The LDR Spine ROI-C Titanium-Coated Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The ROI-C Implants are to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

Device Description

The ROI-C Titanium-Coated Implant System consists of 'D' shaped blocks in two profiles, anatomic and lordotic, a variety of footprints within each profile, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat portion of the 'D' shape represents the anterior most portion of the device and includes features for attachment to instrumentation for insertion and slots for VerteBRIDGE® integrated fixation anchoring plates. The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) are coated with plasma-sprayed commercially pure titanium on the inferior and superior surfaces and feature two slots which allow for use with specially designed (and optional) supplemental fixation described below. The ROI-C Titanium-Coated Implant also features a tantalum radiographic marker on the posterior edge of the device. The VerteBRIDGE Anchoring Plates are made of titanium alloy (TiAl6V4) and can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The VerteBRIDGE Anchoring Plate used with ROI-C is curved, allowing it to be inserted into the ROI-C device in-line with the cage and then seated into the superior and inferior vertebral endplates. The ROI-C VerteBRIDGE Anchoring Plates are provided in two sizes: an 8mm length plate (intended for use with ROI-C devices height 4.5mm – 7mm) and a 9.5mm length plate (intended for use with ROI-C devices height 8mm -10mm). The anchoring plate locks into the ROI-C cage and provides stability to the construct via incorporated antiback out tabs and a central retaining ridge.

AI/ML Overview

The provided document is a 510(k) premarket notification for the LDR Spine ROI-C Titanium-Coated Implant System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (bench testing), rather than clinical studies proving efficacy in a human population. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device meets acceptance criteria in the context of clinical performance, ground truth, expert consensus, or AI/human reader studies.

Here's what the document does provide regarding performance and testing:

Non-Clinical Performance Data: The document details the non-clinical (bench) testing performed to support substantial equivalence. These tests are conducted to ensure the physical and mechanical properties of the device are adequate for its intended use and comparable to predicate devices.

1. A table of acceptance criteria and the reported device performance:
The document does not provide a table specifying quantifiable acceptance criteria and reported device performance values for the non-clinical tests. It only lists the types of tests performed. To report this, I would need access to the detailed test reports that accompanied the 510(k) submission.

Acceptance Criteria (Example for a fictional scenario): For Static Compression Testing, acceptance criteria might be "device must withstand X Newtons of force without permanent deformation or failure."
Reported Device Performance (Example for a fictional scenario): For Static Compression Testing, reported performance might be "device withstood Y Newtons of force, exceeding the acceptance criteria."

2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for the non-clinical bench tests. The data provenance is "Non-clinical performance bench testing" conducted by the manufacturer, LDR Spine USA. These are laboratory tests, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Non-clinical bench testing does not involve human subjects or expert consensus for ground truth on clinical outcomes. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM standards) and the physical properties observed in the laboratory.

4. Adjudication method for the test set:
This information is not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment.

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:
This information is not applicable. The device is an intervertebral body fusion implant, not an AI software/diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established engineering standards like ASTM F2077-11 for mechanical testing, and the observed physical properties of the materials and device. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of non-clinical bench testing for a surgical implant. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.

Summary of available information from the document:

Device: ROI-C Titanium-Coated Implant System (intervertebral body fusion device)
Indication: Degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1) in skeletally mature patients.
Purpose of Submission: To extend the line of currently available ROI-C cages to include cages that incorporate a titanium coating.
Performance Data Provided: Non-clinical (bench) testing only.
- Static and dynamic compression testing per ASTM F2077-11
- Static and dynamic compressive shear testing per ASTM F2077-11
- Static and dynamic torsion testing per ASTM F2077-11
- Subsidence testing and engineering analysis
- Static cage expulsion testing
- Static anchoring plate expulsion testing
- Wear testing & debris analysis
- Coating characterization
- MRI compatibility testing
Conclusion of Non-Clinical Testing: "The results of this non-clinical testing demonstrate that the strength and performance of the ROI-C Titanium-Coated Implant System are sufficient for its intended use and the device is therefore substantially equivalent to legally marketed predicate devices."
Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized profiles of human faces, stacked on top of each other.

