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 at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space 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.

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 cavity that can be packed with autograft or allograft. STALIF C® is manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with titanium alloy screws (Ti6A14V, ASTM F136) and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F560). The STALIF C-Ti™ is identical to this design with a titanium plasma spray coating (CPT) per ASTM F1580) on the device endplates.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (STALIF C® and STALIF C-Ti™ intervertebral body fusion cages). This document details a regulatory submission for expanding the indications for use of an already cleared device, not the initial approval or a study explicitly proving acceptance criteria for a new device's performance.

Therefore, the information typically requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory document.

Here's what can be inferred and what is explicitly stated:

Device Type: The STALIF C® and STALIF C-Ti™ are intervertebral body fusion cages, which are physical implants. The "performance" in this context mainly refers to biomechanical properties, materials, and clinical safety/efficacy when used in the human body, not an AI algorithm's diagnostic performance.
Purpose of Submission: The current 510(k) (K150053) is to expand the indications of the device to allow its use in multilevel cervical procedures (one or two contiguous levels). The original device (K142079) was already cleared for single-level use.
"Study that proves the device meets the acceptance criteria": For this specific submission, the "study" primarily consists of:
- Clinical literature review: To assess additional safety concerns for multilevel use.
- PearlDiver reimbursement data: To investigate risks and benefits.
- Cadaveric biomechanical testing: Conducted to support substantial equivalence.

Given this context, I cannot fill out the requested table or answer most of your detailed questions because they pertain to diagnostic AI performance studies, which are not applicable to this physical implant's regulatory submission.

However, I can extract the following relevant information based on the provided text:

Acceptance Criteria and Device Performance (Not applicable in the AI sense for this implant)

This document does not present acceptance criteria for an AI algorithm's performance or a device performance table for diagnostic metrics. Instead, the "performance" discussed relates to the biomechanical and safety aspects of the physical implant for its expanded indication. The device is deemed "substantially equivalent" to its predicate based on design, material, and performance, which implies meeting established safety and effectiveness standards for such devices.

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

Not applicable / Not explicitly stated for AI diagnostic performance. The document focuses on demonstrating substantial equivalence for an expanded indication (multilevel use) of a physical implant. The "acceptance criteria" for a 510(k) submission are met by showing the device is as safe and effective as a legally marketed predicate. Performance is demonstrated through biomechanical testing and clinical literature review, not in terms of AI metrics.

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

Test Set Sample Size: "Cadaveric biomechanical testing was conducted." The specific number of cadavers or samples is not provided.
Data Provenance: Not specified for the cadaveric testing. The clinical literature review and PearlDiver reimbursement data are mentioned, but details on provenance (country, retrospective/prospective) are 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)

Not applicable. This pertains to a physical implant, not an AI diagnostic device. Ground truth in this context would implicitly relate to established biomechanical standards and clinical outcomes for spinal fusion, which are assessed by relevant specialists (e.g., orthopedic surgeons, biomechanical engineers), but specific numbers and qualifications of experts for a "ground truth" establishment are not mentioned for this type of submission.

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

Not applicable. Adjudication methods are typically for expert interpretation of diagnostic data, which is not the focus here.

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. An MRMC study is not mentioned as this is a physical medical implant, not an AI diagnostic tool.

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

Not applicable. This is a physical implant.

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

For the cadaveric biomechanical testing, the "ground truth" would be established biomechanical principles and measurements related to spinal stability and fusion construct integrity.
For the clinical literature review and PearlDiver data, the "ground truth" would be derived from a synthesis of published clinical outcomes data and real-world reimbursement trends related to spinal fusion procedures.
Specific, explicit statements on "ground truth" definition are not in the document.

8. The sample size for the training set

Not applicable. No AI algorithm is being trained here.

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

Not applicable. No AI algorithm is being trained here.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines forming its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

July 31, 2015

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

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

Re: K150053

Trade/Device Name: STALIF C® and STALIF C-TiTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 24, 2015 Received: June 24, 2015

Dear Mr. Eggleton:

This letter corrects our substantially equivalent letter of June 24, 2015.

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

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Page 2 - Mr. Justin Eggleton

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 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" (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 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,

Mark N. Melkerson -S

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

Enclosure

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K150053 Page 1 of 2

510(k) Summary

Device Trade Name:	STALIF C® and STALIF C-TiTM
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:	June 22, 2015
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	OVE
Primary Predicate:	K142079, STALIF C®, STALIF C-TiTM
Reference Device:	K142264, Amedica Valeo® Cage

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.

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K150053 Page 1 of 2

510(k) Summary

Device Trade Name:	STALIF C® and STALIF C-TiTM
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:	June 22, 2015
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	OVE
Primary Predicate:	K142079, STALIF C®, STALIF C-TiTM
Reference Device:	K142264, Amedica Valeo® Cage

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.

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K150053 Page 2 of 2

Summary of Technological Characteristics:

The purpose of the subject 510(k) was to expand the indications to allow for use in multilevel procedures (i.e., two contiguous levels).

Predicate Device:

The subject STALIF C and STALIF C-Ti™ intervertebral body fusion devices are substantially equivalent to predicate STALIF C-Ti™ (K142079) with respect to indications, design, function, and materials.

Substantial Equivalence:

STALIF C®, STALIF C-Ti™ and predicate STALIF C-Ti™ devices are identical in design, material, and performance. A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device (accounting for its integrated fixation features) at two cervical levels.

Performance Testing:

A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with the use of the STALIF C® devices in multilevel cervical procedures. Additionally, cadaveric biomechanical testing was conducted to support substantial equivalence.

Conclusion:

The Centinel Spine STALIF C® and STALIF C-Ti™ have been modified to expand the indications to permit use in multilevel cervical procedures (i.e., one or two contiguous levels). The 510(k) demonstrates substantial equivalence to predicate devices.

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150053

Device Name STALIF C® and STALIF C-TiTM

Indications for Use (Describe)

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 at one or two contiguous levels from the C2/C3 disc space 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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion.

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.

2 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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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.