The STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF C® is intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Device Description

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LTI with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The purpose of this 510(k) was to include a titanium coating (ASTM F1580) on both endplates.

AI/ML Overview

Acceptance Criteria and Study for STALIF C®

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Mechanical Soundness	Static Compression	Met ASTM F2077 standards (implied, as the study states criteria were met)	Met acceptance criteria defined in Design Control Activities Summary
	Static Compression-Shear	Met ASTM F2077 standards (implied)	Met acceptance criteria defined in Design Control Activities Summary
	Dynamic Compression	Met ASTM F2077 standards (implied)	Met acceptance criteria defined in Design Control Activities Summary
	Dynamic Torsion	Met ASTM F2077 standards (implied)	Met acceptance criteria defined in Design Control Activities Summary
	Dynamic Compression-Shear	Met ASTM F2077 standards (implied)	Met acceptance criteria defined in Design Control Activities Summary
	Expulsion	Met ASTM F2267 standards (implied)	Met acceptance criteria defined in Design Control Activities Summary
	Subsidence	Met ASTM F2267 standards (implied)	Met acceptance criteria defined in Design Control Activities Summary

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each mechanical test. It mentions that "Testing performed indicate that the STALIF C® is as mechanically sound as predicate devices," suggesting the tests were performed on the device itself.

The data provenance is from laboratory testing (mechanical testing), not from patient data, and is therefore neither retrospective nor prospective in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for this device is based on mechanical engineering standards (ASTM F2077 and F2267) and the device's ability to meet those established criteria, not on expert clinical interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" is determined by whether the device's performance meets the defined mechanical standards, rather than expert consensus on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not conducted as this is a medical device (intervertebral body fusion cage), not an AI algorithm or diagnostic tool that relies on human interpretation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established mechanical engineering standards (ASTM F2077 and F2267) for intervertebral body fusion devices. The device's performance was compared against these universally recognized standards for mechanical soundness.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model, so there is no "training set." The device itself underwent the mechanical tests.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it. The standards (ASTM F2077 and F2267) that define the "ground truth" for mechanical performance were established by industry experts and regulatory bodies.

Summary

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K133200 Page 1 of 2

MAY 08 2014

5. 510(k) Summary

Device Trade Name:	STALIF C®
Manufacturer:	Centinel Spine, Inc.900 Airport Road, Suite 3BWest Chester, PA 19380
Contact:	Mr. John ParryDevelopment ManagerPhone: (484) 887.8813J.Parry@centinelspine.com
Prepared by:	Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	October 15, 2013
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	OVE

Indications For Use:

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Device Description:

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with central cavity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LTI with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The purpose of this 510(k) was to include a titanium coating (ASTM F1580) on both endplates.

Predicate Device:

The subject STALIF C® intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K120819, K072415) with respect to indications, design, function, and materials.

Substantial Equivalence:

Testing performed indicate that the STALIF C® is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077 and F2267. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.

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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 eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 8, 2014

Centinel Spine. Incorporated % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street Northwest, 1210 Floor Washington. District of Columbia 20005

Re: K133200

Trade/Device Name: STALIF C® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: April 7, 2014 Received: April 8, 2014

Dear Mr. Eggleton:

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 substantíal 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) (2) CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Justin Eggleton

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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.goy/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

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

Enclosure

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K133200

Indications for Use 4.

510(k) Number (if known): K133200

Device Name: STALIF C®

The STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inscrted between the vertebral bodies into the disc. space from levels C2 to Ti for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF C® is intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

ج Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedie Devices 510(k) Number: K133200

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.