(118 days)
The Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Gemore Reuseahle Self Adhesive Electrode / Wire series, snap series, and double side series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).
Gemore Reuseable Self Adhesive Electrode / Wire series and Double side series and Double side series are non-sterile, disposable laminated, flexible structures composed of materials commonly used in this application:
First Layer – White spun faced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylenc substrate, coated with biocompatible adhesive. Second Layer - Conductive plastic film.
Third Layer – Biocompatible conductive hydrogel coupling media
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices.
For the electrical connection, Gemore provides three different types:
Snap Series – Snap connection – 1.65" standard size of mail. Snap is provided to connect to the wire female snap.
Wire Series – Lead wire assembly – 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.
Double side series – adhesive gel was also provided at the reverse side of skin contact. With this adhesive side, the electrode can be mounted on the electricity conductive sufface of device without additional lead wire or snap.
The provided text describes a 510(k) submission for the "Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series." However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K052875 and K050788) for the purpose of a 510(k) clearance. This involves showing that the new device is as safe and effective as existing legally marketed devices, rather than meeting specific quantifiable performance targets derived from a clinical study with detailed acceptance criteria.
The information provided relates to:
- Biocompatibility: The gel used meets skin sensitivity testing criteria specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1.
- Electrical Safety: Electrical safety testing was conducted according to ANSI/AAMI EC12.
Since there is no detailed performance study with explicit acceptance criteria provided in the document, I cannot fill out the requested table or answer most of the questions.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The criteria are implicitly tied to demonstrating equivalence to predicate devices and meeting established safety standards (biocompatibility, electrical safety).
- Reported Device Performance:
- Biocompatibility: The gel used for skin contact "passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
- Electrical Safety: "We have conducted and completed the electrical safety testing according to the chosen performance standard, ANSI/AAMI EC12. The testing report was included in this submission."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No specific "test set" for performance evaluation is described. The biocompatibility and electrical safety tests would have involved specific samples, but the details of these are not provided in this summary.
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. No expert review for a "test set" to establish ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 electrode for neurostimulation, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for a performance study. For safety, the ground truth for biocompatibility is defined by established international standards (ISO 10993-1) and for electrical safety by ANSI/AAMI EC12.
8. The sample size for the training set
- Not applicable. No "training set" is described as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).