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The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The ATLAS Stim Headbox itself is an accessory to the ATLAS Neurophysiology System and ATLAS STIM Headbox software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The ATLAS Stim Headbox can operate only when so connected and with the Pegasus and ATLAS Stim Headbox software; it cannot serve as a stand-alone stimulator.

The ATLAS Stim Headbox (ASHB) is a clinical headbox that allows 3rd party Macro electrode contact electrode arrays (ECoG, depth electrodes, grid array, strip array, etc.) to interface with the Neuralynx ATLAS Neurophysiology System, previously cleared in 510(k) K110967, which includes the Pegasus Software.

The ATLAS Stim Headbox is an accessory to the ATLAS Neurophysiology System (formerly known as SpikeTrax in K110967). The ATLAS Stim Headbox hardware consists of an encased amplifier and embedded firmware for generation and delivery of stimulation energy. The ATLAS Stim Headbox can deliver electrical stimulation current under the control of the associated ATLAS Stim Headbox Software which interfaces via a fiber optic ethernet communications connection.

The provided FDA 510(k) clearance letter and summary for the ATLAS Stim Headbox do not contain information about acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing (electrical safety, mechanical integrity, evoked response, electroencephalograph, and software regression).

Therefore, I cannot fulfill most of your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document primarily covers the safety and basic functional performance of the hardware and software as a medical device accessory, not its diagnostic or therapeutic accuracy for specific clinical outcomes that would require clinical studies with ground truth.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

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

The document does not present "acceptance criteria" in the sense of a clinical benchmark (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it describes compliance with recognized standards and successful completion of verification and validation tests for safety and technical performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the validation performed is non-clinical (device testing against engineering specifications and international standards), not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth for device performance in this context is defined by international standards (e.g., IEC 60601) and engineering specifications. No clinical expert adjudication was mentioned for device functionality.

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

This information is not applicable/provided. No clinical adjudication method was mentioned for device functionality.

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

An MRMC study was not done. The device is an accessory for stimulation and recording of neural activity, not an AI-powered diagnostic tool for interpretation by human readers.

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

This is not applicable in the context of an "algorithm only" performance for a diagnostic task. The ATLAS Stim Headbox is a hardware accessory with embedded firmware and associated software, designed to be used in conjunction with other systems and by clinical professionals. It cannot operate as a stand-alone stimulator, as explicitly stated: "it cannot serve as a stand-alone stimulator."

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

The "ground truth" for the device's substantial equivalence and safety is primarily based on:

• International standards and engineering specifications: Compliance with IEC 60601 series, IEC 62304, IEC 62366.
• Functional verification: Demonstrating that the device's electrical characteristics (e.g., charge per phase, instantaneous current sum) meet safety limits and design specifications.
• Predicate device characteristics: The claim of substantial equivalence is made against the technical specifications and known performance of the predicate devices.

8. The sample size for the training set

This is not applicable/provided. The document describes a hardware device and its control software. There is no mention of "training set" in the context of machine learning for a diagnostic algorithm. Software regression testing refers to the iterative testing of the software itself against predefined functionalities and bug fixes, not the training of a model on a dataset.

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

This is not applicable/provided as there is no "training set" in the context of machine learning for a diagnostic algorithm.

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Layer 7-T cortical electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).

The Layer 7-T is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).

The overall Layer 7-T consists of a sterile thin film 1024-electrode array connected to a more rigid PCB package (known as the headstage) with ribbon cables. Each ribbon cable connects to 64 channels from the electrode array. There are a total of 16 ribbon cables in the headstage, connecting 1024 electrodes on the array. The device is also provided with an intermediary yoke cable that connects the ribbon cables from the Layer 7-T headstage to standard EEG equipment via 64 standard DIN connectors. A yoke stand is also provided as an optional accessory that allows up to 16 yokes to be stacked. Surgical accessories are provided with the array and are intended to aid in deployment of the array.

The system allows the surgeon to place electrode arrays on the surface of the brain through burr holes. The inserted portion of the device can be retrieved following use by pulling the electrode array through the burr hole.

