Search Results

The DAEHAN Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the, patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

DAEHAN Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

The provided text describes a 510(k) premarket notification for DAEHAN Adhesive Surface Electrodes. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not directly available or applicable in this context for a novel device performance study.

Instead, the submission focuses on comparing the new device to a predicate device based on technical characteristics and demonstrating that the new device meets relevant performance standards.

Here's how to address your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of an adhesive surface electrode, acceptance criteria are typically defined by recognized consensus standards. The document states that the device was tested against these standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified for any of the non-clinical tests. These tests are typically performed on a representative sample of the devices.
• Data Provenance: The tests would have been conducted by the manufacturer (Daehan Medical Systems Co., Ltd.) or a contracted lab. The country of origin for the device is the Republic of Korea. The data would be prospective, as the testing was conducted specifically for this submission.

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

• This concept is not applicable here. Ground truth, in the context of device performance, is established by adherence to recognized standards and test methodologies, not expert consensus on medical images or clinical outcomes. The "experts" would be the qualified personnel performing the laboratory tests according to the standards.

4. Adjudication Method for the Test Set

• Not applicable. Performance against engineering and biocompatibility standards does not typically involve an adjudication method like those used for expert consensus in clinical studies. Test results either meet the standard or they do not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reading images and improved by AI). The DAEHAN Adhesive Surface Electrodes are a non-invasive cutaneous electrode for stimulating/recording biopotential signals. Their effectiveness is demonstrated through adherence to electrical, biocompatibility, and safety standards, not through reader performance studies.

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

• Yes, in essence, standalone testing was done. The "performance testing" and "electrical safety" tests mentioned in the "Non-Clinical Test Summary" section evaluate the device itself (product performance and characteristics) against established standards without human interpretation or intervention in the diagnostic process. This is the equivalent of standalone performance for this type of device.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical performance and safety tests is defined by the requirements and specifications within the referenced consensus standards (e.g., ISO 10993-5, ISO 10993-10, AAMI/ANSI EC12, ASTM F1980-02, AAMI/ANSI ES 60601-1). These standards establish objective criteria for what constitutes acceptable performance and safety.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI algorithms that require a "training set." The device is a hardware component (an electrode).

9. How the Ground Truth for the Training Set was Established

• Not applicable. As a hardware device, there is no training set or ground truth established in this manner.

Ask a specific question about this device