The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including cervical levels C2 and C7.

Device Description

Materials for components of the Lanx Anterior Cervical Plate System are implant grade materials of titanium. The materials comply with applicable standards shown below. The system components include: Instruments, Sterilizer trays, Locking caps, Cervical Plates (One Level, Two Level, Three Level, Four Level, Five Level), Bone Screws - Fixed (4.0mm Self Drilling, Self Tapping, 4.5mm Self Drilling, Self Tapping), Bone Screws - Variable (4.0mm Self Drilling, Self Tapping, 4.5mm Self Drilling, Self Tapping).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Lanx Anterior Cervical Plate System) and focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the results of a primary clinical study for novel performance claims.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not directly available in this type of submission. This document highlights mechanical and material testing to ensure safety and equivalence, but not clinical performance in the sense of accuracy, sensitivity, or specificity.

Here's the information that can be extracted or reasonably inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion	Acceptance Criteria (Inferred from Equivalence)	Reported Device Performance/Comparison (Lanx Anterior Cervical Plate System)
Indications for Use	Temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease, trauma, tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including cervical levels C2 and C7.	SAME as predicate device (Atlantis Anterior Cervical Plate System).
Design	Anatomically curved metallic plate.	SAME as predicate device.
Sterility	Not sterile, must be autoclaved.	SAME as predicate device. Recommended sterilization: high-temperature steam autoclave, producing SAL of at least 10^-6. Validated cycle: Steam (Gravity), 270°F (134°C) for 30 minutes.
Plate Sizes	Equivalent range of plate sizes for 1-level to 5-level fixation (e.g., 18mm - 118mm length in 2-5mm increments).	EQUIVALENT to predicate device.
Screw Sizes	Equivalent range of screw sizes (e.g., 4mm & 4.5mm diameter, 10-25mm length in 1mm increments).	EQUIVALENT to predicate device.
Material	Titanium and Titanium Alloy (specifically ASTM F136-92/ISO 5832-3 for Titanium Alloy, ASTM F67 GR2-95/ISO 5832-2 for Titanium).	SAME as predicate device. Materials comply with applicable standards.
Mechanical Performance	Equivalent fatigue and static strength performance to existing anterior cervical plate systems, as demonstrated through engineering and scientific principles. No specific numerical thresholds are provided, but the claim is equivalence.	Fatigue and static testing of individual components and typical system configurations were conducted. "Test results demonstrate that the Lanx Anterior Cervical Plate System performs in a manner equivalent to other existing anterior cervical plate systems." (No specific numerical results reported in this summary).
Compliance with Standards	Adherence to "various voluntary performance standards" including ASTM, Standard Operating Procedures, vendor & process certification, Quality Systems Regulations, ISO materials standards, ISO 9000 series. Comply with general controls under the Food, Drug, and Cosmetic Act.	Voluntary standards utilized. Meets appropriate general controls.

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

Test Set Sample Size: Not applicable in the context of clinical performance or diagnostic accuracy. The testing described is primarily mechanical/material performance testing (fatigue and static testing). The number of samples for these engineering tests is not specified in this summary.
Data Provenance: Not applicable for clinical data. For the described mechanical testing, the data would have been generated internally by Lanx, LLC or their chosen testing facilities.

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

Not applicable. This submission does not involve clinical data with "ground truth" established by human experts. The "ground truth" for mechanical testing would be defined by the specifications and standards (e.g., ASTM F136-92 for material strength, established mechanical testing protocols).

4. Adjudication method for the test set:

Not applicable. This concept applies to human reader studies or clinical trials, which are not detailed in this 510(k) summary for this device.

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 implantable medical device (anterior cervical plate system), not a diagnostic or AI-assisted device. Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is relevant or discussed.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

For the mechanical and material characteristics, the "ground truth" is defined by established engineering standards and specifications (e.g., ASTM F136-92, ISO 5832-3 for materials, and "accepted engineering and scientific principals" for fatigue and static testing).
For the claim of substantial equivalence, the "ground truth" is the characteristics and performance of the predicate device (K993855, Atlantis Anterior Cervical Plate System), as documented in its own clearance and publicly available information.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this device; it is not an AI/machine learning device.

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

Not applicable.

In summary, this 510(k) premarket notification demonstrates substantial equivalence primarily through comparison to a predicate device and mechanical/material testing against recognized industry standards, rather than clinical efficacy trials involving human subjects or advanced diagnostic performance metrics.

