The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

Device Description

The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.

The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.

AI/ML Overview

The provided document is a 510(k) summary for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing. It does not describe an acceptance criteria and study proving device meets acceptance criteria in the context of clinical performance or accuracy of an AI/ML device.

Therefore, I cannot extract the specifically requested information regarding acceptance criteria and study details as they pertain to such a device type because this information is not present in the provided document.

The document discusses:

Manufacturing and material equivalence: The new dilators are made of conductive silver ink, aluminum alloy, and dielectric coating and are compared to existing predicate devices.
Performance testing (non-clinical): This includes electrical safety testing (IEC 60601-1), functional performance testing (insulation effectiveness and electrical resistance), and reprocessing validation. All samples passed acceptance criteria for these tests.
Biocompatibility testing: Evaluated per ISO 10993-1 for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.

None of these tests involve "device performance" in terms of clinical accuracy, AI/ML output, or human-in-the-loop effectiveness.

However, I can extract the information that is present about the non-clinical performance testing:

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

Test	Acceptance Criteria	Reported Device Performance
Electrical Safety Testing and/or Evaluation	In accordance with IEC 60601-1: 2005(R)2012	All samples passed acceptance criteria
Functional Performance Testing and Verification	Not explicitly stated, but includes:	All samples passed acceptance criteria
- Insulation Effectiveness	- Meets functional requirements (implied by passing)
- Electrical Resistance	- Meets functional requirements (implied by passing)
Reprocessing	Cleaning validation or adoption study based on AAMI	All samples passed acceptance criteria
	TIR30:2011
	Steam sterilization validation or adoption performed
	per ANSI/AAMI/ISO 17665-1:2006/(R)2013

2. Sample size used for the test set and the data provenance: Not applicable. The tests mentioned are laboratory-based electrical, functional, and reprocessing tests, not clinical studies with patients or data sets with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and sterilization tests, not expert-adjudicated clinical assessments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical or image-based adjudication, not engineering tests.

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 an accessory instrument, not an AI/ML diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory instrument, not an AI/ML algorithm.

7. The type of ground truth used: Not applicable in the context of clinical accuracy or AI performance. For the engineering tests, "ground truth" would be the specifications and requirements of the applicable standards (e.g., IEC 60601-1, AAMI TIR30, ANSI/AAMI/ISO 17665-1).

8. The sample size for the training set: Not applicable. This device is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML product.

Summary

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September 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alphatec Spine, Inc. Sandy Gill Sr. Regulatory Affairs Specialist 1950 Camino Vido Roble Carlsbad, CA 92008

Re: K221821

Trade/Device Name: ATEC IOM Accessory Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: August 29, 2022 Received: August 30, 2022

Dear Sandy Gill:

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 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

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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 mediation-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.

for Jay Gupta 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) K221821

Device Name ATEC IOM Accessory Instruments

Indications for Use (Describe)

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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This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

I.	SUBMITTER:	Alphatec Spine, Inc.1950 Camino Vida RobleCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
	Contact Person:	Sandy GillSr. Regulatory Affairs Specialist
	Date Summary Prepared:	August 29, 2022

II. DEVICE

Trade or Proprietary Name:	ATEC IOM Accessory Instruments
Common Name:	Surgical nerve stimulator/locator
Classification Name:	Neurosurgical Nerve Locator
Regulation Number:	21 CFR 874.1820
Classification:	Class II
Product Code:	PDQ, ETN

III. LEGALLY MARKETED PREDICATE DEVICES

Primary Predicate Device:

510(k)	Product Name	Clearance Date
K191723	ATEC IOM Accessory Instruments	October 18, 2019

Additional Predicate Devices:

510(k)	Product Name	Clearance Date
K171807	ES2 Neuromonitoring Accessory Instruments	July 18, 2017
K110989	Neurovision Ink Printed Endotracheal TubeElectrode	November 03,2011
K212166	ISIS Headbox 5042XX and ISIS Neurostimulator	January 07, 2022

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Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a black line underneath the logo.

DEVICE DESCRIPTION IV.

The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.

