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The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes.

The furnished document is an FDA 510(k) Premarket Notification stating substantial equivalence for the "Anchor Bolts as Accessories to Depth Electrodes" device. It outlines the device description, intended use, comparison with a predicate device, and performance data related to its safety in the Magnetic Resonance (MR) environment.

However, the information provided does not describe an AI medical device or a study involving human readers or AI assistance. The performance data is solely for the physical device's safety in an MR environment, not for an AI algorithm's diagnostic or assistive performance.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies for an AI medical device, multi-reader multi-case studies, or AI algorithm performance.

The document discusses the following acceptance criteria and performance for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

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The AD-TECH Depth Electrodes (Spencer Probe Depth Electrodes) are intended for temporary (

The Depth Electrodes (Spencer Probe Depth Electrode) are intended for recording, monitoring and stimulation at sub-surface levels of the brain. These electrodes are provided sterile, disposable and single patient use. The Depth Electrodes (Spencer Probe Depth Electrodes) provide the patient contact device. The Depth Electrodes (Spencer Probe Depth Electrodes) connect to an electrode cable that is applied to the user's equipment. The electrodes are used by physicians.

Here's a breakdown of the acceptance criteria and the study information for the Spencer Probe Depth Electrodes, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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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 Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode.

Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes.

The provided text describes the 510(k) premarket notification for "Anchor Bolts as Accessories to Depth Electrodes." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not describe a software-as-a-medical-device (SaMD) or AI/ML-based device that would require the kind of complex clinical study with human readers and ground truth adjudication methods typically seen for such applications.

Therefore, many of the requested criteria, such as expert opinions, MRMC studies, standalone algorithm performance, and training set information, are not applicable or mentioned in this type of submission. The information provided is for a physical medical device.

However, I can extract the relevant "acceptance criteria" (performance requirements for the device) and the "study" (non-clinical performance tests) that prove the device meets these criteria.

Device Name: Anchor Bolts as Accessories to Depth Electrodes

Device Type: Physical Medical Device (Accessory to Depth Electrodes)

Study Focus: Non-clinical performance tests to demonstrate substantial equivalence to a predicate device.

Here's the information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: For the mechanical performance tests (Torque, Axial tension, CSF leakage), a sample size of N=10 was generally used. For the CSF leakage test, N=22 samples were used. Other tests like sterility, sterile barrier integrity, shelf life, and biocompatibility applied broader methods/principles to the devices.
• Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Ad-Tech Medical Instrument Corporation. The document does not specify the country of origin for the data beyond the company's address in Oak Creek, WI, USA. This is retrospective data from device testing.

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

• Not Applicable. This submission is for a physical medical device and relies on engineering and material science testing methods (e.g., tensile testers, torque wrenches, established biocompatibility protocols) rather than human expert interpretation of medical images or clinical outcomes. Therefore, no "medical experts" in the sense of radiologists or similar were used to establish ground truth for these non-clinical performance tests.

4. Adjudication Method for the Test Set:

• None. As the tests are non-clinical, objective measurements, there is no human interpretation or "adjudication" required in the way it would be for a diagnostic AI. The results are quantitative and pass/fail based on pre-defined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not a diagnostic imaging device or an AI/ML-based device. Thus, MRMC studies are not relevant to demonstrating the safety and effectiveness of an anchor bolt for depth electrodes.

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

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance tests is based on objective, quantitative measurements against defined engineering specifications and industry standards for mechanical performance, sterility, and biocompatibility. For instance, the "ground truth" for axial tension is the measured force in lbf, compared to a ≥ 40 lbf requirement. The "skull bone" simulation was polyurethane foam (40 pcf).

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set."

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The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.

The device under review is a family of cranial drill bits and accessories. These cranial drill bits and accessories are applied to create a hole through the skull in support of neurological procedures. Cranial drill bits are twist drill bits used for drilling holes in the skull, supporting access to the brain for brain biopsy, brain contacting electrode placement, electrode accessory placement such as Anchor Bolts or other needs as determined by the user. The cranial drill bit variations are 16 cm to 30 cm length and 2.4 mm to 3.2 mm outer diameter. Accessories to the cranial drill bits include: Drill Stop, Drill Stop Wrench, Drill Sleeve Guide, Guide Block.

The provided document is a 510(k) summary for Ad-Tech Medical Instrument Corporation's Cranial Drill Bits and Accessories. It outlines the device's indications for use, technological characteristics, and performance tests for demonstrating substantial equivalence to predicate devices. This document does not pertain to an AI/ML powered medical device, an autonomous AI device, or other medical device software. Therefore, the questions regarding acceptance criteria and studies for AI-powered devices are not applicable.

Here's an analysis of the provided information, addressing the closest relevant aspects:

Acceptance Criteria and Device Performance for (Non-AI) Cranial Drill Bits and Accessories

The acceptance criteria are not explicitly titled as "acceptance criteria" but are embedded within the "Summary of Requirement" for the performance tests conducted. The device performance is reported as "Pass" for all listed tests.

1. Table of Acceptance Criteria and Reported Device Performance

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The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (

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

This document describes the Ad-Tech Medical Instrument Corporation's Depth Electrodes (K163355) and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this 510(k) summary for a traditional medical device.

However, I can extract the acceptance criteria (defined as "Summary of Requirement" in the document) and the reported performance ("Result") for the physical device testing.

