(147 days)
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The Cortac Cortical Electrode is used intraoperatively for monitoring recordable electrical brain activity or Electroencephalography (EEG) when less invasive methods do not provide the electrophysiology data necessary. This invasive intracranial, subdural electrode recording is performed directly on the surgically exposed brain. This method is necessary when the seizure focus is to small and or to deep within the brain to produce a recordable EEG seizure. The Cortac Cortical Subdural strip and grid electrode are used in cases where it's necessary to establish a high degree of confidence in the electrical localization (Foci), seizure frequency, severity type and other electroclincal characteristics.
This 510(k) premarket notification describes a medical device called the "PMT Cortac Cortical Electrode," and primarily focuses on demonstrating its substantial equivalence to existing devices, rather than presenting a study proving performance against specific acceptance criteria for a novel AI or diagnostic algorithm.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. This document is a regulatory submission for a physical medical electrode, not a software algorithm.
However, I can extract information related to what might be considered "acceptance criteria" for a physical device, and any "studies" mentioned, even if they are fundamentally different from those associated with AI.
Here's the information extracted and organized to the best of what the document provides:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device, the "acceptance criteria" are related to its physical and functional specifications, sterilization, biocompatibility, and pyrogenicity. The "performance" is reported as meeting these specifications.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Material Properties | Pliability | Conform to brain topography without buckling/compression |
| Electrode Design | Contact with brain tissue | Maximizes contact, minimizes pockets for air/CSF |
| Electrical Continuity | Weld between contact/wire | Good electrical continuity with minimal resistance |
| Mechanical Strength | Weld tensile strength | Comparable to wire |
| Sterilization | Sterilization Method | 100% Ethylene Oxide (overkill method) |
| Sterility Assurance Level (SAL) | 10⁻⁶ probability of a nonsterile unit (validated) | |
| Pyrogenicity | Pyrogen Limit | 2.4 Eu/device (determined by Limulus Amebocyte Lysate Test) |
| Test Standard | USP Endotoxin Reference Standard | |
| Biocompatibility | Compatibility Class | Implant device, contacting tissue/bone, "A" class duration ( |
§ 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).