(253 days)
Catalog Numbers 2110-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (
PMT Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.)
The Subdural Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is too small and or too deep within the brain to produce a recordable EEG seizure. The Subdural Cortical Electrode strip and grid electrode are used in cases where it is necessary to establish a high degree of confidence in the electrical localization (foci), seizure frequency, severity type and other electro-clinical characteristics.
Macro Electrodes use 2mm, 3mm or 4.5mm diameter platinum circular recording discs. Micro Electrodes are single wires with the distal tip exposed and flush with the surface of the silicone. They are made of the same material used in the assembly of the Electrode. The Micro electrode allow for more precise definition of the Epileptic activity. They can be used solo or in combination with Macro recording discs.
The PMT device consists of one or more electrically contacts. The model number 2110 indicates a platinum alloy wire and platinum alloy electrode contacts. The electrodes' contacts are molded into a silicone rubber matrix in a fixed pattern. Insulated wires extend from each electrode through a flexible silicone tube to connector for EEG monitoring.
The electrode material for the 2110-XXX is 90:10 platinum iridium
This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity for diagnostic devices).
This submission is for PMT Subdural Cortical Electrodes, which are physical electrodes used for recording, monitoring, and stimulating electrical signals on the surface of the brain. The 510(k) process for such devices typically focuses on demonstrating substantial equivalence to existing predicate devices, primarily regarding their materials, design, technological characteristics, and intended use, rather than performance metrics like sensitivity or specificity.
Here's why the requested information isn't present in this document:
- Acceptance Criteria & Device Performance: The document states, "The technological characteristics of the product are not affected in this submission." This indicates that the device's fundamental function (recording/stimulating electrical signals) is considered equivalent to the predicate devices, and therefore, specific performance metrics for this function are not detailed or tested in this submission. The "performance" being discussed is more about the physical and electrical properties being similar to the predicate.
- No Clinical Study Details: This document does not describe any clinical trials or studies that would involve a test set, ground truth experts, adjudication, or comparative effectiveness studies (MRMC). The 510(k) process often relies on non-clinical testing (e.g., biocompatibility, electrical safety, mechanical integrity) and comparison to predicates, especially for devices like these electrodes.
- Ground Truth: For a device that records electrical signals, "ground truth" often refers to the actual physiological electrical activity. Establishing this for training or testing an algorithm based on these signals would be relevant for an AI device, but this is a physical electrode.
- Training Set: There's no mention of a training set because this is a physical device, not an AI algorithm that requires training data.
Therefore, it's not possible to populate the requested table and answer the study-related questions based on the provided text. The 510(k) summary focuses on establishing equivalence rather than presenting detailed performance study results with acceptance criteria.
If this were a submission for a diagnostic AI device, the content would be vastly different and would include the information you are asking for.
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).