The STALIF C® and STALIF C® Ti devices are 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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® and STALIF C® Ti are 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 or allograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.

AI/ML Overview

The provided text describes a 510(k) submission for the STALIF C® and STALIF C® Ti intervertebral body fusion devices, seeking to expand their indications to include use with allograft. This is a regulatory submission for a medical device, and the content focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance derived from a study, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document. The FDA 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering tests, material compatibility, and sometimes clinical literature reviews, rather than a clinical effectiveness study with defined performance metrics, a test set, and ground truth as might be seen for AI/diagnostic devices.

Here's what can be inferred or stated based on the provided text, and what cannot:

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

Cannot be provided directly. The document does not specify quantitative acceptance criteria for device performance (e.g., fusion rates, pain reduction scores, range of motion values) or report specific performance metrics from a study related to these criteria. The submission is about expanding indications based on clinical literature for allograft use.

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

Cannot be provided directly. No "test set" in the context of a performance study (like for an AI algorithm) is mentioned. The submission refers to a "comprehensive, clinical literature review" and "PearlDiver reimbursement data." These are not a single, defined test set with a specific sample size for a device performance study. Details on country of origin or retrospective/prospective nature of the literature reviewed are also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Cannot be provided directly. Since no specific "test set" requiring ground truth establishment by experts is described, this information is not available. The clinical literature review would involve evaluation of published studies, whose ground truth and expert evaluations would have been established within those individual studies.

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

Cannot be provided directly. This is not applicable as there is no described test set requiring expert adjudication for ground truth.

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 such study was done. This type of study (MRMC for AI assistance) is not relevant for this device, which is an intervertebral body fusion cage, not an AI diagnostic tool.

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

No such study was done. This question pertains to AI algorithms. The STALIF C® and STALIF C® Ti are physical medical implants.

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

Implied ground truth from literature review: The submission relies on "clinical literature review" and "PearlDiver reimbursement data" to suggest the benefits and risks of allograft. For fusion cages, the ultimate 'ground truth' related to effectiveness would typically be radiographic evidence of fusion and patient-reported outcomes (e.g., pain, disability scores) from clinical studies. The document states, "The clinical literature suggests that there is a positive benefit associated with allograft with minimal risk."

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" as this is not an AI/machine learning device.

Summary of what the document does state regarding demonstrating device appropriateness:

The submission aims to demonstrate "substantial equivalence" of the STALIF C® and STALIF C® Ti to the predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM.
The primary purpose of this specific 510(k) was to expand the indications to include use with allograft.
This expansion was supported by:
- A "comprehensive, clinical literature review" to investigate risks and benefits associated with using allogenic bone graft with the STALIF C®.
- "PearlDiver reimbursement data" also provided for the same purpose.
- No new mechanical tests were performed because there were no design changes to the device itself. The original device would have undergone mechanical testing to demonstrate safety and function.

In conclusion, the document provided is a regulatory clearance letter for a physical medical device (intervertebral body fusion cage) seeking an expanded indication. It does not contain information typically found in a study proving an AI device meets specific performance acceptance criteria.

Summary

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

October 24, 2014

Centinel Spine, Incorporated % Mr. Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K142079

Trade/Device Name: STALIF C® and STALIF C® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: July 30, 2014 Received: July 31, 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 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

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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 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.

Ronald P. Jean -S for

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

510(k) Number (if known) K142079

Device Name STALIF C® and STALIF C® Ti

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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4. 510(k) Summary

Device Trade Name:	STALIF C® and STALIF C® Ti
Manufacturer:	Centinel Spine, Inc.900 Airport Road, Suite 3BWest Chester, PA 19380
Contact:	Mr. John ParryDevelopment ManagerPhone: (484) 887.8813
Prepared by:	Mr. Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800jeggleton@mcra.com
Date Prepared:	July 30, 2014
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.

Summary of Technological Characteristics:

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with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.

The purpose of the subject 510(k) was to expand the indications to include use with allograft.

Predicate Device:

The subject STALIF C® and STALIF C® Ti intervertebral body fusion devices are substantially equivalent to predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) with respect to indications, design, function, and materials.

Substantial Equivalence:

STALIF C®, STALIF C® Ti and predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM are similar in design, material, and indicated use, and are both cleared devices. They do differ in that the ANATOMIC PEEK™ is indicated for use with allogenic bone graft. A comprehensive, clinical literature review has been conducted to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C". The clinical literature suggests that there is a positive benefit associated with allograft with minimal risk.

Performance Testing:

A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C. No new mechanical tests were performed since there were no design changes to the device.

Conclusion:

The Centinel Spine STALIF C® and STALIF C® Ti have been modified to expand the indications to permit use with allograft. The 510(k) demonstrates substantial equivalence to predicate devices.

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.