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The FREMAP Cranial Nerve Electrodes are designed for intraoperative (=

The device under review is a Facial nerve Root Evoked Muscle Action Potential (FREMAP) electrode. The electrode is used to elicit the muscle action potentials by electric stimulation directly to the facial nerve. It is commonly placed on the facial nerve or facial nerve root at the CP-angle and is used for monitoring (elicit) the muscle action potential response to preserve the facial nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle. The FREMAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System Neuromaster MEE-1000A or MEE-2000

The document provided is a 510(k) premarket notification for a medical device called the "FREMAP Cranial Nerve Electrode." It compares the device to several predicate devices to demonstrate substantial equivalence, rather than presenting a study where the device's performance is measured against acceptance criteria in a clinical or simulated clinical setting.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment cannot be fully provided from the given document.

However, I can extract the performance tests performed to demonstrate substantial equivalence, which serve as a form of acceptance criteria in the context of this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests conducted to establish substantial equivalence. It states that "Test requirements were met or a process monitor is in place to confirm compliance." Specific quantitative results or typical acceptance ranges for these tests are not provided in the document.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes for any of the performance tests listed. This is not a clinical study but rather a series of engineering and biological safety tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the data is retrospective or prospective. These are lab tests performed by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as the document describes engineering and biocompatibility tests, not a study requiring expert-established ground truth for device performance in a diagnostic or clinical decision-making context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable for the type of tests described.

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, an MRMC comparative effectiveness study was not done. The FREMAP electrode is a passive cranial nerve electrode for monitoring and stimulation, not an AI-powered diagnostic or assistive device for human readers.

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

• This information is not applicable. The device is a passive electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the performance tests mentioned (electrical resistance, continuity, tensile strength, dimensions, biocompatibility), the "ground truth" would be the engineering specifications and established ISO/ASTM standards for medical device materials and components, and biological safety standards (e.g., ISO 10993 for biocompatibility). The document does not detail these specific standards or criteria, only that the tests were performed and requirements were met.

8. The sample size for the training set:

• This is not applicable as the FREMAP electrode is not an AI/ML device that requires a training set.

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

• This is not applicable as the FREMAP electrode is not an AI/ML device that requires a training set.

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence through a comparison of technological characteristics and safety/performance testing of the device itself (an electrode), rather than an efficacy study of a diagnostic or AI-powered system involving clinical data and human interpretation. Therefore, many of the requested elements are not relevant or present in this type of regulatory submission.

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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.

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