The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

The Lanx SFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

Device Description

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

AI/ML Overview

The provided text describes the Lanx Spinal Fixation System, a medical device for spinal stabilization. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic AI/ML device.

This document is a 510(k) summary for a physical medical implant (spinal fixation system), not a software or AI/ML diagnostic device. Therefore, the questions related to "acceptance criteria" and "performance studies" would be interpreted differently than for an AI/ML product. For a physical device like this, performance is typically demonstrated through engineering analyses and mechanical testing to ensure it meets pre-defined physical and mechanical properties and functions as intended, rather than through clinical studies with human readers or ground truth established by experts.

Given that context, here's an attempt to extract the closest relevant information based on the questions, acknowledging the significant mismatch in the type of device and study described:

1. Table of acceptance criteria and the reported device performance

For this physical device, "acceptance criteria" would typically refer to engineering specifications and mechanical performance benchmarks. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Functioned as intended	"The Lanx Spinal Fixation System functioned as intended"
Demonstrate substantial equivalence to predicate device	"the observed test results demonstrate substantial equivalence to the predicate device."
Comparable properties to previously cleared system	"Testing also demonstrated comparable properties to the previously cleared Lanx Spinal Fixation System."
No new issues of safety or effectiveness	"The minor differences in the modified components do not raise any new issues of safety or effectiveness."

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

Test Set Sample Size: Not applicable/not mentioned in the context of clinical data for a diagnostic device. The "test set" here would refer to components undergoing mechanical testing. The specific number of components or test specimens is not provided.
Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to mechanical test results.

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

Number of Experts: Not applicable. Ground truth for a physical device is established through documented engineering standards, mechanical tests, and material science, not human expert consensus on clinical data.
Qualifications of Experts: This would involve mechanical engineers, material scientists, and quality control personnel, but their specific roles or qualifications are not detailed in this summary.

4. Adjudication method for the test set

Adjudication method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert readings for diagnostic accuracy. For mechanical testing, results are typically determined by established test protocols and engineering analysis against acceptance limits.

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

MRMC Study: No. This is a physical spinal fixation system, not a diagnostic AI device.

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

Standalone Performance: Not applicable. There is no algorithm described.

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

Type of Ground Truth: For a physical device, the "ground truth" for performance is defined by engineering specifications, validated mechanical test standards (e.g., fatigue, static strength), and material properties. The document implies compliance with these engineering standards to demonstrate substantial equivalence.

8. The sample size for the training set

Training Set Sample Size: Not applicable. There is no AI/ML model or training set discussed.

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

Ground Truth for Training Set: Not applicable. There is no AI/ML model or training set discussed.

Summary for an AI/ML context:

Based only on the provided text, there is no information about acceptance criteria or a study that typically applies to an AI/ML diagnostic device (e.g., sensitivity, specificity, clinical accuracy, reader studies). The document describes a traditional medical device (spinal fixation system) evaluated primarily through mechanical performance data and substantial equivalence to a predicate device.

Summary

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510(k) SUMMARY Lanx Spinal Fixation System

Submitter Information					MAR - 4 2009
Name and Address:	Lanx, Inc.
	390 Interlocken Crescent, Suite 890
	Broomfield, CO 80021
Contact Person:	Andrew Lamborne
Date Prepared:	January 29, 2009
Device Identification
Proprietary Name:	Lanx Spinal Fixation System
Common Name:	Spinal Fixation System
Classification:	Pedicle Screw Spinal System 21 CFR 888.3070 and/or SpinalInterlaminal Fixation Orthosis 21 CFR 888.3050
Device Class:	Class II

Predicate Device Information

Lanx Spinal Fixation Systcm (K043484, K071633, K071877)

Intended Use / Indications for Use

The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

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Technological Characteristics

Performance Data

Performance testing and engineering analysis was performed and submitted to characterize the modified components of the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.

Substantial Equivalence

The Lanx Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate system. The minor differences in the modified components do not raise any new issues of safety or effectiveness. Testing also demonstrated comparable properties to the previously cleared Lanx Spinal Fixation System. Thus, the modified Lanx Spinal Fixation 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

4 2009 MAR

Re: K090252

Trade/Device Name: Lanx Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI Dated: January 29, 2009 Received: February 2, 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

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 Statement

510(k) Number (if known):

K010252

Device Name:

Indications for Use:

The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

The Lanx SFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device. intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

h. c.m.d. fo mxm

(Division Sign-Oral, Restorative, DAVIsion of Ogical Devices

Page | of

k) Number

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.