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, 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 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

This document is a 510(k) summary for a medical device called Lucent®, an intervertebral body fusion device.

Here's an analysis of the provided text in the context of your request:

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

The document does not provide acceptance criteria or reported device performance in the typical sense of quantitative metrics for a study. This 510(k) pertains to line additions to an already cleared device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria.

The "Performance Data" section explicitly states: "No clinical testing was found to be necessary. Given the type of changes made to the Lucent device, no additional non-clinical testing was required or performed."

Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

As stated above, no new performance data or clinical testing was conducted for this 510(k) submission. The device's substantial equivalence is based on its similarity to previously cleared devices. Therefore, there is no test set sample size or data provenance to report from this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Since no new performance data or clinical testing was performed, there was no test set for which ground truth needed to be established by experts.

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

Not applicable, as no test set was used for new performance evaluation.

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 is an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no new performance validation using a specific ground truth was conducted. The ground for substantial equivalence relies on comparison of design, materials, and indications for use with predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of Device Acceptance and Study proving criteria:

The document describes the device, Lucent®, as an intervertebral body fusion device. This 510(k) submission is for line additions to an already cleared device. The primary method of demonstrating acceptance and meeting criteria is through substantial equivalence to legally marketed predicate devices.

The study that "proves" the device meets acceptance criteria, in this context, is the comparison to predicate devices. The submission argues that:

The subject device is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in K122967 and K150061.
It has equivalent technological characteristics to its predicates in areas including labeling/indications for use, general design features, function, material, manufacturing process, and instrumentation.

Therefore, the "proof" is based on the argument that because the device is sufficiently similar to devices already found safe and effective, no new performance studies are required.

Summary

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November 29, 2017

Spinal Elements, Inc. Julie Lamothe, Ph.D., MBA Regulatory Affairs & Quality Assurance Director 3115 Melrose Dr., Suite 200 Carlsbad, California 92010

Re: K170235

Trade/Device Name: Lucent® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 3, 2017 Received: November 6, 2017

Dear Julie 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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,

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

510(k) Number (if known) K170235

Device Name Lucent®

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®

510(k) Number: K170235

Manufacturer Identification
Submitted by:	Spinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010P. 760-607-0121F. 760-607-0125
Contact Information:	Julie Lamothe, Ph.D., MBARegulatory Affairs & Quality Assurance DirectorSpinal Elements, Inc.3115 Melrose Dr., Suite 200Carlsbad, CA 92010760-607-1816jlamothe@spinalelements.com
Date Prepared:	November 20, 2016
Proprietary Name	Lucent®
Device Classification	21 CFR 888.3080 (Intervertebral BodyFusion Device)
Proposed Regulatory Class	Class II
Device Product Code	MAX

Purpose of this 510(k)

This 510(k) seeks clearance for line additions to the Lucent® previously cleared for use under K122967 and K150061, respectively.

Device Description

Indications for Use

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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).

Substantial Equivalence

The subject device is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in K122967 and K150061.

Technological Characteristics

The subject device has equivalent technological characteristics to its predicates presented below through comparison in areas including labeling/indications for use, general design features, function, material, manufacturing process and instrumentation:

Spinal Elements Lucent Interbody Device K150061 Primary ●
Spinal Elements Lucent Interbody Device K122967 Additional Predicate ●
LANX, Inc. Lanx Lateral Device K103666 Additional Predicate ●
DePuy Spine, Inc. COUGAR® LS Lateral Cage Device K162327 Additional . Predicate

Performance Data

No clinical testing was found to be necessary. Given the type of changes made to the Lucent device, no additional non-clinical testing was required or performed.

Materials and Standards

The previously cleared devices and the devices submitted herein may be manufactured from titanium (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3. polyetheretherketone (PEEK-Optima® provided by Invibio grade LT1) materials or polyetheretherketone (PEEK-Optima® provided by Invibio grade LT1) with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces. 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.

Conclusion

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.