The thin film electrode array is designed to operate in a fashion identical to the currently used ECoG arrays, in that it is to be placed on the surface of the brain to interface with brain tissue through electrical recording and stimulation.

The electrode array consists of a polyimide substrate with platinum electrodes and associated electrically connecting traces and another layer of polyimide on top. A polyimide pocket is adhered via silicone to the backside of the electrode array tip. The array also contains gold radiopaque markers embedded in the silicone pocket adhesive. A rigid stainless steel radiopaque stylet is temporarily placed in the pocket during electrode array deployment.

The overall Layer 7-T system, including the yoke, is intended for single use only. The Layer 7-T is a passive device and only receives power from a connected FDA-cleared EEG system. It does not have any wireless capabilities and does not contain any software. It is not MRI-compatible. It is only intended for use in a professional healthcare environment.

The provided text is a 510(k) summary for a medical device called "Layer 7-T," a cortical electrode. While it details numerous performance tests, biocompatibility studies, electrical safety, human factors, and animal testing, it does not describe a study involving human-in-the-loop performance with an AI component or any study that would require acceptance criteria related to diagnostic accuracy, sensitivity, specificity, or reader improvement.

The document states: "The Layer 7-T is a passive device and only receives power from a connected FDA-cleared EEG system. It does not have any wireless capabilities and does not contain any software." This clearly indicates that the device itself is a passive hardware component and does not incorporate AI or any form of software that analyzes or interprets data to provide a diagnostic or assistive output that would require a "study that proves the device meets the acceptance criteria" in the context of AI performance.

Therefore, I cannot provide the requested information regarding AI acceptance criteria or a study proving device performance in that context, as the provided document explicitly states the device does not contain software or AI.

However, I can extract the general "performance data" that demonstrates the device's safety and effectiveness relative to its predicate, as described in the document.

General Performance Data and Acceptance (Based on Equivalence to Predicate)

The acceptance criteria for the Layer 7-T are implicitly defined by its ability to demonstrate substantial equivalence to the predicate device (Ad-Tech Subdural Electrodes, K191186) through various non-clinical tests. The goal is to show that it is "as safe and effective" as the predicate, even with minor technological differences.

1. Table of Acceptance Criteria and Reported Device Performance:

Since there's no AI or diagnostic software, the "acceptance criteria" for the device relate to fundamental device properties, material safety, and functional performance, with the implicit criterion being "Pass" compared to established standards or a predicate.

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

The document describes non-clinical bench testing and animal studies. There is no "test set" in the context of an AI model's performance on patient data.

• Bench Testing: Sample sizes are not explicitly stated for most bench tests (e.g., durability, electrochemical performance), but it's implied that sufficient samples were tested to demonstrate compliance.
• Animal Testing: 16 female Göttingen swine were used, divided into a 1-week and a 6-week implant duration cohort.
• Data Provenance: The animal study was a GLP (Good Laboratory Practices) study, indicating a controlled, prospective experimental setting. The origin of the animals is not specified beyond "Göttingen swine."

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

Not applicable, as this is neither an AI device nor does it involve a "test set" requiring expert-established ground truth in the diagnostic sense. The ground truth for biocompatibility and animal study outcomes would be established by qualified pathologists and veterinarians, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set:

Not applicable, as there's no AI model output requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not performed. This type of study is typically used for AI-assisted diagnostic devices to assess the impact of AI on human reader performance, which is not relevant for this passive hardware device.

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

Not applicable, as the device is a passive hardware component with no embedded algorithm or software for standalone performance evaluation beyond its physical and electrical characteristics.

7. The Type of Ground Truth Used:

• Bench Testing: Ground truth is based on engineering specifications, physical measurements, and adherence to international standards (e.g., ASTM, ISO, IEC).
• Animal Testing: Ground truth was established through neurological evaluations, gross and microscopic pathological analysis performed by qualified personnel (implied).

8. The Sample Size for the Training Set:

Not applicable, as there is no AI or machine learning model that requires a training set.

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

Not applicable, as there is no AI or machine learning model.

