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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ATEC IOM Accessory Instruments. This document focuses on demonstrating substantial equivalence to predicate devices based on design, technology, and performance data, not clinical performance data. Therefore, the information typically required to describe acceptance criteria and a study proving a device meets these criteria in the context of clinical performance (e.g., sample size for test sets, expert adjudication, MRMC studies, ground truth establishment) is largely absent.

However, the document does contain information about performance testing for non-clinical aspects. Below is an interpretation of the available information in the context of your request.

Please note: The document explicitly states "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means that the study you are asking about, which would typically involve human subject data and clinical endpoints, was not conducted or submitted for this 510(k) clearance. The performance data presented refers to engineering and safety testing.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Test Category	Test Method Summary	Acceptance Criteria	Reported Device Performance
Electrical Safety Testing	Evaluation and testing in accordance with IEC 60601-1: 2005.	"All samples passed acceptance criteria" (Implicitly, compliance with IEC 60601-1)	All samples passed acceptance criteria
Reliability Testing	Testing to verify no adverse effect on safety or effectiveness based on intended environment and storage conditions.	"All samples passed acceptance criteria" (Implicitly, device remains safe and effective after reliability tests)	All samples passed acceptance criteria
Functional Performance Testing	Insulation Effectiveness; Electrical Resistance	"All samples passed acceptance criteria" (Implicitly, functional specifications for insulation and resistance met)	All samples passed acceptance criteria
Biocompatibility Testing	Per ISO 10993-1, including Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility.	"All samples passed acceptance criteria" (Implicitly, compliance with ISO 10993-1 for these endpoints)	Biocompatibility testing was conducted and data was leveraged (e.g., existing data, end-specific testing, Master File, predicate and reference devices, well known materials) to support biocompatibility. The conclusion states the device materials are "manufactured from the same materials as other legally US-marketed devices" and implicitly passed the evaluation.

Information Regarding a Clinical Study (Not Applicable as per the Document)

As explicitly stated in the document, no clinical performance data was provided or relied upon for this 510(k) clearance. Therefore, the following points cannot be addressed from the given text as they pertain to clinical studies.

Sample size used for the test set and the data provenance: Not applicable for a clinical study. For the non-clinical tests, the sample sizes are not specified beyond "All samples passed," meaning at least one sample was tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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. This device is an instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical ground truth. For non-clinical tests, the ground truth would be defined by the testing standards (e.g., IEC 60601-1, ISO 10993-1).
The sample size for the training set: Not applicable for a clinical study. This device does not use a "training set" in the sense of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Clearance Basis:

The ATEC IOM Accessory Instruments are surgical tools designed to assist in locating nerves during spinal surgical procedures. Their clearance (K191723) was based on substantial equivalence to existing legally marketed predicate devices, specifically K182617 (ATEC IOM Accessory Instruments) and K132138 (Rhythmlink Disposable Concentric Stimulating Probe).

The substantial equivalence was demonstrated through:

Comparison of indications for use, design, function, and technology.
Compliance with relevant electrical safety standards (IEC 60601-1).
Reliability testing.
Functional performance testing (insulation effectiveness, electrical resistance).
Biocompatibility testing per ISO 10993-1, largely leveraging existing data and material characterization.

The crucial point is that this clearance did not involve a clinical performance study with human subjects, as the FDA determined it was not necessary to establish substantial equivalence for this type of device.

Summary

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October 18, 2019

Image /page/0/Picture/1 description: The image contains 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. Ms. Ruby Zheng Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K191723

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: September 16, 2019 Received: September 17, 2019

Dear Ms. Ruby Zheng:

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

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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,

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) K191723

Device Name ATEC IOM Accessory Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white stylized "a" inside of it. To the right of the square is the word "tec" in white font, with a trademark symbol in the upper right corner.

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.5818 El Camino RealCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
	Contact Person:	Ruby ZhengRegulatory Affairs Specialist
	Date Summary Prepared:	September 16, 2019

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

Predicate Device(s):

510(k)	Product Name	Clearance Date
K182617	ATEC IOM Accessory Instruments	May 9, 2019
K132138	Rhythmlink Disposable Concentric Stimulating Probe	April 11, 2014

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DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

TECHNOLOGICAL COMPARISON TO PREDICATES VI.

