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 pseudoarthrosis and/or failed previous fusion between and including levels C2 and C7.

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

Device Description

The Lanx Anterior Cervical Plate System consists of anterior plates and bone screws that are used to build a construct to provide stabilization of the anterior cervical spine to support fusion. The system contains plates and screws of various sizes that allow the surgeon to address single or multi-level cervical spine conditions. The material for components of the Lanx Anterior Cervical Plate System is implant grade titanium alloy (Ti-6Al-4V ELI).

AI/ML Overview

Here's an analysis of the provided text regarding the Lanx Anterior Cervical Plate System's acceptance criteria and study information:

This document is a 510(k) Summary and an FDA clearance letter for a medical device. This type of submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or detailed performance through extensive clinical studies as required for a PMA (Premarket Approval). Therefore, much of the information typically sought for AI/ML device studies (like performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) might not be explicitly detailed, as the regulatory pathway is different.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Performance	`Not explicitly stated beyond "met acceptance criteria"`	"The Lanx Anterior Cervical Plate met the acceptance criteria and functioned as intended." "Mechanical testing also demonstrated comparable mechanical properties to previously cleared devices."
Material Composition	`Not explicitly stated, but implied to be equivalent to predicate`	"Implant grade titanium alloy (Ti-6Al-4V ELI)" (matches common predicate materials)
Functionality	`Implied to provide stabilization and allow fusion`	"functions as intended"
Substantial Equivalence	"As safe and effective as the predicate device"	"The Lanx Anterior Cervical Plate System is as safe and effective as the predicate device." "Same or similar intended use, indications, technological characteristics and principles of operation as the predicate device." "Minor differences... do not raise new issues of safety or effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "Performance testing" and "Mechanical testing," implying the use of physical samples of the device and potentially comparison to predicate devices, rather than a dataset of patient images or clinical outcomes.
Data Provenance: Not applicable in the context of this device clearance. The data provenance would relate to the mechanical testing conducted on the device components themselves.
Retrospective or Prospective: Not applicable. In this context, testing would be conducted on manufactured devices, usually in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. For mechanical performance testing, "ground truth" is typically defined by engineering specifications, material standards, and established testing protocols. Human experts are involved in designing and executing these tests, but not in establishing a "ground truth" in the diagnostic sense.
Qualifications of Experts: Not specified. Presumably, engineers and technicians qualified in biomechanics, materials science, and medical device testing would have been involved.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation (e.g., diagnostic image reading, clinical assessment) where disagreements among readers need to be resolved to establish ground truth. For mechanical testing, results are typically quantitative and objective, measured against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid on human reader performance, typically in imaging applications. The Lanx Anterior Cervical Plate System is an implantable medical device, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This concept applies to AI/ML algorithms. The Lanx Anterior Cervical Plate System is a physical implant, not an algorithm. Performance is assessed through mechanical testing and comparison to a predicate device.

7. The Type of Ground Truth Used

Type of Ground Truth: For the mechanical performance testing, the ground truth would be defined by engineering specifications, material science standards (e.g., ASTM or ISO standards for medical implants), and established biomechanical testing protocols. The "substantial equivalence" ground truth is established by demonstrating that the device performs equivalently to a legally marketed predicate device based on these engineering metrics.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The design of the device is based on established engineering principles and prior research in spinal fixation.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary and Context:

It is crucial to understand that this document describes a 510(k) clearance process for a physical implantable device. The focus of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, primarily through non-clinical (e.g., mechanical) testing and comparison of intended use, technological characteristics, and materials. This is different from the regulatory pathway for AI/ML-driven diagnostic devices or novel therapeutic devices that might require extensive clinical trials and detailed performance metrics as described in the prompt's questions. The information provided in the 510(k) summary is typical for this type of device and regulatory submission.

Summary

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K090316
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510(k) SUMMARY Lanx Anterior Cervical Plate System

Submitter Information

Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 Contact Person: Andrew Lamborne Date Prepared: February 6, 2009

APR - 7 2009

Device Identification

Proprietary Name:	Lanx Anterior Cervical Plate System
Common Name:	Anterior Cervical Plate System
Classification:	Spinal intervertebral body fixation orthosis, 21 CFR 888.3060

Predicate Device Information

Lanx Anterior Cervical Plate System

Intended Use / Indications for Use

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

Technological Characteristics

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Performance Data

Performance testing was conducted to characterize the modified system. The Lanx Anterior Cervical Plate met the acceptance criteria and functioned as intended.

16990316

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Substantial Equivalence

The Lanx Anterior Cervical Plate System is as safe and effective as the predicate device. The Lanx Anterior Cervical Plate System has the same or similar intended use, indications, technological characteristics and principles of operation as the predicate device. The minor differences between the Lanx Anterior Cervical Plate System and its predicate device do not raise new issues of safety or effectiveness. Mechanical testing also demonstrated comparable mechanical properties to previously cleared devices. Thus, the Lanx Anterior Cervical Plate System is substantially equivalent to the predicate device.

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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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The eagle is depicted in black and white, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.

Food and Drug Administration

9200 Corporate Boulevard

Public Health Service

Rockville MD 20850

Lanx, Inc. % Mr. Andrew Lamborne 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

APR - 7 2009

Re: K090316

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: March 9, 2009 Received: March 10, 2009

Dear Mr. Lamborne:

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 - Mr. Andrew Lamborne

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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson for mom

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

Enclosure

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K090316
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Indications for Use Statement

510(k) Number (if known):

1090316

Device Name: Lanx Anterior Cervical Plate System

Indications for Use:

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 levels C2 and C7.

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aboulina Onuchm
(Division Sign-Off) for WM
Page _ of _

Division of General, Restorative, and Neurological Devices

510(k) Number 1<0903/6

Regulation Number and Section

N/A