(63 days)
The Auragen™ Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.
The cortical surface electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical electrodes vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested. The Auragen Cortical Electrodes are available with platinum/iridium contacts, with 4 to 64 contacts. The electrodes are connected to Integra recording cables themselves connected to the hospital EEG recording equipment.
The provided text describes a 510(k) submission for the Auragen™ Cortical Surface Electrodes, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish new performance metrics against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new AI/medical device (like sample sizes, ground truth procedures, multi-reader studies, etc.) is not applicable to this document.
However, the document does mention some performance testing related to safety. I will extract what is available and indicate where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Testing | ||
| MRI Compatibility | "MR Conditional" labeling claim as defined in ASTM F 2503-05 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment) | Device meets the "MR Conditional" labeling claim based on testing for radio frequency induced heating, magnetically induced displacement force, and torque. |
| MRI Artifacts | Localization of signal voids, considered "small in size in relation to the size and shape of the product." | Artifacts appeared as localized signal voids that were "small in size in relation to the size and shape of the product." |
| Sterility | Sterile | Provided sterile |
| Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Functional/Performance | ||
| Dimensional | Meet defined requirements of the product specification | Tested for dimensional performance and meets defined requirements. |
| Physical | Meet defined requirements of the product specification | Tested for physical performance and meets defined requirements. |
| Electrical | Meet defined requirements of the product specification | Tested for electrical performance and meets defined requirements. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "An array of cortical electrodes were subjected to MRI testing…" and implies individual electrodes were tested for dimensional, physical, and electrical performance. Specific numbers are not provided.
- Data Provenance: Not applicable in the context of clinical data for AI/medical device performance. This testing appears to be primarily bench testing (e.g., MRI compatibility, physical/electrical tests) and manufacturing process checks (sterility, non-pyrogenic).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for bench testing (e.g., MRI compatibility, dimensional checks) would typically be established by standardized testing protocols and measurements, not expert consensus in the way clinical ground truth is established.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (e.g., 2+1) are typically used for establishing ground truth from expert readings of medical images or data. Bench testing relies on objective measurements against predefined specifications.
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
- No. This is a 510(k) for a physical medical device (cortical electrodes), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device. Standalone algorithm performance is not applicable.
7. The type of ground truth used
- Bench Test Standards: For MRI compatibility, the ground truth was established by adherence to ASTM F 2503-05, a standard practice for marking medical devices for safety in the MR environment.
- Product Specifications: For dimensional, physical, and electrical performance, the ground truth was "defined requirements of the product specification."
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 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).