompatibility: Standardized Primary Dermal Irritation Index scores based on visual assessment of skin reactions in rabbits.

8. The sample size for the training set:

• Not Applicable: This is a hardware device, not a machine learning algorithm that requires a "training set." The study data presented is for validation/testing of the device's physical properties and function.

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

• Not Applicable: As there is no training set, this question is not applicable.

Summary Takeaway:

The provided document is a 510(k) summary for a medical device (iontophoresis electrode). It focuses on demonstrating substantial equivalence to predicate devices through in-vitro and animal studies rather than presenting quantifiable clinical performance metrics typically associated with AI or diagnostic devices. The "acceptance criteria" revolve around regulatory compliance, demonstrable drug delivery function, and acceptable safety/biocompatibility profiles as measured by established laboratory methods.

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Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device 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 on the charge and molecular wcight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The IOMED, Inc. RH-950 iontophoresis electrode patch consists of an active delivery electrode and a passive return electrode. These electrodes are designed for a singlepatient, one-application use.

This electrode is powered by an on-board 1.5-volt button-cell battery. The maximum allowable electrical current is controlled by means of a fixed in-series resistor included in the device, while the treatment duration is pre-defined and controlled by a printed conductive ink limit switch.

The RH-950 iontophoresis electrode consists of dry, monolithic, impregnated polyester nonwoven fabric drug and clectrolyte containment pads designed to be hydrated with aqueous solutions of the drug and electrolyte immediately prior to use. It features a Silver-based metallic conductive current distribution component and a medical-grade pressure sensitive adhesive tape border for skin attachment. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

The provided text describes the IOMED, Inc. RH-950 iontophoresis electrode. However, it does not contain specific acceptance criteria, performance metrics, or study details in the format requested. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will extract what is available and note what is missing.

Acceptance Criteria and Study Details for IOMED, Inc. RH-950 Iontophoresis Electrode

The provided document, a 510(k) summary for the IOMED, Inc. RH-950 iontophoresis electrode, primarily focuses on demonstrating substantial equivalence to predicate devices (IOMED RH-900 and Birch Point IontoPatch). It describes the device, its intended use, and comparative testing for drug delivery and biocompatibility. However, it does not define specific numerical acceptance criteria for performance or explicitly detail a "study that proves the device meets the acceptance criteria" in a typical clinical trial or rigorous performance study format. Instead, it presents comparative data against a predicate device.

Below is an attempt to structure the available information according to your request, with significant caveats about missing data.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" for performance. The "performance" is largely demonstrated through comparability to a predicate device.

• 0.1 (negligible) when operated from negative polarity.
• 0.3 (negligible) when operated from positive polarity.
  These scores are "comparable to the IOMED, Inc. RH-900 electrode" (which is self-referential but implies meeting the negligible category). Scores for the Birch Point predicate were not available for comparison. |
  | Biocompatibility - Cytotoxicity | Meeting USP and ISO 10993-10 requirements, indicating 'mild' reactivity (e.g., Grade 2 on a 0-4 scale). | RH-950 (materials identical to RH-900): Not directly tested, but the RH-900 showed a cytotoxic grade of 2 (on a 0 to 4 scale), indicating 'mild' reactivity. This "meets USP and ISO 10993-10 requirements and shows that all the materials used in the RH-950 are safe to come in limited contact with intact patient skin." |

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

• Drug Delivery Test Set: Not explicitly stated. The study involved "hairless mouse skin in vitro." The number of samples (e.g., number of skin pieces, number of repetitions) is not provided.
• Biocompatibility - Primary Dermal Irritation Test Set: "Rabbits." The specific number of animals is not provided.
• Biocompatibility - Cytotoxicity Test Set: Not explicitly stated, as direct testing was not done on RH-950. The RH-900 results are referenced. Specific sample size for RH-900 cytotoxicity is not provided.
• Data Provenance: The drug delivery study was in vitro. The dermal irritation study involved "rabbits." No country of origin is specified for these studies, but the regulatory submission is to the US FDA. The studies appear to be prospective in nature, conducted for the purpose of demonstrating equivalence.

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

• Not applicable in the context of the provided information. "Ground truth" in this document refers to analytical measurements (drug transport) and standardized biological response assessments (irritation, cytotoxicity) rather than expert interpretation of images or clinical outcomes. The studies were conducted according to established scientific protocols (e.g., Petelenz et al., J Controlled Release 20 (1992), 55-56 for drug delivery; ISO 10993-10:2002 and GLP for biocompatibility).

