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Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.

Guardian 150 electrode is a single-patient, single use, self-adhering electrode for use with TENS and NMES, and available in cloth (models 150. 151. 152 and 3637), pre-wired (model 3637), snap (models 150, 151 and 152) and pin style (model 3637) configurations. It is latexfree.

The provided text does NOT describe acceptance criteria for a medical device or a study that proves the device meets specific acceptance criteria.

Instead, the documents are:

• A 510(k) summary for the "Guardian 150 electrode" from SelectiveMed™ Components, Inc.
• An FDA letter confirming the substantial equivalence of the Guardian 150 electrode to predicate devices.
• The "Indications for Use" for the Guardian 150 electrode.

These documents establish the device's classification, intended use, and substantial equivalence to existing devices. However, they do not contain any information regarding specific performance acceptance criteria or a study that outlines how these criteria were met.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies, as that information is not present in the provided text.

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Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

The Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The SMC Buffered Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCl) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) summary for a medical device (Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes), which primarily focuses on demonstrating substantial equivalence to already legally marketed predicate devices. It describes the device, its intended use, and lists predicate devices, but it does not include performance data or studies against specific acceptance criteria.

Therefore, I cannot fulfill your request for that information based on the provided input.

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Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.

The iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. The iontophoretic technology operates on the principle that an electic potential will cause ions in solution to migrate according to their electrical charges. Further, the quantity and distribution of a drug delivered into or across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, strength of the electircal current being applied, electrode composition, duration of current flow and several other factors. The Medion™ is a battery-powered, solid state, microprocessor controlled 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) premarket notification for the Medion™ 6000 Series Iontophoresis Device. This submission focuses on demonstrating substantial equivalence to predicate devices based on bench testing. As such, it does not involve the types of studies typically associated with AI/ML-driven devices, which would require the specific data points you've requested (such as sample sizes for test/training sets, expert qualifications, MRMC studies, etc.).

Therefore, I cannot provide all the requested information because the provided document does not contain information related to AI/ML device performance or clinical studies with human readers, training sets, or ground truth establishment in the way you've outlined.

However, I can extract the available information regarding acceptance criteria and the study performed:

Acceptance Criteria and Device Performance

Study Details (Based on available information in the document)

• Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the device itself and its performance against specifications, not a dataset for an algorithm. The study was non-clinical and involved bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to human-labeled data. Here, the "ground truth" equivalent would be the engineering specifications and established performance of predicate devices.
• Adjudication method for the test set: Not applicable. This concept is relevant for reconciling expert disagreements on ground truth annotations, which isn't present in this type of study.
• 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 document describes a traditional medical device (iontophoresis device) and not an AI/ML-driven device. Therefore, no MRMC study, human readers, or AI assistance is mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This section is not applicable as the device is not an algorithm.
• The type of ground truth used: For the purposes of demonstrating substantial equivalence, the "ground truth" was the engineering specifications for the device's electrical output and operational characteristics, and the established regulatory status and performance of the predicate devices.
• The sample size for the training set: Not applicable. There is no AI/ML algorithm involved that would require a training set.
• How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided document describes a non-clinical bench test to confirm that the Medion™ 6000 Series Iontophoresis Device meets its electrical output specifications and operates as described, demonstrating substantial equivalence to its predicate devices. This is a common pathway for traditional medical device clearances and does not involve AI/ML-specific study designs.

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Io-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.

The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.

The provided document, K993081, describes the IO-DRIVE Iontophoresis electrode system. This submission is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving novel safety and effectiveness through extensive clinical trials.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective study details). The "performance evaluation" mentioned is very high-level and does not provide these specifics. For a 510(k) submission focused on substantial equivalence, such detailed clinical trial data with specific test sets and provenance is often not required if the device is sufficiently similar to predicates and performance can be established through bench testing or limited clinical data.

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

This information is not provided in the document. Given the nature of a 510(k) submission relying on "performance evaluation" for substantial equivalence, it's unlikely that an extensive expert-adjudicated test set in the traditional sense was used to establish ground truth for a novel "device performance" metric. Instead, the "ground truth" for comparison would be the established performance characteristics of the predicate devices.

4. Adjudication Method for the Test Set

This information is not provided.

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

An MRMC comparative effectiveness study was not performed or reported in this document. The submission is for a medical device (electrode system), not an imaging or diagnostic AI algorithm, so an MRMC study would generally not be applicable in this context.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed or reported. This device is an electrode system for drug delivery, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily performance characteristics and established safety/effectiveness profiles of the predicate devices. The IO-Drive electrode system's "performance evaluation" aimed to show similarity to these predicates. The FDA's substantial equivalence determination implies that the new device is as safe and effective as the predicate devices based on available information, which might include design comparisons, material testing, and limited functional testing, rather than an independent "ground truth" based on clinical outcomes.

8. Sample Size for the Training Set

This information is not applicable/not provided. The IO-Drive system is an electrode, not an AI algorithm, so there is no concept of a "training set" in this context.

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

This information is not applicable/not provided for the same reasons as above.

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