The ZION Anterior Cervical Fixation System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) defined as kyphosis, or scoliosis, 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

Device Description

The Astura Medical ZION Anterior Cervical Fixation System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The ZION ACFS plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with self-tapping or self-drilling thread options.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the ZION Anterior Cervical Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth from a diagnostic accuracy study is not applicable or available in this type of submission.

Here's a breakdown of the relevant information provided in the document:

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

The document does not present specific clinical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for diagnosis or treatment outcomes. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the non-clinical testing performed on the ZION system.

Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (Non-Clinical)
Mechanical integrity under static and dynamic compression (per ASTM F1717)	Met standards, showing equivalence to predicate devices.
Mechanical integrity under static torsion (per ASTM F1717)	Met standards, showing equivalence to predicate devices.
Corrosion resistance (per ASTM F2129)	Met standards, showing equivalence to predicate devices.
Biocompatibility (implied by material use - Ti-6Al-4V ELI & Nitinol)	Based on use of established biocompatible materials, assumed to be equivalent to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. No clinical test set data is provided. The tests were non-clinical (mechanical and corrosion testing of the device itself).
Data Provenance: Not applicable. The data comes from laboratory non-clinical testing, not human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set and thus no ground truth established by experts in a diagnostic context. The testing involved engineers and technicians conducting mechanical and material evaluations against established ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no clinical test set was used, there was no adjudication method for establishing ground truth from expert consensus.

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

No. This type of study is not relevant for a spinal fixation system 510(k) submission. MRMC studies are typically for diagnostic imaging software or AI-assisted diagnostic tools.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The ZION Anterior Cervical Fixation System is a physical implant, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering standards (ASTM) for mechanical strength and material properties. The device is shown to meet these standards and to be equivalent to predicate devices that have prior FDA clearance based on similar evidence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. The device is not an AI or machine learning system that requires training data.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2016

Astura Medical % J.D. Webb President The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K160702

Trade/Device Name: ZION Anterior Cervical Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 17, 2016 Received: August 18, 2016

Dear J.D Webb:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

VincentJ. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160702

Device Name

ZION Anterior Cervical Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

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510(k) Summary: ZION Anterior Cervical Fixation System

Date Prepared	May 20, 2016
Submitted By	Astura Medical5670 El Camino Real, Suite BCarlsbad, CA 92008760-814-8047 Teleemail: info@asturamedical.com
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net
Trade Name	ZION Anterior Cervical Fixation System
Common Name	anterior cervical plate
Classification Name	Spinal intervertebral body fixation orthosis
Class	II
Product Code	KWQ
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
Primary PredicateDevice	Zimmer Trinica/Trinica Select Anterior Cervical Plate (K132012)
Secondary PredicateDevices	Spinal USA Slimpicity Anterior Cervical Plating System (K060025)Biomet C-TekV MaxAnrm Anterior Cervical Plate System (K080646)Synthes CLSP Cervical Plate (K000536)DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070)
Device Description	The Astura Medical ZION Anterior Cervical Fixation System is intended foranterior screw fixation of the plate to the cervical spine. The fixation constructconsists of a cervical plate that is attached to the vertebral body of the cervicalspine with self-tapping or self-drilling bone screws using an anterior approach.Plates are available in a variety of lengths addressing multiple levels offixation. The ZION ACFS plate incorporates graft windows on thelongitudinal center line for intraoperative visualization and for screwfixation of bone graft. Fixed or variable bone screws are available in twodiameters and a variety of lengths, with self-tapping or self-drilling threadoptions.
Materials	Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136Nitinol conforming to ASTM F2063
SubstantialEquivalence Claimedto Predicate Devices	The ZION Anterior Cervical Fixation System is substantially equivalent to thepredicate devices in terms of intended use, design, materials used, mechanicalsafety and performances.
Indications for Use	The ZION Anterior Cervical Fixation System is intended for anterior screwfixation to the cervical spine. It is to be used in skeletally mature patients as anadjunct to fusion of the cervical spine (C2 to T1). The system is indicated for usein the temporary stabilization of the anterior spine during the development ofcervical spinal fusions in patients with: 1) degenerative disc disease (as definedby neck pain of discogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies), 2) spondylolisthesis, 3) trauma(including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis,lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8)spinal stenosis.
Non-clinical TestSummary	The following analyses were conducted:● Static and dynamic compression testing per ASTM F1717● Static torsion testing per ASTM F1717● Corrosion testing (ASTM F2129)The results of these evaluations indicate that the ZION Anterior Cervical FixationSystem is equivalent to the predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Astura Medical considers the ZION Anterior Cervical Fixation System to beequivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation,technology, materials and indications for use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.