V. INDICATIONS FOR USE

VI. TECHNOLOGICAL COMPARISON TO PREDICATES

The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. See Table 1 below.

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Table 1: Summary of Technological Comparison to Predicates
	Primary PredicateK191723	Additional PredicateK171807	Additional PredicateK110989	Additional PredicateK212166	Subject Device
Attribute	ATECIOM Instruments	Stryker ES2NeuromonitoringAccessoryInstruments	Neurovision InkPrinted EndotrachealTube Electrode	ISIS Headbox 5042XXand ISISNeurostimulator	ATECIOM Instruments
Indications forUse	The ATEC IOMAccessory Instrumentsare utilized in spinesurgical procedures toassist in location of thenerves during or afterpreparation andplacement of implants(intervertebral fusioncages and pedicle screwfixation devices) in openand percutaneousminimally invasiveapproaches.	The ES2 Neuromonitoringinstruments (Awls, Taps,Screwdriver and LITe Y-NEEDLE 200, 300 and400) can be used by thesurgeon to assist in locationof the spinal nerves byproviding proximityinformation before, duringor after bone preparationand placement of bonescrews in open andpercutaneous minimallyinvasive posterior surgicalapproaches of the non-cervical spine.	The Neurovision InkPrinted EndotrachealTube Electrode isintended for use duringsurgery and parasurgicalcare only, with anycompatible monitoringsystem, for continuousEMG monitoring andstatus assessment of thenerves supplying thelaryngeal musculature aswell as providing anopen airway for patientventilation.	ISIS Headbox 5042xxproducts:The products are intended forintraoperativeneuromonitoring; for recordingof electrophysiological signalsand stimulating of nerve andmuscle tissues. The productsare intended for use in theoperating room to measure anddisplay the electrical signalsgenerated by muscle,peripheral nerves and thecentral nervous system. Theproducts support the clinicalapplication ofElectroencephalography (EEG),Electromyography (EMG),Somatosensory EvokedPotentials (SEP), MotorEvoked Potentials (MEP), andAuditory Evoked Potentials(AEP). The products are notintended for monitoring life-sustaining functions.ISIS Neurostimulator 504180:The ISIS Neurostimulator isintended for provision ofneurophysiological stimulationwhen used in surgicalprocedures and for diagnostics.It is suitable for continuous	The ATEC IOMAccessory Instrumentsare utilized in spinesurgical procedures toassist in location of thenerves during or afterpreparation andplacement of implants(intervertebral fusioncages and pedicle screwfixation devices) in openand percutaneousminimally invasiveapproaches.
Attribute	Primary PredicateK191723	Additional PredicateK171807	Additional PredicateK110989	Additional PredicateK212166	Subject Device
	ATECIOM Instruments	Stryker ES2NeuromonitoringAccessoryInstruments	Neurovision InkPrinted EndotrachealTube Electrode	ISIS Headbox 5042XXand ISISNeurostimulator	ATECIOM Instruments
				the following fields:-Transcranialelectricalstimulation (TES) - Directcortical stimulation (DCS)-Direct nerve stimulation(DNS) - Transcutaneouselectrical nerve stimulation(TNS) — Direct musclestimulation (DMS)
RegulationNumber.Product Code, &Classification	21 CFR 874.1820PDQ, ETNClass II	21 CFR 874.1820PDQClass II	21 CFR 874.1820ETN, BTR, GWFClass II	21 CFR 882.1870GWF, ETN, GWE, GWJ,GWQ, IKN	21 CFR 874.1820PDQ, ETNClass II
IEC 60601Compliant	YesProtected Pin Design viacompatible clip/probeClause 56.3(c)	YesProtected Pin Design viacompatible clip/probeClause 56.3(c)	Unknown	Yes	YesProtected Pin Design viacompatible clip/probeClause 56.3(c)
Instrument Type(Description)	Drills/Taps. Awls.Probes, Screwdrivers,Dilators (Sleeves),Guidewires, and Needles	Awls, Taps, Screwdrivers,Guidewires (K-wires), and200, 300, 400 LITE Y-Needles	ET Tube	ISIS Xpert®Plus, ISISXpert®, ISISXpress Accessories	Drills/Taps. Awls.Probes, Screwdrivers,Dilators (Sleeves).Guidewires, and Needles
BiocompatibilityPatient ContactDuration	Limited patient durationcontact(< 24 hours)	Limited patient durationcontact(< 24 hours)	Limited patient durationcontact(< 24 hours)	Unknown	Limited patient durationcontact(< 24 hours)
Surgicalapproach	Open orPercutaneous/MinimallyInvasive	Open or Percutaneous/Minimally Invasive	Unknown	Unknown	Open orPercutaneous/MinimallyInvasive
Sterility	Sterile via EtO and non-sterileNon-sterile devices areprovided with validatedsteam sterilization	Sterile and Non-sterileNon-sterile devices areprovided with validatedsteam sterilization	Sterile	Unknown	Sterile via EtO and non-sterileNon-sterile devices areprovided with validatedsteam sterilization
Attribute	Primary PredicateK191723	Additional PredicateK171807	Additional PredicateK110989	Additional PredicateK212166	Subject Device
	ATECIOM Instruments	Stryker ES2NeuromonitoringAccessoryInstruments	Neurovision InkPrinted EndotrachealTube Electrode	ISIS Headbox 5042XXand ISISNeurostimulator	ATECIOM Instruments
	parameters to assure anSAL of 10-6	parameters to assure anSAL of 10-6			parameters to assure anSAL of 10-6
Reusable/SingleUse	Guidewires, TargetingNeedles and Dilators –Single UseSafeOp Ball Tip Probe –Single UseAwls, Drills/Taps,Probes, Dilators(Sleeves), andScrewdrivers – Reusable	200, 300, and 400 LITe YNeedles – Single UseAwls, Taps, andScrewdrivers – Reusable	Single Use	Unknown	Guidewires, TargetingNeedles and Dilators –Single UseSafeOp Ball Tip Probe –Single UseAwls, Drills/Taps,Probes, Dilators(Sleeves), andScrewdrivers – Reusable
Compatible withCommonNeuromonitoringConsoles &Software	Yes	Yes	Yes	N/A includesNeuromonitoring Consoleand Software	Yes
Minimumexposed surfacearea	8.6 mm²	0.53 mm²	Unknown	2.0 mm²	5.94 mm²

