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Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver 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 proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.

The provided text describes a 510(k) premarket notification for "Adhesive Electrodes". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness for a new medical device. Therefore, the information typically found in a clinical study for a new device (like specific performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, or detailed ground truth establishment) is not present in this document.

The "study" that proves the device meets acceptance criteria, in this context, is a non-clinical test that demonstrates compliance with relevant standards and substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an adhesive electrode, the acceptance criteria are generally compliance with recognized standards and demonstration of substantial equivalence to a predicate device. Specific numerical performance metrics against acceptance criteria are not detailed in this summary for the product itself beyond standard compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document only mentions "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These would likely involve testing of manufactured units, but the number of units is not provided.
• Data Provenance: The tests are "Non clinical tests", implying laboratory testing of the device itself rather than data from human subjects. The manufacturing company, Top-Rank Health Care Co., Ltd, is located in China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is not applicable to this 510(k) submission. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI-driven devices. For an adhesive electrode, the "ground truth" is established by adherence to recognized performance standards (like ANSI/AAMI HF18:2001) and material biocompatibility standards (ISO 10993). No human experts are described as establishing "ground truth" for the performance of the adhesive electrode itself.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in diagnostic studies. This is not a diagnostic device and the referenced "Non clinical tests" are likely laboratory-based.

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

No. This is not a diagnostic device, and there is no mention or implication of AI or human readers being involved in its evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is not an algorithm-based device.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving it meets acceptance criteria is primarily:

• Compliance with established industry performance standards (ANSI/AAMI HF18:2001 for electrosurgical devices).
• Compliance with biocompatibility standards (ISO 10993).
• Demonstration of functional and material correspondence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. 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. See point 8.

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Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Top-Rank Adhesive Electrode." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to the device's technical performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input document. The document primarily focuses on the device's classification, intended use, and regulatory compliance for marketing purposes in the US.

Ask a specific question about this device