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 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:

Test (Acceptance Criteria)	Reported Device Performance (Result)
Torque required to insert to pre-drilled skull hole:	Pass: All results ≤ 1 in-lbs. (Acceptance Criteria: ≤ 8 in-lbs.)
Axial tension to pull Anchor Bolt out of pre-drilled skull hole:	Pass: All results > 48 lbf. (Acceptance Criteria: ≥ 40 lbf.)
Axial tension to pull Depth Electrode from the Anchor Bolt:	Pass: All results > 140 grams. (Acceptance Criteria: ≥ 100 grams.)
Anchor Bolt gasket resist CSF leakage:	Pass: No leaks observed after 24 hours. (Acceptance Criteria: No leakage at the Depth Electrode, Anchor Bolt after 24 hours, under 15 mmHg hydrostatic pressure.)
Sterility:	Pass: Terminally ethylene oxide sterilized devices by a validated EtO sterilization cycle, per ANSI/AAMI/ISO 11135-1:2007 half-cycle method. The sterility assurance level (SAL) is ≤ SAL of 10-6.
Sterile barrier integrity:	Pass: Evaluated by simulated distribution, seal peel, and bubble emission testing for the double Tyvek pouch after terminal sterilization.
Anchor Bolt silicone gasket shelf life:	Pass: The same acceptance criteria were met. (Ability of real-time aged Anchor Bolts with Silicone Gaskets to meet Depth Electrode retention requirements and minimize cerebrospinal fluid (CSF) leakage were evaluated to the methods used for Axial tension to pull Depth Electrode from the Anchor Bolt and Anchor Bolt gasket resist CSF leakage.)
Biocompatibility:	Pass: Following test methods applied to final finished form Anchor Bolts (patient contacting materials), with passing results: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Genotoxicity (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Mouse Lymphoma Mutagenesis Assay), Hemocompatibility, Neurotoxicity, Subacute/Subchronic Toxicity, Implantation (Neurological (Brain) Implantation Test).

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."

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, which features a stylized depiction of human profiles. To the right of this symbol, there is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. The text is arranged in two lines, with 'U.S. FOOD & DRUG' on the top line and 'ADMINISTRATION' on the bottom line.

August 9, 2018

Ad-Tech Medical Instrument Corporation Gary Syring Principal Consultant Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K181544

Trade/Device Name: Anchor bolt (as an accessory to Depth Electrodes) Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: June 8, 2018 Received: June 12, 2018

Dear Mr. Syring:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jay R. Gupta -S

For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181544

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5.0 510(k) Summary

This summary is provided to support the 510(k) pre-market notification for the Anchor Bolts, as accessories to Depth Electrodes.

Company Name:	Ad-Tech Medical Instrument Corporation400 West Oakview ParkwayOak Creek, WI 53154Phone: (262) 634-1555
Company Contact:	Lisa Theama, Chief Operating Officer
Date Summary Prepared:	June 8, 2018
Trade Name:	Anchor Bolts
Common Name:	Anchor Bolt (Accessory to Depth Electrodes)
Classification Name:	Depth Electrode21 CFR 882.1330Product Code: GZLClass II
Predicate Device:	K970418 Anchor Bolt, Accessory Depthalon® Depth ElectrodePMT Corporation

Product Description 5.1

5.2 Intended Use of the Device

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

5.3 Summary of Technological Characteristics

The following table provides a side-by-side comparison of the Anchor Bolts to the predicate device applied to support this pre-market notification.

{4}------------------------------------------------

Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature	Anchor Bolts(Under Review)	Anchor Bolt, AccessoryDepthalon® Depth Electrode(Predicate K970418)	Comment
Indicationsfor Use	The Ad-Tech Anchor Bolts areoptional accessories for use withDepth Electrodes. The Anchor Boltsmay be applied when it is desired tominimize concerns about potentialcerebrospinal fluid (CSF) leakage andinfection of the subdural space whilestabilizing the electrode.Anchor Bolts are secured in the skullto provide an access point for DepthElectrodes.	The PMT depth electrode anchorbolt is an accessory used in caseswhere it is necessary to minimizeconcerns about potentialcerebrospinal fluid leakage andinfection of the subdural space willstabilizing the electrode duringintraoperative electro clinicalcharacterization. The PMT depthelectrode anchor bolts rest on theskull with the insertion of theanchor bolt tapered screw threadsinto a predrilled burr hole througha skin incision.	Same.Both Anchor Boltsare applied to apre-drilled hole inthe skull. TheAnchor Boltssupport DepthElectrodeplacement.
ClinicalApplication	Threaded into a pre-drilled hole in theskull.	Threaded into a pre-drilled hole in theskull.	Same
Duration ofuse	< 30 days	< 30 days	Same
Contra-indications	Anchor Bolts should not be used onany patient whom the physician/surgeon considers at risk for infectionor on whom the use cannot beperformed safely.The Anchor Bolt should not be usedwith patients that have softening ofthe skull or low skull bone density.	Depthalon® Depth Electrodesshould not be used in the presenceof any infection of the scalp. Otherinfections may be considered acontraindication if determined bythe attending physician.The Anchor bolt accessory shouldnot be used if the patient has asoftening of the skull or low skullbone density.	EquivalentAnchor Bolts areselected andapplied by aphysicianknowledgeable intheir use.
Anchor BoltSingle patientuse,Disposable	Yes	Yes	Same
ProvidedSterile	Yes(Anchor Bolts provided sterile,optional for Placement/RemovalWrench )	Yes(Anchor bolts can be providedsterile or non-sterile)	Equivalent
UserSterilizable	Yes(Placement/Removal Wrench only)	Yes(Anchor Bolts supplied non-sterile)	As a convenienceto the user, thePlacement /Removal Wrenchcan be re-sterilized.
Environmentof Use	Intraoperative and Neurologicalmonitoring locations	Intraoperative and Neurologicalmonitoring locations	Same
Duration ofUse	< 30 days	< 30 days	Same
Patientcontactmaterial	TitaniumSilicone (inner lumen gasket)Parylene	Titanium AlloySilicone (inner lumen gasket)	Equivalent
Length	13 mm to 26 mm	25 mm to 40 mm	Equivalent
Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature	Anchor Bolts(Under Review)	Anchor Bolt, AccessoryDepthalon® Depth Electrode(Predicate K970418)	Comment
CompatibleDepthElectrodeBodyDiameter	0.86 mm to 1.3 mm	1.27 mm	Equivalent
DepthElectrodeRetentionForce	> 100 grams	> 100 grams	Same
Placement /RemovalWrench	Yes	Unknown	Given the uniquedesign of AnchorBolts it is verylikely that thepredicate devicerequires aplacement andremoval tool. Handtightening anAnchor Bolt into apre-drilled skullhole is notprobable.
			The length of theAnchor Bolt isbased upon needand userpreferences.

