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The cutaneous, surface cup electrode system is intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

The cutaneous surface electrode (GCE, SCE, SCE, SCE' and CPES) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, gold, silver, conductive plastic, Ag-Ag/Cl, that have long been used for this intended purpose throughout the industry. The recording disc is permanently connected to a lead wire. This joint is then covered in a heat-shrink tube so as not to allow exposed lead wires and also to provide a strain relief. The lead wires are insulated with a Teflon insulation or equivalent. The lead wires are short and terminate in a small mass connector than conforms to DIN 42-802 for electrical safety. This small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802.

This 510(k) summary describes an EEG Surface Electrode System but does NOT contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone algorithm performance
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on the description of the device, its intended use, a comparison to predicate devices for substantial equivalence, and regulatory correspondence from the FDA. It does not provide any performance data or details of a scientific study as requested.

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The subdermal wire electrode (SWE) is intended for temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU). The SWE is a disposable, single use device. The SWE is intended for use in a similar manner to that of a subdermal needle electrode.

Subdermal Wire Electrode (SWE)

This document is an FDA 510(k) clearance letter for a Subdermal Wire Electrode (SWE). It does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter primarily:

• Confirms that the device, a Subdermal Wire Electrode (SWE), is substantially equivalent to legally marketed predicate devices.
• States its intended use: "temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU)."
• Classifies the device and outlines regulatory requirements.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or other performance-related information based on the provided text. This information would typically be found in the 510(k) submission document itself, not in the clearance letter.

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The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).

The pSWE is a disposable, single use device.

The pSWE is intended for use in a similar manner to that of a subdermal needle electrode.

Not Found

This document describes a 510(k) premarket notification for a medical device and is a regulatory approval letter. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for its intended use. It is a registration and approval document, not a clinical trial report or a performance study.

Therefore, I cannot provide the requested information from the given text.

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