(207 days)
Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.
Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
This document is a 510(k) Summary for a medical device (Electrodes with silver conductive) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, reader studies, and sample sizes for training and test sets is not available in this type of regulatory submission.
The document primarily relies on bench testing and a comparison of technical specifications to a previously cleared predicate device to assert safety and effectiveness.
Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, "acceptance criteria" predominantly revolve around demonstrating substantial equivalence to a predicate device, as well as meeting basic biocompatibility standards and electrical resistance specifications. The performance is reported in terms of these comparisons.
| Acceptance Criterion (Inferred from comparison) | Reported Device Performance (Subject Device) | Comparison to Predicate (Neurotron Medical, Inc. - Theraknit Garments, K053214) |
|---|---|---|
| Intended Use | Deliver stimulation signals generated by a legally marketed TENS stimulating device to the body surface (hands, feet, wrist, elbow, knee). | Substantially Equivalent (SE) |
| Product Code | GXY | SE (Both GXY) |
| Regulation Number | 882.1320 | SE (Both 882.1320) |
| Regulation Class | Class II | SE (Both Class II) |
| Design (Shape) | Glove, Socks, Wristbands, Elbow Pads, Knee Pads Style | SE (Predicate also has Glove, Socks, Sleeve, Pads Styles - Note 1 explains differences do not raise safety/effectiveness issues) |
| Size | One size (Specific unstretched areas provided in cm2) | SE (Predicate had "All sizes" - Note 1 explains differences do not raise safety/effectiveness issues) |
| Conductive Surface | One size (Specific unstretched areas provided in cm2) | SE (Predicate had "All sizes" - Note 1 explains differences do not raise safety/effectiveness issues) |
| Impedance Parameters | 2 ohms resistance per inch | SE (Predicate: 7 ohms resistance per inch. Note 2 explains both are very low relative to stimulation current and considered safe/effective.) |
| Patient Contacting Material | Silver plated nylon | SE (Both silver plated nylon) |
| Biocompatibility | Complied with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization & Irritation) | SE (Predicate also complied with these standards) |
| Washable | Washable | SE (Both washable) |
| Labeling | Conform to 21 CFR Part 801 | SE (Both conform to 21 CFR Part 801) |
| Re-usable | For single patient | SE (Both for single patient) |
Regarding the specific questions you asked for deeper study details:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided: This document relies on bench testing and comparison to a predicate device, not a large-scale clinical test set for performance evaluation in the way an AI/software device would. The "test summary" only mentions "Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards." These would involve in vitro (cell culture) and potentially in vivo (animal, not human) tests, but not a "test set" of human data in the context of device performance as you might expect for an AI algorithm. The provenance would be the lab where these biocompatibility tests were conducted.
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)
- Not applicable/Not provided: There is no "ground truth" derived from expert consensus on patient data described, as this is a physical device (electrodes) and not an AI or diagnostic tool requiring such expert review of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided: See explanation for #3.
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/Not provided: This device is physical conductive electrodes, not an AI software. Therefore, MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided: This is not an algorithm. Bench tests were done to evaluate electrical properties and biocompatibility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided: For the physical and chemical properties assessed (e.g., impedance, biocompatibility), the "ground truth" is established by laboratory measurement standards (e.g., resistance meters, cell viability assays, irritation scores) rather than clinical expert consensus or pathology data.
8. The sample size for the training set
- Not applicable/Not provided: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided: See explanation for #8.
Summary regarding the nature of this submission:
This document is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device already legally marketed. For devices like these electrodes, this often means showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" here is not a clinical performance trial in the sense of evaluating diagnostic accuracy or clinical outcomes, but rather a series of bench tests (e.g., impedance, physical dimensions) and biocompatibility tests to ensure the device performs as expected and is safe for contact with the human body, compared against established standards and the predicate device's performance.
§ 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).