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.

Device Description

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.

AI/ML Overview

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

Hazard Addressed	Test Method Used	Acceptance Criterion	Medical Device Configuration Tested	Summary of Test Results and pass/fail (if Appropriate)
Image Artifact (1.5T)	ASTM F2119-13	No Criteria, Descriptive Statement	Device with the maximum mass/linear length	Adoption from 3.0T tests since 3.0T is the worst-case.
Magnetically Induced Displacement Force (1.5T)	ASTM F2052-15	<45° deflection	The device with maximum mass	Adoption from 3.0T tests since 3.0T is the worst-case.
Magnetically Induced Torque (1.5T)	ASTM F2213-17, Low friction surface method	<45° rotation	The device with maximum mass	Adoption from 3.0T tests since 3.0T is the worst-case.
RF Induced Heating (1.5T)	ASTM F2182-19e2	<6°C	Based on ISO10974 methodology; devices with different lengths, electrode designs, and insertion depths.	Under the condition defined in the labeling, the MR induced heating will be less than <6°C
Image artifact (3.0T)	ASTM F2119-13	No Criteria, Descriptive Statement	Device with the maximum mass/linear length	Image distortion of 19 mm from the edge of the device
Magnetically Induced Displacement Force (3.0T)	ASTM F2052-15	<45° deflection	The device with maximum mass	pass
Magnetically Induced Torque (3.0T)	ASTM F2213-17, Low friction surface method	<45° rotation	The device with maximum mass	pass
RF Induced Heating (3.0T)	ASTM F2182-19e2	<6°C	Based on ISO10974 methodology; devices with different lengths, electrode designs, and insertion depths.	Under the condition defined in the labeling, the MR induced heating will be less than <6°C

The following information, as requested in your prompt, is not applicable or not available in the provided text because the document is not about an AI/software device:

Sample size used for the test set and the data provenance: Not applicable. This is not a study on an algorithm's performance on a dataset of patient data. It is testing on physical device configurations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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May 18, 2023

Ad-Tech Medical Instrument Corporation % Linford Leitch Regulatory Consultant NAMSA Medical Research Organization 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K223276

Trade/Device Name: Anchor Bolts as Accessories to Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: April 17, 2023 Received: April 18, 2023

Dear Linford Leitch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

Patrick Antkowiak Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223276

Device Name

Anchor Bolts as Accessories to Depth Electrodes

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5 510(k) Summary

Company Name, Address: a. Ad-Tech Medical Instrument Corporation 400 West Oakview Parkway Oak Creek, WI 53154

b. Contact:

Brendan McCrea Chief Technology Officer 400 West Oakview Parkway Oak Creek, WI 53154 Email: bmccrea@adtechmedical.com Phone: (262) 634-1555 x1100

c. Official Correspondent: Linford Leitch Regulatory Consultant NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
d. Date prepared October 21, 2022
e. Subject Device Device Name: Device Classification Name: Regulation Number: Common Name: Device Class: Classification Product Code: GZL Regulation Medical Specialty: 510(k) Review Panel:

Anchor Bolts Electrode, Depth 21 CFR Anchor Bolt (Accessory to Depth Electrode) Class II Neurology Neurology

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Predicate Device f.

The Anchor Bolt is substantially equivalent to:

510(k) Number:	K181544
Device Name:	Anchor Bolt
Applicant:	Ad-Tech Medical Instrument Corporation
Device Classification Name:	Electrode, Depth
Regulation Number:	21 CFR 882.1330
Common Name:	Anchor Bolt (Accessory to Depth Electrode)
Device Class:	Class II
Classification Product Code:	GZL
Regulation Medical Specialty:	Neurology
510(k) Review Panel:	Neurology

g. Device Description

h. Intended Use / Indications for Use
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.
i. Statement of Substantial Equivalence Table 1: Comparison Anchor Bolts - Features of the Anchor Bolts are detailed below:
j. Comparison Table

Table 1: Comparison Anchor Bolts

Feature	Anchor Bolts(Under Review)	Anchor BoltsK181544	Comment
Indications for Use	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 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.	Same
Clinical Application	Threaded into a pre-drilled hole in the skull.	Threaded into a pre-drilled hole in the skull.	Same
Duration of use	< 30 days	< 30 days

