When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device:

When used as an intervertebral body fusion device, the Lucent Magnum device is 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 of non-operative treatment prior to being treated with the Lucent Magnum device.

Device Description

Spinal Elements' Lucent Magnum device is a generally oval-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces.

The device body may be made from titanium alloy (Ti-6A1-4V) or polyetheretherketone (PEEK).

Devices are available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient.

AI/ML Overview

The Lucent® Magnum device is a medical implant, and its acceptance criteria are based on mechanical performance demonstrating substantial equivalence to predicate devices, rather than a clinical study with human readers or AI.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance	"Mechanical testing indicates that the Lucent Magnum device is capable of performing in accordance with its intended use."
Substantial Equivalence to Predicate Devices	"The Lucent Magnum device was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices."

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

Sample Size: Not applicable. The "study" referenced is mechanical testing, not a clinical trial with a test set of patient data.
Data Provenance: Not applicable.

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

Not applicable as the assessment is based on mechanical testing and comparison to predicate devices, not expert human interpretation of medical data.

4. Adjudication method for the test set:

Not applicable.

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:

No MRMC study was performed or is relevant to this device. This device is an implant, not an AI-powered diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the Lucent® Magnum's acceptance is based on established engineering principles and benchmarks for mechanical strength and durability of similar intervertebral body fusion devices, as demonstrated through mechanical testing. The comparison against legally marketed predicate devices serves as the standard for substantial equivalence.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

Summary

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Special 510(k) Summary Lucent® Magnum

510(k) Number _Ko 73348

Manufacturer IdentificationSubmitted by:	Spinal Elements, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92010760-607-0121DEC 2 6 2007
Contact Information:	Kerri DiMartinoRegulatory Affairs SpecialistSpinal Elements, Inc.2744 Loker Ave. W., Suite 100Carlsbad, CA 92010760-607-1816kdimartino@spinalelements.com
Date Prepared:	December 21, 2007
Device IndentificationProprietary Name:Common Name:	Lucent® MagnumIntervertebral Body Fusion Device;Vertebral Body Replacement
Device Classification:	21 CFR 888.3080 (orthosis, spinal intervertebralfusion); 21CFR 888.3060 (spinal intervertebral bodyfixation orthosis)

Device Description

Spinal Elements' Lucent Magnum device is a generally oval-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces.

The device body may be made from titanium alloy (Ti-6A1-4V) or polyetheretherketone (PEEK).

Devices are available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient.

Intended Use of the Device

When used as a vertebral body replacement:

When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged,

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K073348

Page 2 of 2

or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

When used as an intervertebral body fusion device:

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent Magnum device.

Substantial Equivalence

The Lucent Magnum device was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices.

Performance Data

Mechanical testing indicates that the Lucent Magnum device is capable of performing in accordance with its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 6 2007

Spinal Elements, Inc. % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue W., Suite 100 Carlsbad, CA 92010

Re: K073348

Trade/Device Name: Lucent® Magnum Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 24, 2007 Received: December 29, 2007

Dear Ms. DiMartino:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Kerri DiMartino

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K. 073348

Device Name: Lucent® Magnum

Indications for Use:

When used as a vertebral body replacement:

When used as an intervertebral body fusion device:

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent device.

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

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)
Division of General, Restorative
and Neurological Devices

510(k) Number	K073346
	Page 1 of 1

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.