Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) 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.

Device Description

This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, 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. This modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment, which are typical for studies validating AI/ML models or novel devices requiring extensive clinical data, is not directly applicable in the context of this 510(k) submission.

Here's an explanation based on the provided document and why most of your requested fields cannot be filled:

Nature of the Device: The Lucent® and Lucent Magnum® are physical intervertebral body fusion devices, not AI/ML systems or diagnostic tools. Their performance is assessed through mechanical testing against established ASTM standards and comparison to predicate devices, not through clinical studies with "test sets," "ground truth experts," or "AI assistance effect sizes."
510(k) Process: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predecessor. The primary method for proving this "substantial equivalence" is through comparison of material specifications, design features, intended use, and performance data (often mechanical testing for implants) against predicate devices. Clinical efficacy studies as you've described for AI models are generally not required for 510(k)s unless the device raises new safety or effectiveness questions not addressed by predicates.

Therefore, many of your specific questions are not addressed in this type of regulatory document. I will fill in what can be inferred or directly stated from the text.

Acceptance Criteria and Device Performance (for a physical medical device)

The "acceptance criteria" for this device are implicitly tied to demonstrating performance at least as good as the predicate devices, as measured by standard mechanical tests. The "reported device performance" is a statement that the device did meet these criteria.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical performance at least as good as previously cleared Lucent system devices (K071724 and K073348) according to ASTM F2077, ASTM F2267, ASTM F1877, ASTM F2025-06.	"A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device."
Coating characteristics meeting standards set by ASTM F1044 and ASTM F1147.	"Coating Characterization testing was performed using coupons... All data indicates that the device will perform as intended."

Study Details and Ground Truth Establishment

Given the nature of a 510(k) for a physical implant, the following information is not applicable or not provided in the document as it would be for an AI/ML diagnostic device study:

Sample size for the test set: Not applicable. Performance was assessed through mechanical testing of the device itself and components, not a "test set" of clinical cases.
Data provenance: Not applicable. Mechanical test results do not have "provenance" in the sense of clinical data (country or retrospective/prospective).
Number of experts used to establish the ground truth for the test set & qualifications: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology). The "ground truth" for mechanical performance is defined by the ASTM standards and the performance of the predicate device.
Sample size for the training set: Not applicable. This is a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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Spinal Elements, Inc. Premarket Notification - Lucent" Intervertebral Body Fusion Device

510(k) Summary Lucent® and Lucent Magnum®

510(k) Number K110632

MAY 2 3 2012

Manufacturer Identification
Submitted by:	Spinal Elements, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92010760-607-0121
Contact Information:	Benjamin A. KimballRegulatory Affairs ManagerSpinal Elements, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92010760-607-1816Bkimball@spinalelements.com
Date Prepared:	March 03, 2011
Proprietary Name	Lucent® and Lucent Magnum®
Common Name	Intervertebral Body Fusion Device
Device Classification	21 CFR 888.3080 (Intervertebral Body Fusion Device
Proposed Regulatory Class	Class II
Device Product Code	MAX

Purpose of this Special 510(k)

This Special 510(k) seeks clearance for a modification to a current system.

Device Description

Intended Use of the Device

Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) in skeletally mature patients

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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 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 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.

Predicates

The Lucent intervertebral body fusion device is substantially equivalent to the following cleared devices in indications for use, design, function, and materials used.

Lucent 510(k) K071724 and K073348
X-Spine Calix PC System (K112036)

Performance Data

A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device.

Testing performed includes:

Static Compression Testing as per ASTM F2077 .
. Static Torsion Testing as per ASTM F2077
. Static Compression-Shear Testing as per ASTM F2077
Dynamic Compression Testing as per ASTM 2077 .
Subsidence Testing as per ASTM F2267 ●
. Wear Characterization as per ASTM F1877, ASTM F2025-06

Coating Characterization testing was performed using coupons.

Coating Characterization -Static and Dynamic Shear per ASTM F1044 .
Coating Characterization Static Tension per ASTM F1147 .

All data indicates that the device will perform as intended.

Substantial Equivalence

The Lucent intervertebral body fusion device was shown to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used.

Lucent 510(k) K071724 and K073348
X-Spine Calix PC System (K112036)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

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

Spinal Elements Inc. % Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Ave. W., Suite 100 Carlsbad, California 92010

MAY 2 3 2012

Re: K110632

Trade/Device Name: Lucent® and Lucent Magnum® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 14, 2012 Received: May 15, 2012

Dear Mr. Kimball:

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

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Page 2 - Mr. Kimball

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) K: 110632

Device Name: Lucent®

Indications for Use:

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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Diysson of Surgical, Orthopedic, and Restorative Devices

510(k) Number ..

KII0632

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.