The Aspida Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.

The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:

Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Trauma (i.e., fracture or dislocation)
Spinal stenosis
Unsuccessful previous fusion surgery
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor

Device Description

The Aspida Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136. The system also contains Class I manual instruments. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

AI/ML Overview

The provided text describes the Aspida® Anterior Lumbar Plating System (K182808). However, it does not contain information about acceptance criteria or a study proving device meeting acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a traditional medical device (spinal intervertebral body fixation orthosis). The "performance data" section (page 5) refers to nonclinical testing of the physical device's mechanical properties (static compression, static torsion, dynamic compression per ASTM F1717) to demonstrate substantial equivalence to predicate devices, not performance evaluation of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets them based on the given text.

The bullet points below indicate what information is not present in the document based on the request's context for an AI/ML device:

A table of acceptance criteria and the reported device performance: Not applicable; the document concerns a physical implant, not an AI/ML device with performance metrics like sensitivity or specificity.
Sample sized used for the test set and the data provenance: Not applicable; no AI/ML test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no AI/ML test set or expert ground truth is described.
Adjudication method: 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: 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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2018

Alphatec Spine, Inc. Ms. Ruby Zheng Regulatory Affairs Compliance Specialist 5818 El Camino Real Carlsbad, California 92008

Re: K182808

Trade/Device Name: Aspida® Anterior Lumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 2, 2018 Received: October 3, 2018

Dear Ms. 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/cdrl/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

Ronald P. Jean -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)

K182808

Device Name Aspida® Anterior Lumbar Plating System

Indications for Use (Describe)

The Aspida Anterior Lumbar Plating System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the great vessels. The device is intended as a temporary fixation device until fusion is achieved.

The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:

Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis

1. Trauma (i.e., fracture or dislocation)
1. Spinal stenosis
1. Unsuccessful previous fusion surgery
1. Deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis)
1. Tumor

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)	✓ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
✓ 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 letter "a" inside of it. To the right of the square is the word "tec" in white font, with a trademark symbol above the "c".

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) 431-6884Fax: (760) 431-0289
	Contact Person:	Ruby ZhengRegulatory Affairs Compliance SpecialistContact Phone: (760) 494-6884
	Date Summary Prepared:	November 8, 2018

II. DEVICE

Name of Device:	Aspida® Anterior Lumbar Plating System
Common or Usual Name:	Spinal Intervertebral Body Fixation Orthosis
Classification Name:	Appliance, Fixation, Spinal Intervertebral Body(21 CFR 888.3060)
Regulatory Class:	Class II
Product Code:	KWQ

III. LEGALLY MARKETED PREDICATE DEVICES

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K101255	KWQ	Alphatec Spine Anterior LumbarPlating System	Alphatec Spine
Additional Predicate Device
K090222	KWQ	Pioneer Lumbar Plate System	Pioneer SurgicalTechnology

IV. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for a company called "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 sans-serif font. The letters are connected to each other. The background of the image is a dark blue color.

V. INDICATIONS FOR USE

The Aspida Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:

Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)

1. Pseudoarthrosis
1. Spondylolysis
1. Spondylolisthesis
1. Trauma (i.e., fracture or dislocation)
1. Spinal stenosis
1. Unsuccessful previous fusion surgery
1. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
1. Tumor

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 Aspida Anterior Lumbar Plating System supports substantial equivalence to other predicate devices. The following testing was performed:

Static compression testing per ASTM F1717
Static torsion testing per ASTM F1717 ●
. Dynamic compression testing per ASTM F1717

The results demonstrate that the subject Aspida Anterior Lumbar Plating 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.

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Image /page/5/Picture/0 description: The image is a logo for a company called "atec". The logo consists of a green square with rounded corners on the left side, and the word "atec" in white letters on the right side. The "a" in "atec" is stylized with a curved line that resembles the Greek letter alpha. There is a trademark symbol after the "c" in "atec".

K182808 Page 3 of 3

VIII. 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

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.