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

The following information is not applicable to this document as it pertains to an AI/ML software device, and this 510(k) is for a set of physical medical electrodes:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Additional relevant information from the document:

• Intended Use: The Ad-Tech Depth Electrodes are intended for temporary (

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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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The DNAP Cranial Nerve Electrodes are designed for intraoperative monitoring/recording for less than or equal to 10 hours from the cochlear cranial nerves during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

The DNAP Cranial Nerve Electrode (DNAP electrode) is intended for intraoperative nerve monitoring/recording during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle during surgical procedures. The DNAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System MEE-1000A or MEE-2000 Neural Function Measuring System.

The DNAP electrode is a single patient use, disposable cranial nerve electrode used for recording cranial nerve action potentials. The DNAP electrode may be used for recording the action potentials of cochlear nucleus elicited by auditory stimulation. The user places the electrode on the dorsal cochlear nuclei. Access to the dorsal cochlear nuclei may be through the foremen of Luschka. This potential is called DNAP (dorsal cochlear nucleus action potential), and used to preserve cochlear nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle.

The provided document is a 510(k) summary for the Ad-Tech Medical Instrument Corporation's DNAP Cranial Nerve Electrode. It outlines the device's indications for use and compares its technological characteristics and performance to a predicate device (Cueva Cranial Nerve Electrode K044061) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not specify the exact sample size for the test sets used in the performance benches. It refers to "evaluations" and "tests" without detailing the number of devices or trials.
   • Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). Given these are bench tests for a medical device seeking premarket notification in the US, it's highly likely they were conducted in a controlled lab environment.

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

   • This question is not applicable to the type of studies presented. The performance tests (electrical resistance, tensile strength, compatibility, biocompatibility) are objective bench tests, not requiring expert human interpretation or "ground truth" establishment in the clinical sense.

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

   • This question is not applicable as the studies described are objective bench tests, not involving subjective human assessment or consensus methods for ground truth adjudication.

4. 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. This device is an electrode for intraoperative monitoring, not an AI-powered diagnostic tool that assists human readers/interpreters. The focus is on the physical and electrical performance of the electrode itself.

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

   • No, a standalone algorithm performance study was not done. This device is a physical medical instrument (an electrode), not an algorithm or software. Its function is to record signals, which are then interpreted by human clinicians using an external Neural Function Measuring System.

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

   • The "ground truth" for the performance tests consists of objective, predefined engineering and biocompatibility standards and specifications. For instance, electrical resistance must fall within a specified range, and tensile strength must meet a certain threshold without failure.

7. The sample size for the training set:

   • This is not applicable. The device is an electrode, not a machine learning model. Therefore, there is no "training set."

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

   • This is not applicable as there is no training set for this type of device.

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The Brain Biopsy Needles are used during guided procedures and by methods deemed safe by the physician/surgeon to remove a targeted tissue for biopsy.

Brain Biopsy Needles are used to remove a targeted sample of brain tissue for analysis. These Brain Biopsy Needles are side-cutting needles. Side-cutting needles can extract several tissue samples without requiring a new trajectory.

Biopsy needles are used to sample brain tissue or to extract brain tissue samples to determine tissue abnormality or any deviation from healthy brain tissue. These Brain Biopsy Needles substantially consist of two cannulae that fit inside one another. Both cannulas have a sampling window opening in the distal tip. The inner cannula window opening has a sharp edge. The Brain Biopsy Needle is placed into tissue to the desired depth. An aspiration syringe may be attached to the brain biopsy to support aspiration of a small amount of tissue into the sampling window. The inner cannula is rotated such that the sampling window removes a tissue sample. The inner cannula is removed. The tissue sample from the inner cannula is removed for analysis. The inner cannula may be passed back through the outer cannula and additional biopsies can be taken as directed by the surgeon.

This document describes the Ad-Tech Medical Instruments Corporation's Brain Biopsy Needle and its 510(k) summary for MRI Conditional labeling.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission (K112094), the acceptance criteria and reported device performance are related to the MRI Compatibility of a specific variation of the Brain Biopsy Needle.

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

The document does not specify a "test set" in the traditional sense of a clinical or observational study with a certain number of patient cases or samples. Instead, the testing relates to the physical device's interaction with MRI environments.

• Sample Size: The testing was performed on the Model MDBM-08-28 Brain Biopsy Needle variation. The document does not specify a number of individual units of this variation that were tested, but rather refers to "MRI modeling and MRI testing."
• Data Provenance: The testing was conducted by or for Ad-Tech Medical Instruments Corporation. The document does not specify country of origin for the data or whether it was retrospective or prospective, as it pertains to engineering/device characterization rather than clinical data.

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

Not applicable. This submission concerns the physical characteristics and safety of a medical device in an MRI environment, not diagnostic accuracy requiring expert interpretation for ground truth. The "ground truth" here is established by engineering standards and validated MRI testing protocols.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication of findings.

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 device is a biopsy needle, not an AI-powered diagnostic tool. The submission is for a 510(k) premarket notification for an MRI-conditional label, not an AI/CAD device.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating MRI compatibility was based on established engineering principles, MRI safety standards, and validated testing protocols (e.g., for magnetic field interactions, RF heating, and image artifact assessment). The document specifically mentions "MR modeling and MRI testing."

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/Machine Learning algorithm that requires a training set.

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

Not applicable. There was no training set for this device.

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The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (

Subdural electrodes described in this application are single patient use, disposable, sterile and non-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 physician.

The provided text is a 510(k) summary for AD-TECH Subdural Electrodes. It describes the device, its intended use, and states that its technological characteristics are substantially equivalent to predicate devices.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices, which is a different regulatory pathway than providing performance data against defined acceptance criteria. This type of submission typically relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot populate the requested table and information based on the provided text.

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