The SKYLINE® Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: Instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthorosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myleopathy.

Device Description

The SKYLINE® System consists of cervical plates and screws which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain screws will be packaged in sterile multi-packs for customer convenience.

AI/ML Overview

This document pertains to a 510(k) premarket notification for the SKYLINE® Anterior Cervical Plate System. The core of this submission is about a change in the sterilization method (from non-sterile to terminally sterilized via gamma radiation) for an already cleared device. Therefore, the information provided focuses on the substantial equivalence to the predicate device based on this change, rather than a clinical study evaluating the device's clinical performance against specific acceptance criteria in the conventional sense of a diagnostic or AI-powered device.

As a result, many of the typical acceptance criteria and study details requested for an AI/diagnostic device (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of submission. This 510(k) is primarily concerned with verifying that the change in sterilization does not alter the fundamental safety, efficacy, or performance characteristics of the device, which is demonstrated through a comparison to a predicate device and assessment of manufacturing processes and materials.

Here's a breakdown based on the provided document, addressing the requested points where applicable and explaining why others are not relevant:

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

For this specific 510(k), acceptance criteria are not in the form of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are demonstrating substantial equivalence to the predicate device, particularly regarding the change in sterilization. The key "performance" reported is that the device remains functionally identical.

Acceptance Criteria (Implied)	Reported Device Performance
Safety & Efficacy with New Sterilization Method	Substantially equivalent to predicate device (K052552)
- Biocompatibility (Impact of Gamma Radiation on Materials)	Not required to be re-tested; the sterile devices do not require biocompatibility testing. The design, materials, and technology remain identical.
- Mechanical/Structural Integrity (Impact of Gamma Radiation)	Design, materials, and technology remain identical to the predicate systems. Implies no change in mechanical performance.
- Intended Use	Identical intended use as the predicate device (stabilization of cervical spine C2-C7).
- Materials	Manufactured from ASTM F-136 implant grade titanium alloy (identical to predicate).
Predicate Device Performance as Reference	The predicate device (K052552) was previously cleared and deemed safe and effective.

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

Not Applicable. This is not a study assessing diagnostic performance or clinical outcomes in humans that would require a test set of patient data. The "test" here involves demonstrating that the sterilized product is equivalent to the unsterilized predicate.

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

Not Applicable. There is no "ground truth" establishment in the context of clinical data for this type of submission. The evaluation is based on engineering, materials science, and regulatory compliance.

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

Not Applicable. See point 3.

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

Not Applicable. This device is a surgical implant, not an AI or diagnostic imaging device.

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

Not Applicable. This device is a surgical implant, not an algorithm.

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

Not Applicable. The "ground truth" for this submission revolves around established engineering standards, material specifications (ASTM F-136), and regulatory requirements for medical devices and sterilization methods, rather than clinical patient data. The primary "ground truth" is that the predicate device itself was previously cleared as safe and effective.

8. The sample size for the training set

Not Applicable. There is no training set 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.

Summary of the Study (as described in K103491):

The "study" or justification demonstrating the device meets the (implied) acceptance criteria is a substantial equivalence comparison to a previously cleared predicate device (SKYLINE® Anterior Cervical Plate System, cleared as the Hybrid Anterior Cervical Plate System, K052552).

Nature of the Study: This is a regulatory submission demonstrating that a modification (change to terminal gamma sterilization) to an existing device (SKYLINE® Anterior Cervical Plate System) does not alter its fundamental safety, efficacy, or performance compared to its predicate.
Key Argument: The design, materials (ASTM F-136 implant grade titanium alloy), and technology of the plates and screws remain identical to the predicate systems. The intended use also remains unchanged.
Biocompatibility: The submission states that the sterile devices do not require biocompatibility testing, implying that either the gamma sterilization is a well-understood process for these materials that does not negatively impact biocompatibility or that prior testing for the predicate already covered relevant considerations.
Conclusion: The submission concludes that the sterile SKYLINE® devices are as safe, as effective, and perform as well as the predicate device, thus establishing substantial equivalence.

In essence, the "study" is a technical and regulatory argument, based on established knowledge of materials and sterilization, rather than a clinical trial with human subjects and diagnostic performance metrics.

Summary

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510(K) SUMMARY

K103491
FEB 14 2011

A. Submitter Information

DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767

Contact Person:	Frank S. JurczakSr. Regulatory Affairs Associate
Voice:	(508) 828-3288
Fax:	(508) 828-3797
E-Mail:	FJurczak@its.jnj.com

B. Date Prepared 24 November 2010
C. Device Name

Trade/Proprietary Name:	SKYLINE® Anterior Cervical Plate System
Common/Usual Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification Name:	Spinal intervertebral body fixation orthosisper 21 CFR §888.3060

D. Predicate Device Name

Trade name: SKYLINE® Anterior Cervical Plate System, cleared as the Hybrid Anterior Cervical Plate System (K052552)

E. Device Description

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F. Intended Use

F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The proposed devices are identical to the predicate devices except that the proposed devices will be terminally sterilized by DePuy Spine via gamma radiation. The design, materials, and technology remain identical to the predicate systems.

Materials G.

Manufactured from ASTM F-136 implant grade titanium alloy.

H. Biocompatibility

The sterile SKYLINE® devices do not require biocompatibility testing.

Conclusion l.

The Substantial Equivalence Justification demonstrates that the device is as safe, as effective, and performs as well as the predicate device

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Food and Drug Administration i 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy Spine, Inc. % Mr. Frank S. Jurczak Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

FEB 14 2011

Re: K103491

Trade/Device Name: SKYLINE® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: January 14, 2011 Received: January 18, 2011

Dear Mr. Jurczak:

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 indictions 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 In Included in Intelsidio 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbrandinionny 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 micheding.

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

States of the country

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Page 2 – Mr. Frank S. Jurczak

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

AK B. R
for

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: SKYLINE® Anterior Cervical Plate System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIO3491 510(k) Number_

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.