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 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.

Device Description

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as an interbody device or interbody cage. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. The exterior of the devices have "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are surgically positioned.

The devices submitted herein may be manufactured from polyetheretherketone (PEEK) materials and titanium alloy (Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472) or PEEK material conforming to ASTM F 2026 with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces and titanium alloy (Ti-6Al-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472). Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are placed in various locations of the PEEK devices to serve as markers for radiographic visualization of device orientation.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called Lucent® XP Curved, an intervertebral body fusion device.

Based on the provided text, the device does not involve an AI/ML component or complex diagnostic performance. Therefore, a study demonstrating the device meets acceptance criteria related to AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop improvement, ground truth methodology) is NOT applicable here.

The acceptance criteria and supporting "study" are primarily focused on mechanical performance and material characteristics to demonstrate substantial equivalence to a previously cleared predicate device.

Here's a breakdown of the relevant information provided:

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

The document states: "All data indicates that the device will perform as intended." The "acceptance criteria" are implied by adherence to the referenced ASTM standards and the demonstration of "substantial equivalence" to the predicate. No numerical performance metrics are provided in a table format in this document, as the focus is on similarity to an already cleared device, not novel performance claims.

Acceptance Criteria (Implied)	Reported Device Performance
Static Compression Testing per ASTM F 2077-18: Performance comparable to predicate.	Performed; "All data indicates that the device will perform as intended."
Dynamic Compression Testing per ASTM F 2077-18: Performance comparable to predicate.	Performed; "All data indicates that the device will perform as intended."
Static Compression Shear Testing per ASTM F 2077-18: Performance comparable to predicate.	Performed; "All data indicates that the device will perform as intended."
Dynamic Compression Shear Testing per ASTM F 2077-18: Performance comparable to predicate.	Performed; "All data indicates that the device will perform as intended."
Biocompatibility: Identical materials and manufacturing to predicate.	Biocompatibility testing not required as materials and processes are identical to previously cleared K182584.
Electrical safety and electromagnetic compatibility (EMC): Not applicable for this type of device.	No electrical and electromagnetic compatibility testing were performed.
Software Verification and Validation Testing: No software in the device.	No software verification and validation testing were performed.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated as a number of 'cases' or 'patients'. The testing is mechanical (on the device itself) rather than clinical. The "sample" would refer to the number of devices or test coupons subjected to the specified ASTM mechanical tests. This information is typically detailed in the full test reports, not usually summarized in this 510(k) format.
Data Provenance: The document does not specify country of origin for the mechanical testing data. It is inherently "retrospective" in the sense that the justification relies on the established performance of the predicate device.

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

Not Applicable. This is a mechanical device, not one requiring expert human interpretation of medical images or data for ground truth establishment. The "ground truth" for this device's performance is objective mechanical testing per engineering standards (ASTM F 2077-18).

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

Not Applicable. As no expert review or human interpretation is involved in establishing performance, no adjudication method is necessary.

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:

Not Applicable. This device does not involve AI or human readers for diagnostic assistance.

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

Not Applicable. This device does not have a software algorithm component.

7. The type of ground truth used:

For mechanical performance: Objective engineering standards and test results from the ASTM F 2077-18 standards.
For biocompatibility: Identity to previously cleared materials and manufacturing processes from predicate device K182584.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this device does not utilize machine learning or AI.

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

Not Applicable. As there is no training set.

Summary

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December 22, 2020

Spinal Elements, Inc. Julie Lamothe, Ph.D., MBA Vice President of Regulatory Affairs 3115 Melrose Dr. Suite 200 Carlsbad, California 92010

Re: K202298

Trade/Device Name: Lucent® XP, Lucent® XP Curved Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 20, 2020 Received: November 25, 2020

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. 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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202298

Device Name Lucent® XP Curved

Indications for Use (Describe)

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)

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510(k) Summary Lucent® XP Curved

510(k) Number: K202298

I. SUBMITTER	Spinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010P. 760-607-0121F. 760-607-0125
Contact Information:	Julie LamotheSpinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-1816jlamothe@spinalelements.com
Date Prepared:	August 11, 2020
II. DEVICE
Proprietary Name	Lucent® XP Curved
Regulation 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 a line addition to Spinal Elements' Lucent XP intervertebral body fusion devices previously cleared under K182584. The additional sizes have identical indication for use and fundamental scientific technology as the predicate.

IV. DEVICE DESCRIPTION

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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).

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 (K182584): Primary Predicate

Lucent® devices (K071724): Additional Predicate

Lucent® devices (K113527): 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 K182584. The subject devices include additional sizes to the Lucent® XP devices. 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 K182584. 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.

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

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identified in previously cleared K182584 Lucent XP® submission. Biocompatibility testing is not 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

The subject device has the same performance characteristics as the previously cleared predicate device K182584. 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 Compression Testing per ASTM F 2077-18
Dynamic Compression Testing per ASTM F 2077-18 ●
. Static Compression Shear Testing per ASTM F 2077-18
Dynamic Compression Shear Testing per ASTM F 2077-18

All data indicates that the device will perform as intended.

Animal Study

No animal studies were performed.

Clinical Studies

No clinical studies were performed.

VIII. 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.