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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 (< 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 recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

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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The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Maero Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Depth 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 nerve tissue (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 describes a 510(k) premarket notification for AD-TECH Depth Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, experts, and comparative effectiveness studies is not applicable to this type of submission.

Here's a breakdown of the relevant and non-applicable points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This submission is for demonstrating substantial equivalence based on technological characteristics and intended use, not for reporting performance against predefined acceptance criteria from a specific study for a novel device. The conclusion states: "The characteristics of the Depth Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

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

Not Applicable. There is no specified "test set" or data from a performance study mentioned in this 510(k) summary. The submission relies on demonstrating similarity to existing, legally marketed predicate devices.

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

Not Applicable. No ground truth establishment for a test set is discussed.

4. Adjudication Method for the Test Set

Not Applicable. No adjudication method for a test set is discussed.

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

Not Applicable. No MRMC study was conducted or mentioned. The submission is not focused on demonstrating improved human reader performance with or without AI assistance, as it pertains to medical devices (depth electrodes) rather than AI-driven diagnostic tools.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is hardware (depth electrodes), not an algorithm or software. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

Not Applicable. No ground truth is discussed as this is not a diagnostic device requiring comparison to a definitive truth. The "ground truth" in 510(k) submissions for devices like this typically relates to established clinical use and safety of predicate devices.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary of what the submission does present:

The submission focuses on establishing substantial equivalence to predicate depth electrodes by comparing their intended use and technological characteristics.

• Intended Use: The AD-TECH Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for recording, monitoring, and stimulating electrical signals at the subsurface level of the brain, aiding in defining epileptogenic foci and brain mapping. This intended use is compared to the predicate devices.
• Technological Characteristics: The submission explicitly states, "The technical characteristics of the depth electrodes are not affected this submission," implying that the characteristics of the new electrodes are sufficiently similar to the predicate devices and thus do not raise new questions of safety or effectiveness. From the context, this suggests the new electrodes inherit similar design, materials, and function as the specified predicate devices.

The "study" proving the device meets the acceptance criteria (in this context, substantial equivalence criteria) is the 510(k) premarket notification process itself, where the manufacturer provides documentation to the FDA demonstrating that the new device is as safe and effective as a legally marketed predicate device. The FDA's review and subsequent letter of substantial equivalence (K053358) serve as the "proof" that the device meets the regulatory requirements for market entry.

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The Macro-Micro Depth Electrodes are intended for use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Depth 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 nerve tissue. 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 depth electrodes. The main components of the depth electrodes are: 1. Contract strip with macro depth electrode contacts and connector contacts; 2. Stylet; Inner lumen: 3. 4. Micro wire electrode(s) for insertion and placement through the macro electrode inner lumen. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The materials are the same as used in the predicate devices and/or are common to depth electrodes.

The provided text is a 510(k) premarket notification for a medical device called "Macro-Micro Depth Electrodes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically seen for novel devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided document.

Instead, the document highlights:

• Substantial Equivalence: The primary assertion is that the Macro-Micro Depth Electrodes are "substantially equivalent" to predicate devices (K891920, K964644 from AD-TECH Medical Instrument Corporation and K033173 from Fhc, Inc.). This means the device has the same intended use and similar technological characteristics, and "no new questions of safety or effectiveness are raised."
• Technological Characteristics: The document lists the components (contact strip, stylet, inner lumen, micro wire electrode) and states that the materials are the "same as used in the predicate devices and/or are common to depth electrodes."
• Intended Use: The device is for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain."

In summary, there is no detailed study or acceptance criteria reported within this 510(k) summary because the approval mechanism relies on demonstrating equivalence to already approved devices, not on proving efficacy through new clinical trials against specific performance benchmarks.

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The foramen ovale electrode is designed for monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy. The foramen ovale electrode is intended for "Surgical Use Only" and "Not Intended for Implantation" This product should only be used by a physician/surgeon trained in the use of foramen ovate electrodes.

Ad-Tech's Foramen Ovale Electrode has similar intended uses, naterials, technological characteristics, sterilization procedures, and packaging as the commercially available Ad-Tech Depth Electrode (K 891920B). The Foramen Ovale Electrodes are used for intraoperative monitoring ( for surgical use only / not for implantation) and recording of electrical brain signals for epilepsy monitoring on the surface and sub-surface of the brain.

The provided text is a Summary of Safety and Effectiveness for the Ad-Tech's Foramen Ovale Electrode, submitted as part of a 510(k) premarket notification to the FDA.

Based on the provided document, the device did NOT undergo a study to demonstrate performance against specific acceptance criteria.

