The ATLANTIS ® Anterior Cervical plate system is intended for anterior interbody screw fixation from C2 to T1 in the cervical spine. 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) pseudoathrosis. 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 is intended for the anterior screw fixation from C2 to T1 in the cervical spine. The device is manufactured from titanium alloy. Stainless steel and titanium implant components must not be used together in a construct.

The ATLANTIS® Anterior Cervical Plate System consists of plates of various lengths and screws. 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 is to be used with cleared cervical supplemental instrumentation.

AI/ML Overview

This document describes a 510(k) submission for the MEDTRONIC Sofamor Danek ATLANTIS® Anterior Cervical Plate System. It is a medical device for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical performance studies or algorithm-based evaluations. Therefore, many of the requested categories related to acceptance criteria, specific study designs (like MRMC or standalone performance studies for algorithms), ground truth establishment for AI/ML, and sample sizes for training/test sets are not applicable or cannot be extracted from this type of regulatory document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for Performance, but for Equivalence)	Reported Device Performance / Assessment
Material Composition	Manufactured from titanium alloy.
Device Configuration	Consists of plates of various lengths and screws, intended for anterior screw fixation from C2 to T1.
Intended Use / Indications	Temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease, 2) trauma, 3) tumors, 4) deformity, 5) pseudoarthrosis, and/or 6) failed previous fusions. Intended for anterior cervical intervertebral body fusions only.
Sterilization	Acceptance Criteria (Implied): Device must be demonstrably sterile and maintain sterility for its shelf life. Reported Performance: Sterilization assessments were completed for sterile subject plates and screws. Reports provide adequate evidence for validated sterilization parameters.
Packaging	Acceptance Criteria (Implied): Packaging must maintain device sterility and integrity for its shelf life.Reported Performance: Shelf life rationales show sterile subject device package integrity with an eight-year shelf life.
Substantial Equivalence to Predicate Device	Acceptance Criteria: Device must demonstrate substantial equivalence to legally marketed predicate devices in terms of design features, materials, and indications for use.Reported Performance: The device is deemed substantially equivalent to the predicate ATLANTIS® Anterior Cervical Plate System (K021461 and K081038) based on sterilization and packaging rationales and other supporting documentation. FDA concurrence signifies this equivalence.

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

Not Applicable. This submission is for a physical medical device (spinal plate system), not an AI/ML-based diagnostic or imaging device requiring a test set of data samples. The "study" mentioned refers to non-clinical testing for equivalence, primarily focused on sterilization and packaging.

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

Not Applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/ML or diagnostic performance study.

4. Adjudication method for the test set

Not Applicable. No test set or related adjudication is described.

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 is a physical implantable device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this submission.

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

No. This is a physical implantable device; it does not involve an algorithm for standalone performance.

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

Not Applicable. Given that this is a 510(k) for a physical medical device, the concept of "ground truth" in the context of diagnostic accuracy or AI/ML performance is not relevant. The "truth" here is related to the physical and functional characteristics of the device (sterility, mechanical integrity, material composition) and its equivalence to a predicate device.

8. The sample size for the training set

Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not Applicable. There is no training set or related ground truth to establish.

Summary

{0}------------------------------------------------

510(k) Summary

MEDTRONIC Sofamor Danek ATLANTIS® Anterior Cervical Plate System March 8, 2013

JUN 0 4 2013

I. Company:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133
II. Contact:	Kristi FrischRegulatory Affairs SpecialistTelephone: (901) 399-2221Fax: (901) 346-9738
III. Proposed Proprietary Trade Name:	ATLANTIS® AnteriorCervical Plate System
IV. Classification Names:Class:	Spinal IntervertebralBody Fixation OrthosisII

V. Description:

Product Code:

KWQ (21 CFR 888.3060)

{1}------------------------------------------------

VI. Indications for Use:

The ATLANTIS® Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2-T1 in the cervical spine. 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) pseudoathrosis, 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 purpose of this 510(k) submission is to seek clearance for subject parts which are provided sterile.

VIII. Identification of Legally Marketed Devices:

The design features and indications for use for the sterile subject are substantially equivalent to the predicate ATLANTIS® Anterior Cervical Plate System (K021461, S.E. 07/22/2002 and K081038, S.E. 08/15/2008)

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. Shelf life rationales show sterile subject device package integrity with an eight year shelf life.

X. Conclusion:

Based on the sterilization and packaging rationales and other supporting documentation provided in this pre-market notification, Medtronic believes that the sterile subject device demonstrates substantial equivalence to the listed predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, alongside the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and monochromatic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 4, 2013

Medtronic Sofamor Danek USA, Incorporated % Ms. Kristi Frisch Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K130640

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: April 5, 2013 Received: April 8, 2013

Dear Ms. Frisch:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Kristi Frisch

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Erin.D.Keith
For.

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

Enclosure

{4}------------------------------------------------

5 I 0(k) Number (if known):

K130640 Page 1 of 1

Device Name: ATLANTIS® Anterior Cervical Plate System

Indications for Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

· AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic 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.