When used as a cervical intervertebral fusion devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems) systems) systems cleared for use in the cervical spine.

Device Description

The Camber Spine Coveris Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The Coveris Cervical Cage of intervertebral body fusion devices are made from the PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Coveris Cervical Cage System, a medical device for cervical intervertebral fusion. This documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the information requested for a study that proves the device meets acceptance criteria, an MRMC study, or detailed information about ground truth establishment, sample sizes for training/test sets, or expert qualifications for AI/algorithm performance.

The submission is based on:

Comparison to predicate devices: The primary method for proving substantial equivalence.
Nonclinical performance testing: Specifically, static compression and static torsion testing per ASTM F2077. These are engineering performance tests, not clinical performance studies with acceptance criteria in the sense of accuracy, sensitivity, or specificity.
Clinical literature review: To support the expanded indications for use with allogenic bone graft and at two contiguous levels. This is a review of existing data, not a new study with a test set.

Therefore, an AI system that correctly understands and states that the requested information is NOT present in the provided document would be performing well.

To directly address the prompt, while acknowledging the information is not present, here's how one might structure the answer if the document did contain such a study (and noting where it's absent):

The provided document describes a medical device called the Coveris Cervical Cage System, for which substantial equivalence to predicate devices is being demonstrated, rather than proving the device meets specific acceptance criteria via a new clinical performance study, especially not one relevant to AI/algorithmic performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement for a performance study is not present in the provided 510(k) summary.

The document's focus is on engineering performance (static compression and torsion) and a clinical literature review to justify expanded indications based on existing knowledge.

Here's a breakdown based on the information provided, and where it is absent for the specific type of performance study requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical performance study in the document. The "performance" described relates to non-clinical (mechanical) testing and the justification for expanded indications based on existing literature.
Reported Device Performance:
- Nonclinical Performance: "Static compression and static torsion testing were performed per ASTM F2077." No specific quantitative results or acceptance thresholds for these tests are provided, only that they were performed.
- Clinical Performance (literature review): The document states, "The clinical literature suggests that there is a positive benefit associated with allograft and use at two contiguous levels with minimal risk." This is a qualitative conclusion from a literature review, not a quantitative performance metric from a new study.

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

Not applicable / Not provided: The document does not describe a clinical "test set" in the context of proving device performance via a new study (e.g., for an AI algorithm). The literature review is based on existing published data, with no specific sample sizes mentioned for a new, dedicated test set.

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

Not applicable / Not provided: There is no mention of experts establishing ground truth for a test set, as no such performance study is described.

4. Adjudication Method for the Test Set:

Not applicable / Not provided: No test set or adjudication method is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

No: The document does not describe an MRMC study. The device is a physical intervertebral fusion cage, not an imaging or diagnostic AI system that would typically undergo such a study.

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

Not applicable: The device is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable / Not provided: As no primary data collection for performance evaluation (e.g., for an AI/diagnostic device) is described, the concept of "ground truth" for a test set is not relevant here. The "ground truth" for the expanded indications relies on the conclusions drawn from existing clinical literature.

8. The Sample Size for the Training Set:

Not applicable / Not provided: This concept is not relevant for the type of device and submission described.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not provided: This concept is not relevant for the type of device and submission described.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Camber Spine Technologies % Margeaux Rogers Senior Associate, Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001 July 13, 2017

Re: K170550

Trade/Device Name: Coveris Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 22, 2017 Received: June 23, 2017

Dear Ms. Rogers:

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

Image /page/0/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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.

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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Indications for Use

510(k) Number (if known)

K170550

Device Name Coveris Cervical Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CER 801 Subpart D)	□ Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary

Device Trade Name:	Coveris Cervical Cage System
Manufacturer:	Camber Spine Technologies418 E. Lancaster Ave.Wayne, PA 19087
Contact:	Mr. Joseph NyahayProduct Development EngineerCamber Spine Technologies418 E. Lancaster Ave.Wayne, PA 19087
Prepared by:	Ms. Margeaux RogersMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5800mrogers@mcra.com
Date Prepared:	February 23, 2017
Classification:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	ODP

Indications For Use:

When used as a cervical intervertebral fusion device, the Coveris devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems, or posterior systems) systems cleared for use in the cervical spine.

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Device Description:

Predicate Device:

The primary predicate is the Coveris Cervical Cage System (K133529). The Medtronic Anatomic PEEK PTC Cervical Fusion System (K160528) is an additional predicate. The subject Coveris Cervical Cage System is substantially equivalent to the previously cleared Coveris Cervical Cage System (K133529) with respect to design, function and materials and predicate Medtronic Anatomic PEEK PTC Cervical Fusion System (K160528) with respect to indications, design, function, and materials.

Substantial Equivalence:

The Coveris Cervical Cage System and predicate Medtronic Anatomic PEEK PTC Cervical Fusion System (K160528) are similar in design, material, and indicated use, and are both cleared devices. They do differ in that the Medtronic Anatomic PEEK PTC Cervical Fusion System is indicated for use with allogenic bone graft at one or two contiguous levels. A comprehensive, clinical literature review has been conducted to investigate the risks and benefits associated with using allogenic bone graft with the Coveris Cervical Cage System and mutli-level use. The clinical literature suggests that there is a positive benefit associated with allograft and use at two contiguous levels with minimal risk.

Nonclinical Performance Testing:

Comprehensive, clinical literature review data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the Coveris Cervical Cage System and use at two contiguous levels. Static compression and static torsion testing were performed per ASTM F2077.

Conclusion:

The Coveris Cervical Cage System has been modified to expand the indications to permit use with allograft and use at two contiguous levels, C2-T1. 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.