Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

These devices are intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with these devices.

Device Description

The Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the LUCENT® and LUCENT Ti-BOND® intervertebral body fusion devices. It is a submission to the FDA seeking clearance to market a medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., a specific strength value that must be met). Instead, it relies on demonstrating that the device performs comparably to predicate devices under a set of established tests.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:	Demonstrated the PEEK material's biocompatibility via Invibio device master file (MAF 1209) and the titanium coating material's biocompatibility by reference to ASTM F 1580. No further testing was required.
Mechanical Strength (Static Compression):	Testing performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." The document implies the device met the requirements of this guidance, performing comparably to the predicate device.
Mechanical Strength (Dynamic Compression):	Testing performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." The document implies the device met the requirements of this guidance, performing comparably to the predicate device.
Substantial Equivalence to Predicate Devices:	The submitter concludes, "Based on our analysis of the test data, the device performs comparably to the predicate device that is currently marketed for the same intended use." This is the overarching "acceptance criterion" for a 510(k) submission.
No New Safety/Effectiveness Issues from Modifications:	The document states, "Neither modification raises any new issues of safety or effectiveness." This refers to the introduction of a rounded anterior end and additional line item configurations in the Lucent line.
Electrical Safety and EMC:	Not applicable; "No electrical and electromagnetic compatibility testing were performed."
Software Verification and Validation:	Not applicable; "The device does not contain software. Therefore no software verification and validation testing were performed."
Animal Study:	Not applicable; "No animal studies were performed."
Clinical Studies:	Not applicable; "No clinical studies were performed."
Compliance with General Controls (e.g., GMP, Labeling):	The FDA letter explicitly notes that the substantial equivalence determination does not mean the device complies with other requirements of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling). These are implicit ongoing requirements for market acceptance.

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

Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests (Static Compression and Dynamic Compression). It simply states that "Non-clinical testing were used," and lists the types of tests.
Data Provenance: The document does not provide details about the country of origin for the data or whether it was retrospective or prospective. Given that no animal or clinical studies were performed, the "data" primarily refers to the results of the benchtop mechanical, biocompatibility, and material characterization tests.

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

This information is not applicable in the context of this 510(k) submission for these types of mechanical and biocompatibility tests. "Ground truth" for mechanical testing is established by engineering standards and validated testing protocols. For biocompatibility, it's established by recognized standards (e.g., ISO 10993-1) and material master files. There's no mention of experts establishing ground truth in the way it would be for, say, a diagnostic imaging study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human readers or evaluators make subjective assessments that need to be reconciled, such as in clinical trials or AI performance evaluations involving expert consensus. This document describes benchtop mechanical and material tests, which rely on objective measurements and adherence to standards rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm. The document explicitly states: "The device does not contain software. Therefore no software verification and validation testing were performed."

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is adherence to established engineering standards and regulatory guidance. The document states that testing was performed "in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This guidance document would define acceptable ranges or performance attributes that the device must meet to demonstrate safety and effectiveness comparable to predicate devices.

For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1) and material master files (e.g., Invibio device master file MAF 1209, ASTM F 1580 for titanium).

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device (intervertebral body fusion device) without software or AI components, there is no "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above (no training set for a physical device).

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

May 19, 2015

Spinal Elements, Incorporated Julie Lamothe, Ph.D., M.B.A. Regulatory Affairs and Quality Assurance Director 3115 Melrose Drive, Suite 200 Carlsbad, California 92010

Re: K150061

Trade/Device Name: LUCENT®, LUCENT Ti-BOND® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 16, 2015 Received: March 18, 2015

Dear Dr. Lamothe:

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

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

Page 2 - Dr. Julie Lamothe

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/Resourcesfor You/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 vours.

Lori A. Wiggins -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) K150061

Device Name LUCENT®, LUCENT TI-BOND®

Indications for Use (Describe)

These devices are intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with these devices.

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}------------------------------------------------

Premarket Notification –Lucent® Intervertebral Body Fusion Device

510(k) Summary Lucent® and Lucent Ti-Bond®

510(k) Number: K150061

I. SUBMITTER

Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 P. 760-607-0121 F. 760-607-0125

Contact Information:	Julie LamotheDirector Regulatory AffairsSpinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-1816jlamothe@spinalelements.com
----------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Date Prepared:

January 12th, 2015

II. DEVICE

Proprietary Name	Lucent®; Lucent Ti-Bond®
Common Name	Intervertebral Body Fusion Device
Device Classification	21 CFR 888.3080 (Appliance, Fixation Spinal
	Intervertebral Body)
Proposed Regulatory Class	Class II
Device Product Code	MAX

III. PREDICATE DEVICE

Primary Predicate Name	Lucent®
Regulatory Class	Class II
Submission No	K071724
Device Code	MAX
Predicate Name	Lucent Ti-Bond®
Regulatory Class	Class II
Submission No	K110632
Device Code	MAX

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

Predicate Name	Lucent® Lateral
Regulatory Class	Class II
Submission No	K122967
Device Code	MAX

IV. DEVICE DESCRIPTION

V. INDICATION FOR USE

Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is identical in indications for use, surgical technique, manufacturing method, raw material and instrumentation to the predicate devices cleared in K071724. K110632 and K122967. The difference to the Lucent device is the introduction of a rounded anterior end. The devices will be marketed with and without a plasma-spraved porous titanium surface. The specifications and manufacturing of the titanium coating is identical to that of the predicate devices cleared in K110632 and K122967. In addition, line item configurations have been added to the Lucent line. These sizes do not constitute a smaller or larger footprint than the devices cleared in K110632 and K122967. Neither modification raises any new issues of safety or effectiveness.

{5}------------------------------------------------

VII. PERFORMANCE DATA

Biocompatibility Testing

Biocompatibility testing were performed in accordance with FDA Memorandum #G95-1 and ISO 10993-1 Part 1. The Lucent devices are considered permanent implant devices contacting tissue/bone. The PEEK material biocompatibility relevant to the device contact type is presented in Invibio device master file (MAF 1209). The titanium coating material is commercially pure titanium. The coating is in accordance with ASTMF 1580. which address the biocompatibility of the material. No further testing were required.

Electrical safety and electromagnetic compatibility (EMC)

No electrical and electromagnetic compatibility testing were performed.

Software Verification and Validation Testing

The device does not contain software. Therefore no software verification and validation testing were performed.

Mechanical testing

Non-clinical testing were used to support the decision of substantial equivalence. Nonclinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:

. Static Compression
. Dynamic Compression

Animal Study

No animal studies were performed.

Clinical Studies

No clinical studies were performed.

VII. CONCLUSIONS

Based on our analysis of the test data, the device performs comparably to the predicate device that is currently marketed for the same intended use.

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.