Search Results

The Ives MR Conditional Cup Electrodes are 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 Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning.

The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging.

The cutaneous surface electrode (CPE) 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, conductive plastic and Ag-Ag/Cl, materials that have long been used for this intended purpose throughout the industry and compatible to the MR environment. The conductive cup electrode is permanently connected to a PVC insulated copper lead wire varying in length from 6" to 9". This joint is then covered in a heatshrink tube to provide a strain relief. The lead wires are staggered in length (6" to 9") and terminate in a small mass connector that conforms to DIN 42-802 for electrical safety. A blue sponge is provided to locate the lead wire termination off of the scalp and at the top of the patient's head. To permit EEG monitoring, 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. The Harness is disconnected for imaging. The electrode lead length is as short as possible to connect directly with the 10-20 EEG scalp site. This prevents coiling of the lead wires and as short as possible lead length to reduce or eliminate the RF heating antenna effect during MR scanning sequences. Electrode and lead materials are selected to avoid use of any magnetic ferrous metals.

The provided document describes the FDA 510(k) premarket notification for the Ives MR Conditional Cup Electrode, focusing on its substantial equivalence to predicate devices and its MR Conditional properties.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one might expect in a detailed study report. However, it implicitly defines acceptance criteria through its claims of MR Conditional compatibility and the supporting non-clinical testing.

Here's a reconstruction of the implicit acceptance criteria and the device's performance based on the non-clinical testing section:

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

• Sample Size for Test Set: The document mentions "clinical testing" for image artifact, but does not specify the sample size (e.g., number of electrodes, number of subjects/patients) used for this testing.
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission and the company name ("Ives EEG Solutions, Inc." and "Newburyport, Massachusetts"), it is highly probable the testing was conducted in the United States. The document is a regulatory submission, not a research paper, so detailed provenance is not typically included here unless specifically requested by the FDA for certain study types. The testing described is non-clinical (thermal, electromagnetic compatibility) and clinical (image artifact assessment), implicitly making it prospective for the purpose of this submission.

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

This information is not provided in the document. The testing described focuses on physical properties (heating, artifact) rather than diagnostic accuracy or interpretation requiring ground truth established by medical experts for a test set. The "clinical testing" mentioned for image artifact would typically be assessed by radiologists, but the number and qualifications are not stated.

4. Adjudication Method for the Test Set

This information is not provided in the document. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation of data, such as diagnostic accuracy studies, which is not the primary focus of the non-clinical and basic clinical compatibility testing described here.

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

No, an MRMC comparative effectiveness study was not done and is not applicable here. This document is about the MR compatibility and basic safety of an EEG electrode, not about the diagnostic effectiveness of an AI algorithm or human readers. The device itself is an electrode, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone study of an algorithm performance was not done. The device is an electrode, not an algorithm.

7. Type of Ground Truth Used

For the non-clinical testing (thermal, magnetic compatibility), the "ground truth" is established by:

• Physical measurements and scientific principles: Temperature rise is directly measured. Magnetic field interactions are assessed based on material properties and measured forces/torques.
• Established MR safety standards: Testing methods and thresholds are derived from recognized industry standards and regulatory guidance for MR compatibility.

For the "clinical testing" of image artifact, the "ground truth" implicitly refers to the direct observation and measurement of the artifact on MR images by qualified personnel (likely radiologists or MR physicists), compared against a baseline expectation or standard for acceptable artifact. It's not ground truth in the sense of a disease diagnosis but rather a direct physical effect.

8. Sample Size for the Training Set

Not Applicable. This device is a physical medical instrument (an electrode), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The non-clinical and clinical testing performed relates to the physical safety and compatibility of the device.

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

Not Applicable. As there is no AI algorithm and no training set, there is no ground truth to be established for a training set.

Ask a specific question about this device