The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

Device Description

The ATEC ALIF and LLIF Spacer System is an intervertebral body fusion system. The ATEC ALIF and LLIF Spacer System includes interbody implants marketed as Battalion Universal Spacer System and IdentiTi Porous Ti Spacer System, implanted from an anterior, anterolateral and lateral approach. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.

The ATEC ALIF and LLIF Spacer System also includes LLIF AMP integrated fixation to be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.

AI/ML Overview

The provided text is a 510(k) summary for the ATEC ALIF and LLIF Spacer System, which is an intervertebral body fusion system. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, and therefore does not require a Premarket Approval (PMA).

Crucially, this document is for a medical device (a physical implant) and not for an AI/ML-driven device or diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML model (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable here.

The "performance data" section in this document refers to nonclinical testing (mechanical, material, and biocompatibility testing) to demonstrate the physical device's safety and performance in a lab setting, and its substantial equivalence to other predicate devices.

Here's why the requested information cannot be extracted from this document:

AI/ML Model: The device is an intervertebral body fusion system, not an AI/ML diagnostic or assistive tool.
Performance Metrics: The "acceptance criteria" for this type of device are related to biomechanical properties (e.g., resistance to compression, shear, subsidence, push-out), material compatibility, and endotoxin levels, not diagnostic performance metrics like sensitivity, specificity, or AUC.
Clinical Studies (in the context of AI/ML): The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means formal clinical trials or multi-reader, multi-case (MRMC) studies with human readers were not required for this 510(k) clearance, as equivalence was demonstrated through nonclinical data and comparison to existing predicate devices.
Ground Truth, Experts, Sample Sizes (for AI/ML): These concepts are entirely irrelevant for the clearance of a physical implant like the ATEC ALIF and LLIF Spacer System. There's no "ground truth" to establish for an AI model's output, no "experts" establishing image labels, and no "training/test sets" of data in the AI/ML sense.

In summary, the provided document does not contain the information requested because it pertains to the clearance of a physical medical implant, not an AI/ML-powered device.

Summary

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Image /page/0/Picture/0 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.

November 27, 2018

Alphatec Spine, Inc. Ms. Cynthia Adams Project Manager, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008

Re: K182746

Trade/Device Name: ATEC ALIF and LLIF Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: September 27, 2018 Received: September 28, 2018

Dear Ms. Adams:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (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.html; 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.

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182746

Device Name ATEC ALIF and LLIF Spacer System

Indications for Use (Describe)

The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

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

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510k Summary ATEC ALIF and LLIF Spacer System K182747

I.	SUBMITTER:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
	Contact Person:	Cynthia AdamsProject Manager, Regulatory AffairsContact Phone: (760) 494-6740

Date Summary Prepared: September 27, 2018

II. DEVICE

Name of Device:	ATEC ALIF and LLIF Spacer System
Common or Usual Name:	Intervertebral fusion device with bone graft, lumbar
Classification Name:	Intervertebral body fusion device
	(21 CFR 888.3080)
Regulatory Class:	Class II
Product Code:	MAX, PHM, OVD

III. LEGALLY MARKETED PREDICATE DEVICES

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K180480	PHM, MAX	ATEC Universal Spacer System	Alphatec Spine
Additional Predicate Devices
K181453	PHM, MAX	ATEC ALIF Spacer System	Alphatec Spine
K160958	PHM, MAX	Battalion Universal Spacer System	Alphatec Spine
K090782	MAX	Novel ALIF Spinal Spacer System	Alphatec Spine
K143740	MAX	Battalion Universal Spacer System	Alphatec Spine
K101255	KWQ	Anterior Lumbar Plating System	Alphatec Spine
K163543	MAX, OVD	Zimmer Biomet Fusion System	Zimmer Biomet
K173892	MAX, PHM, OVD	XLX Interbody System	NuVasive Inc.
K121791	KWQ	Zou® Anterior Lumber PlateSystem	CoreLink LLC
K102402	OVD	Solus Anterior Lumbar InterbodyFusion System	Alphatec Spine

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

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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.

VII. PERFORMANCE DATA

Nonclinical testing performed on the ATEC ALIF and LLIF Spacer System supports substantial equivalence to other predicate devices. The following testing was performed:

Dynamic axial compression testing per ASTM F2077
Dynamic compression-shear testing per ASTM F2077 .
Subsidence analysis .
Push-out testing per ASTM F04-25-02-02 draft ●
Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714 ●
Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●

The results demonstrate that the subject ATEC ALIF and LLIF Spacer System is substantially equivalent to other predicate devices for nonclinical testing.

Clinical Information

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

CONCLUSION VIII.

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

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.