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The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP) and the electroencephalographic/evoked potentials reading is a completely non-invasive procedure that can be applied repeatedly to patients, normal adults, and children with virtually no risk or limitation. The electrodes are delivered non sterile and are available in reusable and disposable versions.

This document describes the acceptance criteria and study information for Technomed Europe's Cutaneous Electrodes (Cup Electrodes).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text describes a 510(k) submission for a cutaneous electrode (Cup Electrodes). In the context of a 510(k) submission for this type of device, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is primarily achieved through non-clinical bench testing to confirm performance characteristics. The document does not provide specific quantitative acceptance criteria or detailed device performance metrics in a structured table.

However, based on the information provided, the implicit acceptance criteria are:

• Substantial Equivalence: The design, materials, chemical composition, packaging, and other technological characteristics are equivalent to the predicate device (K061148: Rhythmlink Disc Electrodes).
• Performance Characteristics: The device confirms its performance characteristics through bench testing.
• Safety and Effectiveness: The device is deemed safe and effective for its intended use.

The reported device performance is that the "comparison to the predicate devices demonstrate that the cup electrodes are safe and effective and are substantially equivalent to the predicate devices."

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

The document states, "Technomed Europe has been bench testing the Cup Electrode to confirm performance characteristics of this device."

• Sample Size for the Test Set: Not specified. The document does not provide a number of units tested or a breakdown of the tests conducted.
• Data Provenance: The bench testing was conducted by Technomed Europe. This is a non-clinical, in-house study. The country of origin for the data is The Netherlands, where Technomed Europe is located. The study is prospective in nature, as it involves testing a newly developed device.

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

This information is not applicable. The device is a cutaneous electrode, and its performance evaluation for substantial equivalence primarily relies on non-clinical bench testing rather than the establishment of a "ground truth" by experts in the context of diagnostic interpretation. The evaluation focuses on physical and electrical properties, not interpretive results requiring expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where multiple readers or experts evaluate a case and their opinions need to be reconciled to establish a ground truth. Since this product involves bench testing and not clinical interpretation by experts, an adjudication method is not relevant.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Technomed Europe Cup Electrodes are physical medical devices (electrodes) used for signal acquisition, not diagnostic interpretation, and therefore, an MRMC study is not relevant to their evaluation. Furthermore, the device does not involve AI.

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

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI system. It is a physical medical device. The "performance" assessment focuses on its physical and electrical characteristics through bench testing, not algorithmic performance.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically understood in diagnostic AI (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For this device, the "ground truth" or reference standards for performance are established through:

• Predicate Device Characteristics: The design, materials, and technological characteristics of the legally marketed predicate device (K061148: Rhythmlink Disc Electrodes) serve as a de facto reference for substantial equivalence.
• Bench Testing Standards: Industry standards and accepted methodologies for evaluating the physical and electrical performance of cutaneous electrodes would be the "ground truth" for the non-clinical tests performed.

8. The Sample Size for the Training Set:

This information is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical electrode and does not involve any machine learning components, so there is no training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

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