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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.

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

• Not applicable for an AI/diagnostic algorithm. This document describes a physical medical device. The "tests" mentioned (biocompatibility, pyrogenicity, sterilization validation) would involve laboratory samples of the device itself and biological testing, not a dataset of patient information.
• Data Provenance: Not applicable in the context of clinical data for an algorithm. The tests are performed on the manufactured device.

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

• Not applicable. This document does not describe a diagnostic algorithm requiring ground truth established by medical experts for a test set. The "ground truth" for the device's physical and biological properties is established through standardized laboratory testing protocols (e.g., USP standards for pyrogenicity, ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

• Not applicable. This relates to expert consensus for diagnostic interpretation, which is not relevant for this physical device's regulatory submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This refers to studies for AI-assisted diagnostic tools. The PMT Cortac Cortical Electrode is a physical tool for recording brain activity, not an AI.

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

• Not applicable. This refers to the performance of an AI algorithm independently.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For physical device properties: The "ground truth" is defined by established scientific and regulatory standards (e.g., ISO standards for biocompatibility, USP standards for endotoxins, validated sterilization cycle parameters) rather than expert medical consensus on patient data.
  • Biocompatibility: In vitro (cytotoxicity) and in vivo (sensitization, irritation, systemic toxicity) animal models following specific protocols.
  • Pyrogenicity: Chemical assay (Limulus Amebocyte Lysate Test) against a known standard.
  • Sterility Assurance Level: Microbiological challenge and validation studies for the sterilization process.

8. The Sample Size for the Training Set

• Not applicable. This refers to machine learning models.

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

• Not applicable. This refers to machine learning models.

Summary of "Studies" mentioned in the 510(k):

The document references several conformity assessments and validation processes, which can be interpreted as "studies" in the context of device approval:

• Sterilization Validation: "The type of sterilization is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a nonsterile unit of 10⁻⁶." This implies a microbiology validation study was performed.
• Pyrogenicity Determination: "The method of determination is the Limulus Amebocyte Lysate Test. The Bacterial Endotoxin test is conducted as described in the USP Endotoxin Reference Standard." This indicates laboratory testing was performed according to Pharmacopeia standards.
• Biocompatibility Testing: "The PMT Cortac Cortical Electrode is tested for biocompatibility per the General Program Memo # G95-1, the device is classified as an implant device, contacting tissue/ bone with an "A" class duration of contact (< 24 hours). The Cortac Cortical Electrode passed the tests for Cytotoxicity, Sensitization, Irritation and Systemic toxicity." This refers to specific biological safety tests performed according to regulatory guidance.
• Substantial Equivalence Comparison: The entire 510(k) is a "study" in the sense that it compares the new device to legally marketed predicate devices (Ojemann Cortical Stimulator, Wyler Subdural Strip Electrode, and PMT 2111-4 stainless steel Cortac Cortical electrode) to demonstrate it is "at least as safe and effective" and shares features like intended use, technology, and performance specifications. This is the primary "proof" within a 510(k).

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