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The WISE Cortical Strip is intended for intraoperative (≤24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.
The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.

The WISE Cortical Strip is medical device composed of:

• A strip containing 4 electrodes that is positioned during surgery on the exposed surface of the brain
• A cable composed of 4 conductive channels intended to transfer electrical signals to and from a commercial connecting cable.
  The device is intended to be used only for intraoperative monitoring during brain surgery and is not implanted.
  The WCS is a sterile, single-use device, individually packaged with a shelf life of 18 months.
  Manufacture of the device uses a WISE proprietary patented technology called "Supersonic Cluster Beam Implantation" (SCBI). This technology produces flexible conductors by enabling thin conducting metal layers to be deposited on a silicone substrate. This enables the strip to be flexible and conform to the brain's surface.
  The WCS is intended to be used with FDA-cleared IONM equipment and a reusable connecting cable. The device does not include (as an accessory or component) these separate devices.

The provided text describes a 510(k) premarket notification for the WISE Cortical Strip (WCS). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document details:

• Device Description: The WISE Cortical Strip is a medical device composed of a strip with 4 electrodes and a cable for transferring electrical signals. It's intended for intraoperative use (≤24 hours) with recording, monitoring, and stimulation equipment.
• Intended Use: Aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries for recording, monitoring, and stimulation of electrical signals on the brain surface.
• Technological Characteristics Comparison: Compares the WCS to predicate devices (Ad-Tech Intraoperative Strip Electrode and Ad-Tech Intraoperative Subdural Electrode). Key similarities include intraoperative use, sterilization method, electrode configuration, and stimulation charge density. Differences include contact materials (Platinum only for WCS vs. Platinum:Iridium or stainless steel for predicate), non-pyrogenic labeling for WCS, and the unique Supersonic Cluster Beam Implantation (SCBI) manufacturing process for WCS.
• Non-Clinical Performance Data: A table of bench testing performed, including:
  • Labeling and packaging integrity verification
  • Label indelibility test
  • Dielectric strength test
  • Device integrity verification
  • AC impedance test (with a specific acceptance criterion of ≤ 10 kΩ @ 10 Hz)
  • Insulation test
  • Compatibility with recorders test
  • Compatibility with stimulators test
  • Stimulation and metal release test
  • Bias current tolerance test
    All tests passed.
• Biocompatibility Testing: Performed according to ISO 10993-1 for an externally communicating device with tissue and cerebrospinal contact (limited duration ≤ 24 hours). Tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Pyrogenicity, Acute Systemic Toxicity, and Indirect Hemolysis. All results indicated the device materials are safe.
• Sterilization and Shelf-Life Testing: Validated Ethylene Oxide sterilization (SAL of 10-6) and established an 18-month shelf-life via accelerated aging.

What is missing for the requested information regarding AI/ML device acceptance criteria and studies:

The provided text describes a hardware medical device (cortical strip electrode), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth establishment," "number of experts," "adjudication methods," and "MRMC studies" as they apply to AI/ML performance evaluation are not applicable and are not present in this document.

The "acceptance criteria" presented are for the physical and electrical performance of the electrode itself (e.g., AC impedance ≤ 10 kΩ), mechanical integrity, biocompatibility, and sterility, which are standard for such devices.

Therefore, it is impossible to complete the requested table and answer the specific questions about AI/ML device performance from the provided document.

If the intent was to find information on a software component that uses AI/ML with the data from this cortical strip, that information is not in this FDA submission summary. This document focuses solely on the WISE Cortical Strip hardware.

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The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.

The Recording and stimulating for Central Nervous System electrodes are used for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci. The electrodes are multipole arrays of electrodes that are positioned on the surface of the brain. The electrode must be designed to follow the complex anatomy and they can assume different conformations in relation to the requests of clinical needs. The neurosurgeon is the person recommended for electrode placement. The electrodes have to be used under the direction of the neurosurgeon and other skilled physicians to support their clinical needs.

The provided text describes the acceptance criteria and the results of various performance tests for the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (hereinafter referred to as "the device").