4. Adjudication Method for the Test Set

• Not applicable. This is not a study relying on subjective adjudication of results. Measurements and observations were made according to scientific protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The RH-950 is an iontophoresis electrode, and its evaluation relies on drug delivery kinetics and biocompatibility, not reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This device is a passive electrode, not an algorithm. Its performance is evaluated intrinsically through its physical and chemical properties and interaction with biological systems, not as an "algorithm only" component.

7. The Type of Ground Truth Used

• Drug Delivery: Quantitative measurements of drug transport (e.g., amount of drug delivered across the skin) in an in vitro model. This is an objective, measured outcome.
• Biocompatibility (Dermal Irritation): Standardized scoring of observed biological reactions in animal models (rabbits) according to ISO 10993-10:2002 guidelines. These scores are objective based on a predefined scale.
• Biocompatibility (Cytotoxicity): Standardized scoring of cellular reactions (grade 0-4) according to USP and ISO 10993-10 requirements. This is an objective, measured outcome.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and design are based on established principles and manufacturing processes.

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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Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 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 on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The RH-900 consists of an active delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to an 80mA-min treatment. These electrodes are designed for a single-patient, one-application use.

This electrode is recommended for use with the Phoresor® Iontophoretic Drug Delivery Systems (Iomed, Inc., Salt Lake City, UT 84120). This system is a 9-volt battery powered, solid state, microprocessor-controlled device that controls current levels and duration, calculates total charge delivered and monitors current flow and electrode/skin impedance.

The RH-900 electrode consists of a dry, monolithic, impregnated nonwoven polyester fabric liquid containment element designed to be hydrated with an aqueous solution immediately prior to use. It also has a carbon conductive element and an adhesive tape border for skin fixation. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

The provided document describes the RH-900 Iontophoresis Electrode and its comparison to predicate devices, focusing on drug delivery capabilities and biocompatibility. The document does not describe a clinical study in the typical sense with patient outcomes, nor does it involve an AI/ML device. Therefore, it does not contain information about acceptance criteria in the context of clinical performance metrics like sensitivity, specificity, or accuracy, and does not provide details like sample sizes for test sets, expert qualifications, or MRMC studies for AI/ML devices.

However, I can extract the acceptance criteria (or rather, performance benchmarks) and the study (technical testing) used to demonstrate the device meets those benchmarks based on the information provided for this medical device (an iontophoresis electrode).

Here's the information structured to best fit your request, with strong caveats that this is not an AI/ML device study:

Acceptance Criteria and Study for Iomed RH-900 Iontophoresis Electrode

This document describes the safety and effectiveness of the RH-900 Iontophoresis Electrode by comparing its drug delivery and biocompatibility to predicate devices. It establishes performance through in vitro drug transport studies and in vivo dermal irritation studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Drug Delivery: The sample size for the in vitro hairless mouse skin model is not explicitly stated. The provenance is from a laboratory study ("in vitro by methods described by Petelenz et al., J Controlled Release 20 (1992), 55-56"). No country of origin is specified for the lab or samples.
• Biocompatibility (Primary Dermal Irritation): Rabbits were used. The specific number of rabbits is not provided. The study was conducted in accordance with FDA regulations for Good Laboratory Practices (GLP) and ISO 10993-10:2002.
• Biocompatibility (Cytotoxicity): The sample size for the in vitro cytotoxicity testing of the hydratable non-woven material is not specified. The testing followed GLP procedures and referenced USP and ISO 10993-10 requirements.

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

This type of information is not applicable as this is not a study assessing diagnostic performance by human experts. The "ground truth" for drug delivery was established by quantitative measurement of radiolabeled drug transport. The "ground truth" for dermal irritation and cytotoxicity was established by standardized laboratory testing protocols (GLP, ISO 10993-10) with objective scoring criteria, not by human expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI/ML product and does not involve human readers interpreting output.

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

Not applicable. This is a non-AI medical device. The "standalone" performance here refers to the device's inherent physical and chemical properties and interaction with biological systems, as tested in the laboratory.

7. The Type of Ground Truth Used

• Drug Delivery: Quantitative measurement of radiolabeled drug transport across hairless mouse skin (in vitro model).
• Biocompatibility (Primary Dermal Irritation): Objective scoring of dermal reactions in rabbits based on predefined scales (0.0 to 8.0), as per ISO 10993-10:2002 and GLP.
• Biocompatibility (Cytotoxicity): Standardized in vitro cytotoxicity assays yielding a grade on a 0-4 scale, as per USP and ISO 10993-10.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no 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, this question is irrelevant to the provided document.

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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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