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Feature	Anchor Bolts(Under Review)	Anchor BoltsK181544	Comment
Contraindications	Anchor Bolts should not be usedon any patient whom thephysician/ surgeon considers atrisk for infection or on whom theuse cannot be performed safely.The Anchor Bolt should not beused with patients that havesoftening of the skull or low skullbone density.	Anchor Bolts should not be usedon any patient whom thephysician/ surgeon considers atrisk for infection or on whom theuse cannot be performed safely.The Anchor Bolt should not be usedwith patients that have softening ofthe skull or low skull bone density.	Same
Anchor Bolt Singlepatient use,DisposableProvided Sterile	Yes (Anchor Bolts providedsterile, optional forPlacement/Removal Wrench )	Yes (Anchor Bolts provided sterile,optional for Placement/RemovalWrench)	Same
User Sterilizable	Yes (Placement/Removal Wrenchonly)	Yes (Placement/Removal Wrenchonly)	Same
Environment of Use	Intraoperative andNeurological monitoringlocations	Intraoperative and Neurologicalmonitoring locations	Same
Duration of Use	< 30 days	< 30 days	Same
Patient contactmaterial	TitaniumSilicone (innerlumen gasket) Parylene	TitaniumSilicone (inner lumengasket) Parylene	Same
Length	13 mm to 26 mm	13 mm to 26 mm	Same
Compatible DepthElectrode BodyDiameter	0.86 mm to 1.3 mm	0.86 mm to 1.3 mm	Same
Depth ElectrodeRetention Force	> 100 grams	> 100 grams	Same
Placement / RemovalWrench	Yes	Yes	Same
MR Labeling	MR Conditional	Safety in MRI Not Evaluated	SubstantiallyEquivalent
MR Labeling does not raise any questions of the safety and effectiveness of the device because performance

testing was completed to evaluate MR conditional parameters. The Anchor Bolts labeling has been updated with MR Conditional use information.

k. Performance Data

Ad-Tech, in conjunction with University of Houston, has conducted performance evaluations of the Anchor Bolts to address hazards in the MR environment. As per the Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, issued May 20, 2021, for passive devices, evaluations were conducted for image artifact, magnetically induced displacement force, magnetically induced torque and RF induced heating. Results of the testing allow the device to be labeled MR Conditional and the results summaries follow.

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Hazard Addressed	Test Method Used	AcceptanceCriterion	Medical DeviceConfiguration Tested	Summary of TestResults and pass/failif Appropriate
Image Artifact	ASTM F2119-13	No Criteria,DescriptiveStatement	Device with themaximum mass/linearlength	Adoption from 3.0Ttests since 3.0T is theworst-case.
Magnetically Induceddisplacement force	ASTM F2052-15	<45° deflection	The device withmaximum mass	Adoption from 3.0Ttests since 3.0T is theworst-case.
Magnetically InducedTorque	ASTM F2213-17,Low friction surfacemethod	<45° rotation	The device withmaximum mass	Adoption from 3.0Ttests since 3.0T is theworst-case.
RF Induced Heating	ASTM F2182-19e2	<6°C	Based on theISO10974methodology anddevices with differentlengths, differentelectrode designs, anddifferent insertiondepths were studied.	Under the conditiondefined in thelabeling, the MRinduced heating willbe less than <6°C

Table 2: 1.5T Test Result Summary

Table 3: 3.0T Test Result Summary

Hazard Addressed	Test Method Used	AcceptanceCriterion	Medical DeviceConfiguration Tested	Summary of TestResults and pass/fail ifAppropriate
Image artifact	ASTM F2119-13	No Criteria,DescriptiveStatement	Device with themaximum mass/linearlength	Image distortion of 19mm from the edge of thedevice
Magnetically InducedDisplacement Force	ASTM F2052-15	<45° deflection	The device withmaximum mass	pass
Magnetically InducedTorque	ASTM F2213-17,Low friction surfacemethod	<45° rotation	The device withmaximum mass	pass
RF Induced Heating	ASTM F2182-19e2	<6°C	Based on theISO10974methodology anddevices with differentlengths, differentelectrode designs, anddifferent insertiondepths were studied	Under the conditiondefined in the labeling,the MR induced heatingwill be less than <6°C

l. Conclusion

The Anchor Bolts meet performance requirements equivalent to the predicate device. The intended use and technology of the Anchor Bolts are the same as the predicate device.

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).