1. Table of Acceptance Criteria and Reported Device Performance:

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The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping.

The DIXI Medical Intraoperative Subdural Electrode (Strips and Grids) is an intra-cranial electrode used intraoperatively on the surface of the brain. The device is designed for electroencephalography (EEG) recording and brief stimulation for brain mapping purposes. The DIXI Medical Intraoperative Subdural Electrode consists of circular contacts sandwiched between two layers of silicone substrate. The brain contacting side of the silicone substrate body has material removed to expose an amount of contact surface area. Insulated wires extend from each contact through a flexible tube which terminates in connectors for direct connection to user's equipment.

The device in question is the DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids), which are intended for intraoperative use (less than or equal to 24 hours) for recording and stimulating electrical signals on the brain's surface to support brain mapping.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical and biocompatibility testing. The acceptance criteria are implicit in the "Objective" column for non-clinical tests and the "Conclusion" column for biocompatibility tests, which all show a "Pass" result indicating the device met the predefined safety and performance standards for each test.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document mentions that nonclinical testing was conducted on specific product references: C10-04CIOM, C10-08AIOM, and C10-16CIOM, C10-16AIOM for biocompatibility. However, it does not specify the exact number of units of each product that were tested for each individual test. It also refers to testing on "baseline and aged devices," with aged devices undergoing three sterilization cycles, accelerated aging (5 years), extreme climatic conditions, and transport tests, implying multiple units were used for aging studies.
• Data Provenance: The document does not explicitly state the country of origin of the data. It is a submission by DIXI Medical, located in France. The testing was conducted according to international standards (ASTM and ISO). The data is from nonclinical, pre-market testing, not patient-derived data (retrospective or prospective).

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

This information is not applicable. The studies described are non-clinical (device performance and biocompatibility) and do not involve expert-established ground truth in the context of clinical decision-making or diagnosis. The "truth" or acceptance criteria are based on established engineering and biological safety standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on patient data. The current studies are bench tests and animal studies (for biocompatibility).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI. The DIXI Medical Intraoperative Subdural Electrodes are physical medical devices for electrical signal recording and stimulation, not for diagnostic image interpretation or AI-driven analysis.

6. Standalone Performance Study:

Yes, standalone (algorithm only without human-in-the-loop performance) studies were done for the device's physical and electrical characteristics and biocompatibility. The reported "Pass" results for all tests indicate the device met its predefined performance and safety criteria independently. The non-clinical and biocompatibility tests were conducted directly on the device itself or its materials.

7. Type of Ground Truth Used:

The "ground truth" for these tests refers to established engineering specifications, regulatory standards, and biological safety limits. For example:

• Nonclinical Testing: Ground truth is defined by the expected electrical (e.g., ability to transmit signal, resistance), dimensional, and mechanical properties of the device as per its design and intended use, validated against engineering standards.
• Biocompatibility Testing: Ground truth is based on the biological response limits defined by standards like ISO 10993, ensuring materials are non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic, non-hemolytic, and non-toxic.

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The development of the device would have involved iterative design and testing, but not a formally defined "training set" for an algorithm.

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

This information is not applicable for the reasons stated in point 8.

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iCE-SG Subcutaneous Electrode Arrays are intended for temporary (

The iCE-SG Subcutaneous Electrode Arrays are intended for use with recording and monitoring equipment for the purpose of recording electroencephalograph (EEG) signals. The subject device allows for continuous EEG monitoring in the subcutaneous space. The iCE-SG Subcutaneous Electrode Arrays can connect to commonly used electrophysiology systems. The subject device is provided sterile and for single patient use in hospitals by healthcare professionals (HCPs).

A kit includes the following components:

1. Preparation box
2. Insertion kit box
3. Two iCE-SG electrode boxes

Here's an analysis of the acceptance criteria and supporting study for the iCE-SG Subcutaneous Electrode Arrays, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it details various tests to demonstrate safety and equivalence to a predicate device. The "results" column below reflects the outcomes reported for these tests, which were deemed sufficient for demonstrating substantial equivalence.

