(59 days)
Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
The proposed device, Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator, i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.
The intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.
The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.
The provided text is a 510(k) summary for Reno Medical Ltd.'s Adhesive Electrodes, and it specifically states: "No clinical study is included in this submission."
Therefore, a detailed description of acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment related to a clinical study cannot be provided from this document. The submission relies entirely on non-clinical testing to demonstrate substantial equivalence to a predicate device.
However, based on the non-clinical tests mentioned, we can infer the reported approach to meeting performance criteria.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with reported performance metrics for the proposed device in a clinical context. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
The comparison table (Table 1) shows that the proposed device is considered "Identical" to the predicate device (K132588) across various characteristics, including:
- Product Code: GXY
- Regulation Number: 21 CFR 880.1320
- Class: II
- Intended Use: Adhesive electrodes for use as disposable, conductive interface between patient's skin and Electrical Stimulators (TENS/EMS) for OTC use.
- Design Feature: Substrate / Wire / Hydro-Gel Scrim / Conductive Fiber Carbon Conductive Film / Liner
- OTC or Prescription: For OTC use
- Biocompatibility: Conforms to ISO 10993 series standards
- Label/Labeling: Complied with 21 CFR part 801
The acceptance criteria for these aspects are implicitly that the proposed device's characteristics match those of the predicate device and comply with relevant standards and regulations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because no clinical study was conducted. The "test set" in this context refers to the non-clinical tests' samples. The document does not specify the sample sizes or data provenance for these non-clinical tests.
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, as no clinical study with human subject data requiring expert ground truth was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with human subject data requiring adjudication was performed.
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. The device is an adhesive electrode, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device performance was assessed via non-clinical tests, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study with human subject data requiring ground truth was performed. For the non-clinical tests, the "ground truth" would be established by validated test methods and reference standards for material properties, electrical performance, biocompatibility, etc.
8. The sample size for the training set
Not applicable, as this is not an AI-powered device and no training set was used.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI-powered device and no training set was used.
§ 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).