Tablo 1: Summary of Taghnological Camparicon to Prodicatos

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VII. PERFORMANCE DATA

Performance testing includes IEC 60601-1 testing, and functional testing on insulation effectiveness and electrical resistance. Table 2 summarizes testing that was performed on the subject device to show substantial equivalence to the predicate devices. Testing results demonstrated the subject ATEC IOM Accessory Instruments are appropriate for neuromonitoring applications and are substantially equivalent when compared to other legally marketed devices cleared by FDA.

Test	Test Method Summary	Results
Electrical Safety Testingand/or Evaluation	Evaluation and testing was performedon the subject devices in accordancewith IEC 60601-1: 2005(R)2012.	All samples passedacceptance criteria
Functional PerformanceTesting and VerificationAnalysis	• Insulation Effectiveness• Electrical Resistance	All samples passedacceptance criteria
Reprocessing	• Cleaning validation or adoptionstudy based on acceptance criteriafrom AAMI TIR30:2011• Steam sterilization validation oradoption performed perANSI/AAMI/ISO 17665-1:2006/(R)2013.	All samples passedacceptance criteria

Table 2: Summarv of Performance Testing

Clinical Information

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

VIII. BIOCOMPATIBILITY DATA

A risk analysis was performed taking into account nature of body contact and duration to categorization the use of existing data, end-specific testing, and endpoint assessment to cover the identified test methods. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices.

Biocompatibility testing evaluated per ISO 10993-1.

Cytotoxicity
Sensitization ●
Irritation/Intracutaneous ●
Reactivity
Acute Systemic Toxicity
Material Mediated Pyrogenicity ●

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In conclusion, the ATEC IOM Accessory Instruments are manufactured from the same materials as other legally US-marketed devices.

IX. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.