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The INTEGRA™ Electrode Tunneling Needle aids in externalizing the leads of the Integra Cortical Electrodes to avoid contamination with patient fluids.

The INTEGRATM Electrode Tunneling Needle is a single use device intended to be used for externalizing the leads of the Integra Cortical Electrodes away from the craniotomy site for patients undergoing brain mapping procedures. The INTEGRATM Electrode Tunneling Needle creates a passage under the scalp through which the electrode leads can pass to a separate exit site without contaminating the lead contacts with patient fluids. The device consists of a stainless steel trocar with a plastic tunneling sheath attached to contain the leads during passage.

The Integra™ Electrode Tunneling Needle is a single-use device designed to externalize the leads of Integra Cortical Electrodes away from the craniotomy site during brain mapping procedures. The device creates a passage under the scalp, allowing electrode leads to pass to a separate exit site without contamination from patient fluids. It consists of a stainless steel trocar with a plastic tunneling sheath.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set. It refers to "all the samples" and "all the test results," indicating that multiple devices were tested. The testing involved "animal tissue," suggesting the provenance of the data is a pre-clinical, in vivo or ex vivo animal study rather than human data. The study appears to be prospective as it's described as "functional testing" and "testing was completed."

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

This type of information is not applicable to the reported testing. The "ground truth" here is objective physical performance (lead containment, absence of contamination, electrical resistance). There is no mention of expert human interpretation being required to establish these physical facts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., radiology reads) where there can be disagreement among experts. The reported testing focuses on objective physical measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used

The ground truth used for the performance testing was objective physical measurements and observations based on the functional performance of the device. This included:

• Visual confirmation of lead containment within the sheath.
• Visual confirmation of the absence of contamination/contact with animal tissue.
• Objective electrical resistance measurements of the electrode leads before and after tunneling.

8. The sample size for the training set

Not applicable. This device is a simple mechanical instrument, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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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

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.

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Radionics Epidural Peg, Sphenoidal and Foramen Ovale Depth Electrodes are indicated for intraoperative recording of electrical signals for epilepsy monitoring at the surface levels of the brain.

The Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes addressed in this PMN have similar intended uses, materials, technological characteristics, sterilization procedures, and packaging as the commercially available Radionics Cortical Surface and Depth Electrodes (K926424). These electrodes are used for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.

The provided text is related to a 510(k) submission for Radionics Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes for epilepsy monitoring. However, the document does not contain the detailed study information required to fill out the table and answer the specific questions about acceptance criteria and device performance as requested.

The document states that the device is "substantially equivalent" to a predicate device (Radionics Cortical Surface & Depth Electrodes K926424) based on similar intended uses, materials, technological characteristics, sterilization procedures, and packaging. This means that the regulatory submission primarily relies on demonstrating similarity to an already approved device rather than presenting new performance data against pre-defined acceptance criteria from a specific study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document, and what cannot:

Acceptance Criteria and Device Performance Study Information from K961942:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission focuses on substantial equivalence to a predicate device rather than establishing and testing against specific performance acceptance criteria.

2. Sample size used for the test set and the data provenance: This information is not provided. No specific test set or study data is mentioned beyond the comparison to the predicate device's characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. No test set requiring expert ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided.

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: This information is not provided. This device is an electrode for electrical signal recording, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not applicable/not provided. This is a physical medical device (electrodes) for direct signal recording, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.

8. The sample size for the training set: This information is not provided. No training set data is referenced.

9. How the ground truth for the training set was established: This information is not provided.

Summary of what is available from the document:

• Device Name: Radionics Epidural Peg, Sphenoidal, and Foramen Ovale Depth Electrodes
• Intended Use: For intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.
• Predicate Device: Radionics Cortical Surface & Depth Electrodes (K926424)
• Basis for Substantial Equivalence: Similar intended uses, materials, technological characteristics, sterilization procedures, and packaging as the predicate device. The submission asserts that the labeling contains instructions ensuring safe and effective use when followed by a physician.

The provided text only constitutes a "Summary of Safety and Effectiveness" that outlines the general information and the basis for substantial equivalence for a 510(k) submission. It does not include the detailed performance study data that would be found in a full submission, especially for novel devices or those requiring specific performance claims.

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