(80 days)
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
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Output | Meets specifications fully |
| Device Operation | Operates as described |
| Substantial Equivalence | Substantially equivalent to Iomed Phoresor II Model PM 900 (K982668), Iomed Phoresor II Model PM 800 (K933445), and R. A. Fischer MD-2 Iontophoresis Unit (K895365). Most closely similar to the Phoresor Model PM 800/900 units. |
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.
§ 890.5525 Iontophoresis device.
(a)
Iontophoresis device intended for certain specified uses —(1)Identification. 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 and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.