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).

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).

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

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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. 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) summary for the Lucent® XP intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and non-clinical testing. It explicitly states that no acceptance criteria or studies proving device performance against such criteria are presented in this document.

The document details the following about the device's evaluation:

Acceptance Criteria and Reported Device Performance:
- No specific acceptance criteria (e.g., in terms of clinical outcomes, accuracy, or specific performance metrics) are mentioned in this 510(k) summary.
- The document states: "All data indicates that the device will perform as intended." This is a general statement and not a specific performance metric against a defined acceptance criterion.
Sample Size used for the test set and the data provenance:
- No clinical or standalone performance test sets are mentioned. The "non-clinical testing" refers to mechanical tests of the device itself (hardware). The sample sizes for these mechanical tests are not provided.
- Data provenance is not applicable as no clinical or image-based studies are referenced.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no expert-reviewed test sets (e.g., for image interpretation or diagnosis) were used. The evaluation was based on mechanical testing of the physical device.
Adjudication method for the test set:
- Not applicable, as no expert-reviewed test sets were used.
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 MRMC or human-in-the-loop studies were performed. The device is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the engineering specifications and recognized industry standards (ASTM F 2077-14) against which the device performance was measured.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of Device Evaluation (based on the provided text):

The evaluation for the Lucent® XP intervertebral body fusion device primarily relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies or performance against specific acceptance criteria.

Mechanical Testing:
- Performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device."
- Included:
  - Static and Dynamic Compression Testing per ASTM F 2077-14
  - Static and Dynamic Compression Shear Testing per ASTM F 2077-14
- The document states: "All data indicates that the device will perform as intended."
Biocompatibility Testing: The materials and manufacturing processes were stated to be identical to previously cleared devices (K152011), thus no new biocompatibility testing was reported.
No Electrical Safety, Software Verification, Animal Studies, or Clinical Studies were performed.

Summary

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December 10, 2018

Image /page/0/Picture/11 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spinal Elements, Inc. Ms. Cheryl Allen Regulatory Affairs Manager 3115 Melrose Dr., Suite 200 Carlsbad, California 92010

Re: K182584

Trade/Device Name: Lucent® XP Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 20, 2018 Received: September 21, 2018

Dear Ms. Allen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -S

For 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) K182584

Device Name Lucent® XP

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)

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510(k) Summary Lucent® XP

510(k) Number K182584

I. SUBMITTER

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

Contact Information:	Cheryl Allen
	Regulatory Affairs Manager
	Spinal Elements, Inc.
	3115 Melrose Dr., Suite 200
	Carlsbad, CA 92010
	760-607-1840
	callen@spinalelements.com

Date Prepared:	October 29, 2018
----------------	------------------

II. DEVICE
Proprietary Name	Lucent® XP
Common Name	Intervertebral Body Fusion Device
Device Classification	21 CFR 888.3080 (Appliance, Fixation SpinalIntervertebral Body)
Proposed Regulatory Class	Class II
Device Product Code	MAX

III. Purpose of this 510k

This Traditional 510(k) seeks clearance for minor modifications to Lucent® XP intervertebral body fusion devices previously cleared under K152011 (10mm footprint), additional sizes (12mm footprint) and an expanded indication for all devices cleared under K152011 to include the use of allogenic bone graft comprised of cancellous and/ or corticancellous bone graft. The new devices have an identical intended use and fundamental scientific technology as the predicate.

IV.DEVICE DESCRIPTION

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engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

V. INDICATIONS FOR USE

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 autograph or allogenic bone graft comprised of cancellous and/or corticancellous 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. SUBSTANTIAL EQUIVALENCE

The subject devices are substantially equivalent in indications for use, surgical technique, design features, manufacturing methods and raw materials to the following predicate devices:

Lucent® devices (K152011): Primary Predicate Lucent® devices (K110632): Additional Predicate Lucent® devices (K170235): Additional Predicate

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is identical in manufacturing method, raw material, basic operating principles and fundamental scientific technology to the predicate devices cleared in K152011. The subject devices include modifications to the existing 10mm footprint devices and additional sizes to the Lucent® XP devices. The subject device is seeking clearance for expanded indications for use to include autograph or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. The subject device indications for use are identical to the indications for use as the additional predicate cleared in K170235. The devices will be marketed sterile and non-sterile. The specifications and manufacturing of the titanium coating is identical to that of the predicate devices cleared in K152011. The devices will be marketed with and without a plasma-sprayed porous titanium surface. The modifications do not raise any new issues of safety or effectiveness when compared to the predicate devices.

VIII. PERFORMANCE DATA Biocompatibility Testing

The materials used to manufacture the subject devices as well as the manufacturing processes for the devices seeking clearance are identical as the materials and processes identified in previously cleared K152011 Lucent XP® submission.

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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

The subject device has the same performance characteristics as the previously cleared predicate device K152011. Non-clinical testing was used to support the decision of substantial equivalence. Non-clinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:

Static and Dynamic Compression Testing per ASTM F 2077-14
Static and Dynamic Compression Shear Testing per ASTM F 2077-14 o

All data indicates that the device will perform as intended.

Animal Study

No animal studies were performed.

Clinical Studies

No clinical studies were performed.

VIIII. CONCLUSIONS

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.

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.