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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	Primary PredicateK182617	Additional PredicateK132138	Subject Device
Attribute	ATECIOM Instruments	Rhythmlink DisposableConcentric Stimulating Probe	ATECIOM Instruments
Indications for Use	The ATEC IOM AccessoryInstruments are utilized in spinesurgical procedures to assist inlocation of the nerves during orafter preparation and placement ofimplants (intervertebral fusioncages and pedicle screw fixationdevices) in open and percutaneousminimally invasive approaches.	The Rhythmlink DisposableConcentric Stimulating Probe isused to perform Intended Use(s)localized stimulation of neuraltissue and to locate, identify andmonitor cranial motor nerves,peripheral nerve and spinal nerveroots during surgery.The Rhythmlink DisposableConcentric Stimulating Probe is asingle patient use device	The ATEC IOM AccessoryInstruments are utilized in spinesurgical procedures to assist inlocation of the nerves during orafter preparation and placement ofimplants (intervertebral fusioncages and pedicle screw fixationdevices) in open and percutaneousminimally invasive approaches.
Regulation Number.Product Code, &	21 CFR 874.1820PDQ, ETN	21 CFR 874.1820ETN	21 CFR 874.1820PDQ, ETN
Classification	Class II	Class II	Class II
IEC 60601 Compliant	YesProtected Pin Design viacompatible clip/probeClause 56.3(c)	YesDIN 42 802 touch proof connectorsClause 56.3(c)	YesProtected Pin Design viacompatible clip/probeClause 56.3(c)
Instrument Type(Description)	Drills/Taps, Awls, Probes,Screwdrivers, Dilators (Sleeves),Guidewires, and Needles	Probes	Drills/Taps, Awls, Probes,Screwdrivers, Dilators (Sleeves),Guidewires, and Needles
Biocompatibility PatientContact Duration	Limited patient duration contact(≤ 24 hours)	Limited patient duration contact(≤ 24 hours)	Limited patient duration contact(≤ 24 hours)
Biocompatible	Yes	Yes	Yes
Surgical approach	Open or Percutaneous/MinimallyInvasive	Not specified	Open or Percutaneous/MinimallyInvasive
	Primary PredicateK182617	Additional PredicateK132138	Subject Device
Attribute	ATECIOM Instruments	Rhythmlink DisposableConcentric Stimulating Probe	ATECIOM Instruments
Sterility	Non-sterileNon-sterile devices are providedwith validated steam sterilizationparameters to assure an SAL of 10-6	Sterile via EtO	Sterile via EtO and non-sterileNon-sterile devices are providedwith validated steam sterilizationparameters to assure an SAL of 10-6
Reusable/Single Use	Guidewires, Targeting Needles andDilators - Single UseAwls, Drills/Taps, Probes, Dilators(Sleeves), and Screwdrivers -Reusable	Single Use	Guidewires, Targeting Needles andDilators - Single UseSafeOp Ball Tip Probe - SingleUseAwls, Drills/Taps, Probes, Dilators(Sleeves), and Screwdrivers -Reusable
Compatible with CommonNeuromonitoring Consoles& Software	Yes	Yes	Yes
Minimum exposed surfacearea	8.6 mm2	14.6 mm2	8.6 mm2

Table 1: Summary of Technological Comparison to Predicates

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VII. PERFORMANCE DATA

Performance testing includes IEC 60601-1 testing, reliability testing, and functional testing on insulation effectiveness and electrical resistance. Table 2 below summarizes the testing which was performed on the Subject Devices to show substantial equivalence to the Testing results demonstrated the subject ATEC IOM Accessory predicate device. Instruments are appropriate for neuromonitoring applications and do not introduce a new worst case compared to other legally marketed devices cleared by FDA.

Test	Test Method Summary	Results
Electrical Safety Testingand/or Evaluation	Evaluation and testing was performed onthe subject devices in accordance with IEC60601-1: 2005.	All samples passedacceptance criteria
Reliability Testing	Testing was performed to verify that thereis no adverse effect on the safety oreffectiveness of the subject devices basedon the intended environment and storageconditions.	All samples passedacceptance criteria
Functional PerformanceTesting and VerificationAnalysis	Insulation Effectiveness Electrical Resistance	All samples passedacceptance criteria

Table 2: Summary of Performance Testing

Clinical Information

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

BIOCOMPATIBILITY DATA VIII.

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 conducted per ISO 10993-1.

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

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Image /page/8/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white "a" inside of it, followed by the word "tec" in white. The background of the logo is dark blue.

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

CONCLUSION IX.

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.