This document describes a "substantial equivalence" determination, which is a regulatory pathway where a new device is compared to a legally marketed predicate device rather than undergoing a de novo clinical study to establish its own performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in this type of regulatory submission. The information provided focuses on demonstrating that the new device is essentially the same as an existing, approved device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:

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

• Acceptance Criteria: Not explicitly stated or defined. The basis for acceptance is "substantial equivalence" to a predicate device.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, impedance) are reported for this specific device. The document states that the device has "similar intended uses, materials, technological characteristics, sterilization procedures, and packaging" as the predicate device.

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

• Sample Size for Test Set: Not applicable / Not provided. No test set was used for a performance study.
• Data Provenance: Not applicable. No new data from a performance study is described.

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)

• Number of Experts: Not applicable / Not provided. No ground truth was established for a test set for performance evaluation.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable / None 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

• MRMC Study: No. This device is an electrode for recording brain signals, not an AI-powered diagnostic tool, and no such study is mentioned or relevant to this type of device.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance Study: No. This device is an electrode, not an algorithm.

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

• Type of Ground Truth: Not applicable. No ground truth for performance evaluation was established for this device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not provided. This document describes a medical device, not a machine learning model that requires a training set.

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

• How Ground Truth was Established for Training Set: Not applicable.

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The use of the Model CMU Cortical Mapping Unit is indicated where intraoperative, short-term recording of cortical surface EEG activity is required.

AD-TECH's Model CMU Cortical Mapping Unit has similar intended uses, materials and technological characteristics as the predicate device. There are only three differences of note:
(1) Our electrode plates are made of clear Lexan plastic while theirs are stainless steel. We maintain that the clear plates are a marketing feature.
(2) Our electrodes are made of stainless steel; theirs use cotton wicks.
(3) Our device is sterilized via EtO: theirs may be autoclaved.

This 510(k) summary describes a device called the "Model CMU Cortical Mapping Unit" and compares it to a predicate device, the "Model CE-1 Cortical Electrode" (Grass Instruments). The summary explicitly states that the new device is an "enhanced version of a pre-amendment device" and has "similar intended uses, materials and technological characteristics as the predicate device." Crucially, it then states: "None of these difference are material to the safety & effectiveness of the device."

The document does not include a study with acceptance criteria and reported device performance in the traditional sense for demonstrating a new algorithm's efficacy. Instead, it relies on demonstrating substantial equivalence to a legally marketed pre-amendment device. Therefore, many of the requested fields about study design and performance metrics are not applicable in this context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission hinges on demonstrating substantial equivalence to a predicate device, not on meeting specific, quantified performance acceptance criteria through a new study. The "performance" is implicitly deemed equivalent to the predicate device.

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

Not applicable. No new performance study on a test set (with a specific sample size) was conducted or reported.

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

Not applicable. No new test set with ground truth established by experts was used.

4. Adjudication Method for the Test Set

Not applicable.

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 not an AI-assisted diagnostic tool and no MRMC study was conducted.

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

Not applicable. This device is a hardware unit for recording EEG potentials, not an algorithm.

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

Not applicable. The basis for approval is substantial equivalence to a pre-amendment device, not a new ground truth study.

8. The sample size for the training set

Not applicable. This device is a hardware unit, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary of Device Equivalence (as detailed in the 510(k) Summary):

The submission argues for substantial equivalence based on the following:

Key Takeaway from the FDA Letter:

The FDA's letter (K992194) confirms their agreement with AD-TECH's assessment of substantial equivalence to the predicate device. It states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates that the regulatory pathway chosen (510(k)) relies on demonstrating similarity to an already approved device rather than presenting a novel performance study against defined acceptance criteria.

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Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

The Ad-Tech Spinal Electrode addressed in this premarket notification has identical materials, technological characteristics, sterilization procedures and packaging as the commercially available Ad-Tech Depth Electrode (K891920B). The device has similar intended use, materials and technological characteristics to the commercially available Nicolet Epidural Spinal Electrode (K882053). Like this device, the Ad-Tech Spinal Electrode is to be placed epidurally for monitoring evoked potentials.

The provided 510(k) summary for the Ad-Tech's Spinal Electrode does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Nicolet Epidural Spinal Electrode K882053) based on:

• Identical materials, technological characteristics, sterilization procedures, and packaging to a commercially available Ad-Tech Depth Electrode (K891920B).
• Similar intended use, materials, and technological characteristics to the Nicolet Epidural Spinal Electrode.

The document states: "Ad-Tech believes that the information provided in this premarket notification clearly demonstrate that it is safe and equivalent to the mentioned commercially marketed predicate device." This implies that the 'acceptance criteria' for this 510(k) submission was substantial equivalence, not specific performance metrics demonstrated through a detailed study on the new device.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission relies on equivalence.
2. Sample size used for the test set and the data provenance: Not applicable, no specific test set or study is described for the new device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission is for a medical device that established substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria for a new, innovative technology.

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