(266 days)
The Lifecare electrodes are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices and EMS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
The Lifecare electrodes are constructed with four basic components: a wire; an insulation backing, a conductive surface; and a conductive adhesive gel. The devices function by conducting an electrical signal from a neurostimulation device through the wire. The signal is then dispersed from the wire across the conductive surface. Finally the signal is transmitted from the conductive surface through the conductive adhesive gel to the surface of the patient's skin. Everyway Self Adhesive Electrode, Wire series are non-sterile, disposable laminated, flexible structures composed of material commonly used in this application: First Laver - White spun laced nonwoven tape or white thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Laver - Conductive plastic film Third Layer – Biocompatible conductive hydrogel coupling media The electrodes are designed for single-patient/single 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 the electrodes. This connection point is compatible with standard, marketed Neurostimulation devices. For the electrical connection, Everyway provides one type of connection: Wire Series - Lead wire assembly - 4.5" - 6" wire with 0.080 in. diameter female socket connected to one side of the wire. These electrodes are: TKF5050 (5x5 cm square), TKF4040 (4x4 cm square), TKF50D (5cm round), TKF75D (7.5cm round), TKF4060V (4x6cm oval), TKF50100V (5x10cm oval), TKF4080 (4x8cm rectangle) and TKF50100 (5x10cm rectangle)
The provided text is a 510(k) Summary for a medical device (Lifecare electrodes) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and claims safety and effectiveness based on this equivalence.
However, the document does not contain any information regarding acceptance criteria, specific device performance studies, sample sizes, expert involvement, adjudication methods, or ground truth establishment. The absence of this information is typical for a 510(k) summary relying on substantial equivalence rather than new performance data for a novel device.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document states: "This device is safe and effective as the predicate devices cited above as detailed within this submission," implying that the justification for safety and effectiveness is primarily through comparison to already approved devices, rather than a new standalone performance study.
To directly answer your questions based solely on the provided input:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: The document claims "This device is safe and effective as the predicate devices cited above" but does not report specific performance metrics or data.
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set or ground truth establishment by experts is described for this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set requiring adjudication is described.
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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 (electrodes) is not an AI-driven, image-reading, or diagnostic device that would typically involve an MRMC study or human reader improvement with AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a passive medical device (electrodes), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific ground truth establishment is described for a performance study.
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The sample size for the training set:
- Not applicable as no machine learning or AI model requiring a training set is described.
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How the ground truth for the training set was established:
- Not applicable as no machine learning or AI model requiring a training set is described.
In summary: The provided 510(k) submission summary for the Lifecare electrodes relies on substantial equivalence to predicate devices (Lifecare electrodes K012463 and Gemore electrodes K062675) to demonstrate safety and effectiveness. It does not include new performance study data, acceptance criteria, or details of a study design as requested.
§ 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).