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

December 7, 2015

LDR Spine USA Mr. James Wilson Regulatory Affairs Specialist 13785 Research Boulevard, Suite 200 Austin, Texas 78750

Re: K151934

Trade/Device Name: ROI-C Titanium-Coated Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: November 6, 2015 Received: November 9, 2015

Dear Mr. Wilson:

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 Parts 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" (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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Indications for Use

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

K151934

Page 1 of 1

510(k) Number (if known) K151934

Device Name

ROI-C Titanium-Coated Implant System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for LDR. The logo consists of a stylized eye-shaped graphic to the left of the letters "LDR" in a bold, dark blue font. Below the letters, there is the text "a passion for innovation" in a smaller, lighter blue font.

	510(k) Summary
Owner's Name & Address:	LDR Spine USA
	13785 Research Blvd. Suite 200
	Austin, TX 78750
Contact Person:	Mr. Jamie E. Wilson
	Regulatory Affairs Specialist
	Phone: (512) 344-3355
	Fax: (512) 795-8306
	Email: jamie.wilson@ldrspine.com
Date:	December 3, 2015
Trade Name:	LDR Spine Cervical Interbody Fusion System –
	ROI-C Titanium-Coated Implant System
Common Name:	Intervertebral body fusion device with integrated fixationcervical
Panel:	Orthopedic
Product Code:	OVE
Classification:	Class II, 21 CFR 888.3080
Predicate Devices:	Primary Predicate:
	LDR Spine Cervical Interbody Fusion System –
	ROI-C Lordotic Implants (K113559)
	Additional Predicates:
	X-Spine Irix-C Spinal Implant System (K131951)
	Centinel Spine Stalif-C® Ti (K133200)

Device Description:

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Image /page/4/Picture/0 description: The image is a logo for LDR, which stands for "a passion for innovation". The logo features a stylized human figure inside of an oval shape. The letters "LDR" are in bold, dark blue font. The text "a passion for innovation" is in a smaller, lighter blue font.

PEEK implants (PEEK OPTIMA LT1) are coated with plasma-sprayed commercially pure titanium on the inferior and superior surfaces and feature two slots which allow for use with specially designed (and optional) supplemental fixation described below. The ROI-C Titanium-Coated Implant also features a tantalum radiographic marker on the posterior edge of the device. The VerteBRIDGE Anchoring Plates are made of titanium alloy (TiAl6V4) and can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The VerteBRIDGE Anchoring Plate used with ROI-C is curved, allowing it to be inserted into the ROI-C device in-line with the cage and then seated into the superior and inferior vertebral endplates.

The ROI-C VerteBRIDGE Anchoring Plates are provided in two sizes: an 8mm length plate (intended for use with ROI-C devices height 4.5mm – 7mm) and a 9.5mm length plate (intended for use with ROI-C devices height 8mm -10mm). The anchoring plate locks into the ROI-C cage and provides stability to the construct via incorporated antiback out tabs and a central retaining ridge.

Indications for Use:

The LDR Spine ROI-C Titanium-Coated Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The ROI-C Implant System implants are to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

Purpose of this submission:

The purpose of this submission is to extend the line of currently available ROI-C cages to include cages that incorporate a titanium coating. This introduction of the ROI-C Titanium-Coated Implant System is not a response to any design deficiency or complaint.

Non-Clinical Performance Data:

Non-clinical performance bench testing conducted to support substantial equivalence for the ROI-C Titanium-Coated Implant System included:

. Static and dynamic compression testing per ASTM F2077-11
Static and dynamic compressive shear testing per ASTM F2077-11 ●
Static and dynamic torsion testing per ASTM F2077-11 .
Subsidence testing and engineering analysis ●

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Image /page/5/Picture/0 description: The image is a logo for LDR. The logo features a stylized human figure inside of an oval shape, followed by the letters "LDR" in a bold, sans-serif font. Below the letters is the text "a passion for innovation" in a smaller font.

Static cage expulsion testing
Static anchoring plate expulsion testing
Wear testing & debris analysis ●
. Coating characterization
. MRI compatibility testing

The results of this non-clinical testing demonstrate that the strength and performance of the ROI-C Titanium-Coated Implant System are sufficient for its intended use and the device is therefore substantially equivalent to legally marketed predicate devices.

Clinical Performance Data:

Clinical testing was not required to demonstrate substantial equivalence.

Basis of Substantial Equivalence:

The ROI-C Titanium-Coated Implant System is substantially equivalent to the predicate devices based on intended use and indications for use. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness and the scientific data from assessment of these characteristics demonstrate that the subject device is fit for its intended use and comparable to predicate devices. Therefore, the ROI-C Titanium-Coated Implant System overall is substantially equivalent to the 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.