Summary

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KD40401

APR 1 2 2004

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Section 510(k)" Premarket Notification __Advanced the charles for the first of the first of the program promotion		FEBRUARY 12 2004

Requlatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Lanx Anterior Cervical Plate System Trade Name:

Common

Anterior cervical spine system Name(s):

Classification

Spinal intervertebral body fixation orthosis. Name(s):

2. Establishment Name & Registration Number:

Name:	LANX, LLC.
Number:	Pending

3. Classification(s):

& 888,3060 Spinal intervertebral body fixation orthosis. (a) Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eyetvpe screw. The cable is tightened with a tension device and it is fastened or crimped at each evetype screw. The device is used to apply force to a series of vertebrae to correct "sway back", scoliosis (lateral curvature of the spine), or other conditions. (b) Classification. Class II.

Device Class: Class II for all requested indications Classification Panel: Orthopaedic and Rehabilitation Devices Panel Product Code(s): KWQ

4. Equivalent Predicate Device:

LANX, LLC. believes that the Lanx Anterior Cervical Plate System is substantially equivalent to the following device system marketed by Sofamor/Danek of Memphis TN.

K993855, Atlantis Anterior Cervical Plate System, Sofamor/Danek.

The Sofamor/Danek brand cervical plates are cleared for marketing. The comparison device represents a cervical spinal instrumentation system and accessories that uses plates, screws, and other corresponding components, all of which are intended to be used for the surgical treatment of cervical spinal instability or deformity. Equivalence can be seen in the design, material composition, surgical technique and intended use.

Device Description: 5.

General system description.

Materials. Materials for components of the Lanx Anterior Cervical Plate System are implant grade materials of titanium. The materials comply with applicable standards shown below.

Titanium Alloy	ASTM F136-92	ISO 5832-3
Titanium	ASTM F67 GR2-95	ISO 5832-2

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The system components include:

Instruments

Sterilizer trays

Locking caps

Cervical Plates One Level Two Level Three Level Four Level Five Level

Bone Screws - Fixed 4.0mm Self Drilling, Self Tapping 4.5mm Self Drilling, Self Tapping

Bone Screws - Variable

4.0mm Self Drilling, Self Tapping 4.5mm Self Drilling, Self Tapping

Testing Summary. Fatigue and static testing of individual components as well as a typical system configuration were conducted. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the Lanx Anterior Cervical Plate System performs in a manner equivalent to other existing anterior cervical plate systems.

Applicant Name & Address: 6.

Lanx, LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: 303-443-7501 fulton@lanx.us

7. Company Contact:

Michael Fulton, M.D. Lanx, LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: 303-443-7501 fulton@lanx.us

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 9.25.356.2640 - 925.356.2654 - fax

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K040401

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

LANX, LLC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

10. Special Controls:

Special controls do not apply.

11. Storage, Packaging & Sterilization Information:

The Lanx Anterior Cervical Plate System is supplied "NON-STERILE" and must be sterilized prior to use. The recommended sterilization process is high temperature steam autoclaye sterilization. The referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 10 €.

The validated cycle is:

Miethod: Steam Cycle: Gravity Temperature: 270°F (134°C) Exposure Time: 30 minutes

All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned.

Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

12. Summary Comparison Table:

FEATURE	Lanx Anterior Cervical Plate System	Atlantis Anterior Cervical Plates.	SE?
Indications forUse:	Temporary stabilization of the anterior spine while awaitingbony fusion (healing) in patients with degenerative discdisease (neck or radicular pain of discogenic origin withdegeneration of the disc confirmed by patient history andradiographic studies), trauma (including fractures), tumors,deformity(kyphosis,lordosisorscoliosis),orpseudoarthrosis and/or failed previous fusion.	SAME	YES
Design:	Anatomically curved metallic plate	SAME	YES
Sterile:	No - Must be Autoclaved	SAME	YES
Plate Sizes:	1-level to 5-level18mm - 118mm length in 2-5mm increments	EQUIVALENT	YES
Screw Sizes:	4mm & 4.5mm dia. 10-25mm length in 1 mm increments	EQUIVALENT	YES
Material:	Titanium and Titanium Alloy	SAME	YES
Origin:	USA	USA	YES
Manufacturer:	Lanx, LLC	Sofamor/Danek	YES
Product Code:	KWQ	SAME	YES
K - Number:	Pending	K993855	YES

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings or feathers. The eagle is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Lanx, LLC C/o David W. Schlerf Buckman Company Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill. California 94523-3389

Re: K040401

Trade/Device Name: Lanx Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 12, 2004 Received: February 17, 2004

Dear Mr. Schlerf:

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 cnactment 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 -- David W. Schlerf

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

O Mula A. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K040401 510(k) Number :

Device Name(s): Lanx Anterior Cervical Plate System

Indications For Use:

Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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 Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number K040401

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.