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Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (

Cortical Electrode (Per FDA Classification)

This document is a Traditional 510(k) Summary for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). It asserts substantial equivalence to a predicate device (AD-TECH Subdural Cortical Electrodes) rather than claiming specific performance criteria and a study to meet them. Therefore, the requested information on acceptance criteria and a study proving the device meets them cannot be directly extracted as it would for a claim of new performance.

However, I can interpret the document's content to provide related information about the device's safety and effectiveness testing where it implicitly establishes "acceptance criteria" through conformance to recognized standards and successful test results.

Here's a breakdown of the available information, structured to align as closely as possible with your request:

Acceptance Criteria and Device Performance (Indirectly Derived from Safety and Performance Testing)

The document focuses on demonstrating substantial equivalence to a predicate device, which means proving the new device is as safe and effective as the legally marketed predicate. The "acceptance criteria" are generally implied to be compliance with relevant standards and successful completion of various tests, demonstrating that the device performs as intended and does not raise new questions of safety or efficacy.

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The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (

The device under review is a family of Subdural Electrodes. These electrodes provide surface brain contact to support recording, monitoring and stimulation from user supplied equipment.

The family of Subdural Electrodes under review are used under the direction of neurosurgeons and other skilled physicians to support their clinical needs for subdural electrodes on the brain. Based upon the needs of their clinical practice and particular patients, various 2-dimensional geometric shapes (length and width) resulting in variations of Subdural Electrode body shapes and orientation configurations are necessary.

All variations of Subdural Electrodes under review consist of the same materials and fundamental design as the predicate Subdural Electrodes. Either round discs or rectangular electrode contact material are sandwiched between two layers of silicone substrate electrode body material. The brain contacting side of the silicone substrate body has material removed to expose an amount of electrode contact surface area. The subdural electrode wires between the electrode contact and connector contacts at the most distal end of the subdural electrode tail pass through a tube for interface with the user's equipment.

Here's a breakdown of the acceptance criteria and study information for the Ad-Tech Subdural Electrodes based on the provided document:

This document is a 510(k) summary for a medical device, which typically aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be found in a PMA (Premarket Approval) application. Therefore, you will find information related to design and performance verification rather than large-scale clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid)

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The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (

The provided text is a 510(k) summary for the NeuroOne Cortical Electrode. This document outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical device clearance. It does not contain information about a study proving the device meets acceptance criteria in the context of a standalone or comparative effectiveness clinical study with performance metrics like sensitivity, specificity, or F1-score.

Instead, the "acceptance criteria" discussed here refer to the regulatory requirements for demonstrating equivalence to a legally marketed predicate device. The "study" proving acceptance criteria is a series of engineering and biocompatibility tests intended to show that the differences between the new device and the predicate do not raise new questions of safety or efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format typically used for studies evaluating diagnostic or predictive AI systems, nor can I answer questions related to sample size for test sets, ground truth establishment by experts, adjudication methods, or MRMC studies. These elements are not applicable to the type of regulatory submission described.

Here's a breakdown of what can be extracted from the document regarding the criteria and the "study" (testing) that supports the device:

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

The acceptance criteria are implicitly defined by the benchmarks set by the predicate device and relevant international standards. The "reported device performance" refers to the successful completion of various tests deemed sufficient to demonstrate equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided because the "testing" is primarily engineering and bench testing, not a clinical study on patient data. There isn't a "test set" of patient data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth as defined for clinical studies (e.g., expert consensus for diagnostic accuracy) is not part of this 510(k) submission, which focuses on device safety and performance equivalence through engineering and biocompatibility testing.

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

Not applicable. There is no clinical test set requiring adjudication in this context.

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 is not an AI device, and no MRMC study was conducted or referenced. The device is a cortical electrode, a physical medical instrument.

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

Not applicable. This is not an algorithm or AI device. The testing described focuses on the physical and electrical characteristics of the electrode.

