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 nonoperative 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 sevity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560).

AI/ML Overview

The provided text describes a medical device, the STALIF C®, and its substantial equivalence to predicate devices, but does not contain information regarding an acceptance criteria study for device performance in the context of AI/ML or diagnostic accuracy.

The provided document, K120819, is a 510(k) summary for a medical device (intervertebral body fusion cage) which is primarily concerned with demonstrating substantial equivalence to previously cleared devices through mechanical testing and FEA simulation. This is a premarket notification for a physical medical device, not a software as a medical device (SaMD) or AI-powered diagnostic tool.

Therefore, I cannot fulfill the request as it pertains to AI/ML specific criteria and studies, as this information is not present in the provided text.

The closest relevant information is about the mechanical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Defined in Design Control Activities Summary)	Device Performance
Mechanical testing per ASTM F2077 (static and dynamic compression)	Met acceptance criteria
Mechanical testing per ASTM F2077 (static and dynamic compression-shear)	Met acceptance criteria
Mechanical testing per ASTM F2077 (static and dynamic torsion testing)	Met acceptance criteria
FEA simulation on worst-case subject STALIF C® and predicate STALIF C™	Showed previous testing in K072415 was adequate (implying equivalence met)

The following points cannot be answered from the provided text as they relate to AI/ML or diagnostic performance studies, which are not detailed in this 510(k) submission for a physical implantable device:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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K12 0819

510(k) Summary

Device Trade Name:	STALIF C®	AUG 3 1 2012
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:	Mr. Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	May 4, 2012
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 nonoperative treatment prior to implantation of the cage.

Device Description:

Page 1 of 2

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LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560).

Predicate Device:

The subject STALIF C® intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K072415), Stryker Spine Anchor-C Cervical Cage System (K102606), Spinal Elements Mosaic Cage (K071833), and the Medtronic Affinity Cages (P000028), with respect to indications, design, function, and materials.

Substantial Equivalence:

FEA simulation was performed on the worst case subject STALIF C® and predicate STALIF CTM to show the previous testing in K072415 was adequate. Additional mechanical testing per ASTM F2077 (e.g., static and dynamic compression, static and dynamic compression-shear, and static and dynamic torsion testing) was performed on the worst-case device. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

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

AUG 3 1 2012

Centinel Spine, Incorporated % Mr. John Parry Development Manager 900 Airport Road, Suite 3B West Chester, Pennsylvania 19380

Re: K120819

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: August 02, 2012 Received: August 06, 2012

Dear Mr. Parry:

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

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Page 2 - Mr. John Parry

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/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Milliken

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 4.

510(k) Number (if known):

Device Name: STALIF C®

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.

Prescription Use ج AND/OR (Part 21 CFR 801 Subpart D) .

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)

Carl Rfi
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120819

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.