{5}------------------------------------------------

5.4 Non-clinical Performance Tests to Demonstrate Substantial Equivalency

To establish the technical equivalency of the Anchor Bolts, evaluations were conducted to confirm compliance with performance requirements, including:

Test	Test Method Summary	Result
Torque required to insertto pre-drilled skull hole.	With a torque wrench, verify the torque required to insertthe Anchor Bolt into pre-drilled hole in 40 pcf polyurethanefoam (simulated skull bone) with the Placement/RemovalWrench is ≤ 8 in-lbs. (N=10 samples).	PassAll results ≤1 in-lbs.
Axial tension to pullAnchor Bolt out of pre-drilled skull hole.	With a tensile tester, measure the axial tension to pull theAnchor Bolt out of a pre-drilled hole in 40 pcf polyurethanefoam is ≥ 40 lbf. (N=10 samples)	PassAll results> 48 lbf.
Axial tension to pullDepth Electrode from theAnchor Bolt.	With a tensile tester, measure the axial tension to pull aDepth Electrode from the Anchor Bolt, ≥ 100 grams. (N=10samples).	PassAll results> 140grams.
Anchor Bolt gasket resistCSF leakage.	Insert Depth Electrode into the Anchor Bolt secured in 40pcf polyurethane foam. Apply a metal tube with a diameterlarger than the Depth Electrode and Anchor Bolt body,around both. Seal the metal tube to the polyurethane foam.Fill the metal tube with water to a hydrostatic pressure of	PassNo leaksobserved
Test	Test Method Summary	Result
	15 mmHg. Verify no leakage at the Depth Electrode,Anchor Bolt after 24 hours. (N=22 samples)	after 24hours.
Sterility	Anchor Bolts and Placement/Removal Wrenches areterminally ethylene oxide sterilized devices by a validatedEtO sterilization cycle, per ANSI/AAMI/ISO 11135-1:2007half-cycle method. The sterility assurance level (SAL) is ≤SAL of 10-6.	Pass
Sterile barrier integrity	The sterile barrier package is a double Tyvek pouch. Themethods applied to evaluate the Tyvek sterile barrierpackage integrity included post terminal sterilization:simulated distribution, seal peel and bubble emissiontesting.	Pass
Anchor Bolt siliconegasket shelf life	The ability of real time aged Anchor Bolts with SiliconeGaskets to meet Depth Electrode retention requirementsand minimize cerebrospinal fluid (CSF) leakage wereevaluated to the methods above for Axial tension to pullDepth Electrode from the Anchor Bolt and Anchor Boltgasket resist CSF leakage.	PassThe sameacceptancecriteria weremet.
Biocompatibility	The following test methods were applied to final finishedform Anchor Bolts (patient contacting materials), withpassing results:Cytotoxicity: L929 MEM Elution Test – ISO Sensitization: Kligman Maximization Test - ISO Intracutaneous Reactivity: Intracutaneous Injection Test - ISO Acute Systemic Toxicity: 28-Day Systemic Toxicity in Rabbits via Subcutaneous Implantation Material-Mediated Pyrogenicity: Rabbit Pyrogen Test (Material Mediated) - ISO Genotoxicity: Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay - ISO and Mouse Lymphoma Mutagenesis Assay - ISO Hemocompatibility: Rabbit Blood Hemolysis Test (Indirect Contact) – ASTM Neurotoxicity by: SK-N-MC MEM Elution Test. Subacute / Subchronic Toxicity: Systemic Injection Test - ISO Implantation: Neurological (Brain) Implantation Test - ISO.	Pass

{6}------------------------------------------------

5.5 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).