Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct. Do not use any of the ATLANTIS® Anterior Cervical Plate System components with the components from any other system or manufacturer.

The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications.

The subject plates and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

AI/ML Overview

This document describes the ATLANTIS® Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis, and its substantial equivalence determination by the FDA based on non-clinical testing. This is a medical device submission, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the regulatory requirements for medical devices and the testing performed to demonstrate substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Non-clinical)	Reported Device Performance (ATLANTIS® Anterior Cervical Plate System)
Sterilization: Validation of sterilization parameters for gamma irradiation.	Sterilization assessments completed, and reports provided adequate evidence for validated sterilization parameters. Device is provided sterile by gamma irradiation.
Shelf Life: Package integrity for a specified shelf life.	Shelf life rationale indicates an eight-year shelf life for sterile subject device package integrity.
Mechanical Testing (ASTM F1717): - Compression fatigue - Static compression - Static torsion	Mechanical testing was completed in accordance with ASTM F1717 for compression fatigue, static compression, and static torsion. Test results determined the subject devices to be substantially equivalent to the predicate devices.
Biocompatibility: (Implied, as medical device materials need to be biocompatible)	The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy, a commonly accepted biocompatible material for surgical implants. Some plates have subcomponents from shape memory alloy (Nitinol-NiTi).
Substantial Equivalence: To legally marketed predicate devices in terms of intended use, overall dimensions, and fundamental scientific technology.	The subject devices were determined to be substantially equivalent to the predicate devices (K021461, K063100, K130640 ATLANTIS® Anterior Cervical Plate System and K141632 ZEVO® Anterior Cervical Plate System) based on non-clinical test results and additional supporting documentation.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the "sample size" for the mechanical testing in terms of number of devices or components tested. It only mentions that "Mechanical testing, in accordance with ASTM F1717, was also completed." ASTM F1717 outlines standard test methods for spinal implant constructs in a corpectomy model, which would include specific sample sizes based on the test type (e.g., typically at least 6 samples per group for static and fatigue testing).

The data provenance is non-clinical (laboratory testing), not patient data. Therefore, there is no country of origin of the data in the context of human subjects, nor is it retrospective or prospective in that sense. The testing was conducted by or for Medtronic Sofamor Danek USA, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of submission. The "ground truth" for non-clinical mechanical testing is established by adherence to recognized industry standards (ASTM F1717) and engineering principles, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This is not applicable as the study involves non-clinical mechanical testing, not clinical data requiring adjudication.

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

This is not applicable. The device is a physical spinal implant, not an AI software/diagnostic tool that would involve interpretation by human readers.

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

This is not applicable. The device is a physical spinal implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical testing is compliance with established engineering standards (ASTM F1717) and equivalence to the mechanical properties of predicate devices.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for physical device mechanical testing.

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

This is not applicable.

Summary

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

Medtronic Sofamor Danek USA, Incorporated Ms. Laveeda Leflore Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

November 12, 2015

Re: K152623

Trade/Device Name: ATLANTIS® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 11, 2015 Received: September 14, 2015

Dear Ms. Leflore:

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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Laveeda Leflore

forth in the quality systems (OS) 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" (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 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 yours.

Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K152623

Page 1 of 1

510(k) Number (if known)

K152623

Device Name

ATLANTIS® ANTERIOR CERVICAL PLATE 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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ATLANTIS® Anterior Cervical Plate System510(k) Summary – November 09, 2015
I. Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132(901) -396-3133Contact:Laveeda LefloreRegulatory Affairs Specialist
II. Proprietary Trade Name:	ATLANTIS® Anterior Cervical Plate System
III. Classification Name:	Spinal Intervertebral Body Fixation Orthosis(888.3060)
IV. Classification:	Class II
V. Predicate Devices	K021461 ATLANTIS® Anterior Cervical Plate System (S.E. 07/22/2002) – Primary PredicateK063100 ATLANTIS® Anterior Cervical Plate System (S.E. 02/23/2007)K130640 ATLANTIS® Anterior Cervical Plate System (S.E. 06/04/2013)K141632 ZEVO® Anterior Cervical Plate System (S.E. 12/04/2014)

VI. Product Codes: KWQ

VII. Product Description

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Cervical Plate System components with the components from any other system or manufacturer.

The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications.

The subject plates and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

VIII. Indications for Use

Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. 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 radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

VII. Summary of the Technological Characteristics

The subject devices are identical to the predicate in terms of intended use, overall dimensions, and fundamental scientific technology as the previously cleared predicates. Like the predicates, the subject plates and bone screws are available in titanium alloy. Also like the predicates, the plates are offered in sizes ranging from 19mm- 110mm, and the bone screws are offered in sizes 4.0mm and 4.5mm in diameter and 10-20mm in length. The subject plates and bone screws will be provided sterile.

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VIII. Identification of Legally Marketed Devices

The design features and indications for use for the sterile subject devices are substantially equivalent to the predicate ATLANTIS® Anterior Cervical Plate System (K021461, S.E. 07/22/2002; K063100 S.E. 02/23/2007; K130640 S.E. 06/04/2013) and ZEVO® Anterior Cervical Plate System (K141632 S.E. 12/04/2014).

IX. Discussion of Non-Clinical Testing:

Sterilization assessments were completed for the sterile subject plates and screws. These reports provide adequate evidence for the validated sterilization parameters. The shelf life rationale indicates that the sterile subject device package integrity has an eight year shelf life. Mechanical testing, in accordance with ASTM F1717, was also completed to support the subject device's substantial equivalence to the predicate devices. The test methods included compression fatigue, static compression, and static torsion. Compression fatigue, static torsion, and static compression testing were completed, and the test results determined the subject devices to be substantially equivalent to the predicate devices. A summary of the testing performed along with the complete test report is provided in the Bench Testing section of this submission.

Conclusion X.

Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, Medtronic believes that the subject devices demonstrated substantial equivalence to the listed predicate devices.

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.