The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity.

· Spondylolisthesis,

· Spondylolysis.

· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,

· Degeneration of the facets with instability,

· Trauma including spinal fractures and/or dislocations.

Device Description

The FacetBRIDGE® System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion.

Each FacetBRIDGE® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.

AI/ML Overview

This document is a 510(k) premarket notification for the FacetBRIDGE® System, specifically for a line extension that includes an additional washer design. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study of the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable/provided in this document in the context of device performance as typically defined for new medical devices requiring extensive clinical data.

Here's what can be extracted based on the provided text, and where information is missing:

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

Acceptance Criteria (Bench/Non-Clinical)	Reported Device Performance
Engineering and dimensional analysis	Complied / Performed
Functional verification utilizing sawbones	Complied / Performed
Endotoxin Testing	Complied / Performed

Explanation: The document states that the purpose of the submission is to introduce a line extension and that the non-clinical performance bench testing conducted was to support substantial equivalence. The "performance" described here is in the context of ensuring the new washer design does not negatively impact existing functionality or mechanical strength. No specific quantitative performance metrics (e.g., maximum load, fatigue cycles, specific dimensional tolerances) or their corresponding acceptance thresholds are provided in this summary. Instead, a general statement of compliance or completion of these tests is made.

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: Not specified. The document mentions "functional verification study utilizing sawbones" but does not give a sample size (e.g., number of sawbones tested, number of devices tested on sawbones).
Data Provenance: Not specified. Given it's non-clinical bench testing, geographical provenance is less relevant than for clinical data. The study appears to be proprietary data from the manufacturer (LDR Spine USA, Incorporated). It is a non-clinical, prospective bench study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/provided. This was a non-clinical bench study. Ground truth in this context would typically refer to objective measurements from engineering tests rather than expert interpretation.

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

Adjudication Method: Not applicable/provided. This was a non-clinical bench study.

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

MRMC Study: No. This is not applicable to a non-clinical submission for a spinal implant. It's a physical medical device, not an AI or diagnostic software.

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

Standalone Performance Study: No. This is not applicable to a physical medical device.

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

Type of Ground Truth: For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, material standards, and verifiable physical measurements. For example, during dimensional analysis, "ground truth" would be the engineering drawings and metrology results. For endotoxin testing, it would be a validated assay and defined pass/fail criteria.

8. The sample size for the training set

Training Set Sample Size: Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would involve specific samples for each test type mentioned.

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

Ground Truth for Training Set Establishment: Not applicable/provided, as there is no "training set."

Summary of Device and Study Context:

This 510(k) submission, K161798 for the FacetBRIDGE® System, is for a line extension (new washer design) to an already cleared device. The regulatory strategy applied here is to demonstrate "substantial equivalence" to a predicate device (K152137), meaning the new design does not introduce new questions of safety or effectiveness. For such a submission, extensive de novo clinical trials are often not required. The clinical performance data section explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." The non-clinical data primarily consists of engineering analysis, functional verification using sawbones, and endotoxin testing, which are standard for changes to mechanical devices to confirm continued safety and performance without needing full clinical re-validation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, suggesting a sense of community and support.

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

August 4, 2016

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

Re: K161798

Trade/Device Name: FacetBRIDGE® System Regulatory Class: Unclassified Product Code: MRW Dated: July 28, 2016 Received: July 29, 2016

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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,

Vincent J. Devlin -S

for

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161798

Device Name FacetBRIDGE® System

Indications for Use (Describe)

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity.

· Spondylolisthesis,

· Spondylolysis.

· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,

· Degeneration of the facets with instability,

· Trauma including spinal fractures and/or dislocations.

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

X 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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for LDR. The logo consists of a stylized eye graphic in light blue, followed by the letters "LDR" in bold, dark blue font. Below the logo, the text "a passion for innovation" is written in a smaller, light blue font.

	510(k) Summary
Owner's Name & Address:	LDR Spine USA, Incorporated13785 Research Blvd. Suite 200Austin, TX 78750
Contact Person:	Mr. Jamie E. WilsonRegulatory Affairs SpecialistPhone: (512) 344-3355Fax: (512) 795-8306Email: jamie.wilson@ldrspine.com
Date:	July 28, 2016
Trade Name:	FacetBRIDGE® System
Common Name:	System, Facet Screw Spinal Device
Panel:	Orthopedic
Product Code:	MRW
Classification:	Unclassified
Predicate Devices:	Primary Predicate:FacetBRIDGE® System – Facet Screws (K152137, LDR Spin1/25/2016)

Device Description:

The FacetBRIDGE® System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion.

Indications for Use:

The LDR FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a logo for LDR. The logo features a stylized eye graphic in light blue, followed by the letters "LDR" in bold, dark blue font. Below the letters, there is a tagline that reads "a passion for innovation" in a smaller, lighter font.

through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The LDR FacetBRIDGE® System is indicated for treatment for any or all of the following:

Pseudoarthrosis and failed previous fusions which are symptomatic or which may ● cause secondary instability or deformity,
Spondylolisthesis, ●
Spondylolysis, ●
o Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
Degeneration of the facets with instability,
o Trauma including spinal fractures and/or dislocations.

Purpose of this submission:

The purpose of this submission is to introduce a line extension which includes an additional washer design for the FacetBRIDGE® System.

Non-Clinical Performance Data:

Non-clinical performance bench testing conducted to support substantial equivalence for the FacetBRIDGE® System included:

Engineering and dimensional analysis
Functional verification study utilizing sawbones. .
o Endotoxin Testing

The results of detailed engineering analyses and functional verifications ensure that the addition of a new washer does not create a new worst case in terms of functionality or mechanical strength and therefore this line extension is substantially equivalent to the predicate system and does not require new testing.

Clinical Performance Data:

Clinical testing was not required to demonstrate substantial equivalence.

Basis of Substantial Equivalence:

The FacetBRIDGE® 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 assessments of these characteristics demonstrate that the subject device is fit for its intended use and comparable to the predicate device. Therefore, the modified FacetBRIDGE® System is overall is substantially equivalent to the predicate FacetBRIDGE® System.

Regulation Number and Section

N/A