(206 days)
The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.
The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.
This 510(k) summary describes a new medical device, the Target Sterile Electrode, and compares it to a predicate device, the Surgi-Stim Sterile Electrode, to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate device, Surgi-Stim Sterile Electrode. The study aims to demonstrate that the new Target Sterile Electrode performs equivalently or better than the predicate for these properties.
| Properties or Performance Characteristics | Acceptance Criteria (Predicate: Surgi-Stim Sterile Electrode) | Reported Device Performance (Target Sterile Electrode) |
|---|---|---|
| Electrode Backing Material | Non-woven | Non-woven |
| Method of attaching wire to electrode | Polyester Circular Disk | Polyester Circular Disk |
| Release liner card the electrode is stored on | Silicone Coated Paper | Silicone Coated Paper |
| Conductive Electrode Element | 2 Mil Vinyl With Carbon Loaded Pigment Coated With Silver / Silver chloride Ink | 2 Mil Vinyl With Carbon Loaded Pigment Coated With Silver / Silver chloride Ink |
| Hydrogel | Promeon RG 63B Formulation Thickness .032" | Comfort Gel A (Promeon RG 63B Formulation) Thickness .032" |
| Electrode Leadwire | Leadwire connector .080" or .059" | Leadwire connector .080" or .059" |
| Labeling | Sterile for Single Patient Use | Sterile for Single Patient Use |
| Labeling | States Potential Adverse Reactions is Skin Irritation | States Potential Adverse Reactions is Skin Irritation |
| Electrode Impedance @ 1000 Hertz | Less Than 100 Ohms | Less Than 100 Ohms |
| Force Required to Remove Wire From Electrode | More Than 5 Pounds of Force | More Than 6 Pounds of Force |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The comparison is based on material specifications and performance characteristics, suggesting laboratory testing rather than clinical study on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document does not describe the use of experts to establish ground truth. The comparison is based on objective material and physical property evaluations.
4. Adjudication Method
This document does not describe any adjudication method as it's not a study involving subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe a multi-reader multi-case comparative effectiveness study. The device is a cutaneous electrode, not an imaging or diagnostic device requiring human interpretation of results.
6. Standalone (Algorithm Only) Performance Study
No. This document does not describe a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device evaluation is based on objective physical and material properties and performance specifications of the predicate device. For instance, the "ground truth" for impedance is "Less Than 100 Ohms," and for wire removal force, it's "More Than 5 Pounds of Force."
8. Sample Size for the Training Set
This document does not specify a training set sample size. The comparison is based on characterization of the new device against an existing predicate.
9. How the Ground Truth for the Training Set Was Established
This document does not describe a training set or how its ground truth was established, as this is a device equivalence submission based on material and performance comparison rather than an AI/machine learning model. The 'ground truth' for comparison purposes is the established specifications and performance of the predicate device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).