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

The "ground truth" for this device's evaluation is primarily based on:

• Engineering specifications and standards: Conformance to pre-defined physical dimensions, electrical properties (IEC 60601), and material properties.
• Biocompatibility standards: Conformance to ISO 10993-1 and ASTM F756.
• Predicate device characteristics: The NeuroOne Cortical Electrode is deemed substantially equivalent if its performance aligns with that of the legally marketed predicate device (PMT Subdural Cortical Electrode) in terms of intended use, indications for use, technological characteristics, and safety profile, such that any differences do not raise new questions of safety or efficacy.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

Not applicable. As there is no training set, there is no establishment of ground truth for one.

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The °AirRay® Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (

The ° AirRay® Subdural Cortical Electrodes Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.

The provided text is a 510(k) summary for the CorTec AirRay Subdural Cortical Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information regarding acceptance criteria, a test set, ground truth establishment for a test set, expert involvement, and comparative effectiveness studies is not present in this document, as these are typically part of a different type of submission (e.g., a PMA or De Novo) or a more detailed clinical study report, which is not included here.

However, the document does contain information about biocompatibility testing, which does have acceptance criteria for physical and chemical characteristics, and the results of those tests. I will focus on that section for the table, as it is the only part that directly addresses acceptance criteria and performance against them.

Here's a breakdown of what can be extracted and what is not available:

1. Table of acceptance criteria and the reported device performance:

The document provides a "Biocompatibility Summary Table" with test methods, results, and conclusions. The acceptance criteria are implicitly "Pass" for each test, indicating that the device's performance met the required biological safety standards.

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

• Sample Size: The document mentions that "All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP), 21 CFR Part 58." While specific numbers for each test are not listed, the document states, for example, that the "4-week brain implantation study was conducted in rabbits" and "Both male and female animals were used." This implies a typical sample size used in GLP studies for animal testing, which adheres to specific guidelines for statistical significance (though exact numbers are often not in a 510(k) summary).
• Data Provenance: The studies were conducted on the "finished, sterilized device." The location of the studies (e.g., country) is not explicitly stated beyond the submitter's location in Germany. These are prospective tests performed specifically for this submission.

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

• Biocompatibility Ground Truth: For the implantation study, it is stated that "The macroscopic and microscopic evaluations were performed by a board certified veterinary pathologist." This pathologist served as the expert for establishing the "truth" (i.e., the presence or absence of adverse tissue reactions) in that specific test. For other biocompatibility tests (cytotoxicity, sensitization, etc.), these are standardized laboratory assays with defined pass/fail criteria, so the "ground truth" is established by the assay's results per validated protocols, interpreted by qualified lab personnel.
• For human clinical performance (not applicable to this 510(k) summary): No information is provided as this is a device clearance based on substantial equivalence and non-clinical testing.

4. Adjudication method for the test set:

• For the biocompatibility studies, standard GLP practices and validated test protocols are followed. Results are typically reviewed and signed off by the study director and relevant subject matter experts (e.g., the veterinary pathologist). There's no "adjudication" in the sense of multiple human readers disagreeing on clinical image interpretation, as this is laboratory testing.

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 device is a passive implant (subdural cortical electrodes) and is not an AI-powered diagnostic device. Therefore, a MRMC study of human reader performance with or without AI assistance is not applicable and was not conducted.

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

• No. This device does not have an algorithm or software component that operates in a standalone capacity. It is a physical medical device. The document explicitly states "Contains Software/Firmware: No".

7. The type of ground truth used:

• For the biocompatibility studies, the ground truth was laboratory test results and expert pathological evaluation (specifically for the implantation study). This is empirical data derived from standardized biological and chemical tests.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML device that requires a training set. The clearance is based on substantial equivalence to a predicate device and non-clinical performance testing.

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

• Not applicable. As a non-AI/ML device, there is no training set and therefore no ground truth established for one.

In summary, the provided document focuses on the physical and biological safety of the device through non-clinical testing, particularly biocompatibility. It is a substantial equivalence submission, comparing the new device to an existing predicate rather than demonstrating clinical efficacy through a structured clinical study with human patients and expert review of clinical outcomes/interpretations.

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