The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to LS) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Device Description

Implants: The Lanx VBR implants consists of a series of flat, trapezoidal, rectangular and curved shaped The device is offered in different size/configurations to better approximate the anatomical implants. variation observed in different vertebral levels and/or patient anatomy. The devices are manufactured with a hollowed out central area to accommodate bone graft material. The upper and lower surfaces are manufactured in such a way that a series of transverse slots or grooves are formed to improve stability and fixation once the device is inserted.

Materials: all implants are made from implant grade PEEK with titanium position markers, Instruments: The instruments are made from instrument grade stainlens steel.

AI/ML Overview

The provided 510(k) summary describes a spinal intervertebral body fixation orthosis (Lanx VBR) and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/Software as a Medical Device (SaMD) submission.

This document is a 510(k) Premarket Notification for a physical medical device (a spinal implant made of PEEK with titanium markers), not a software device or AI algorithm. Therefore, the questions related to AI/MRMC studies, ground truth, training sets, and sample sizes for test sets in the context of AI/SaMD are not applicable to the information provided.

The "Testing Summary" section is the only part that mentions device performance.

Here's an analysis based on the provided text, highlighting the absence of information relevant to AI/SaMD acceptance criteria and studies:

Acceptance Criteria and Device Performance (as described for this physical device)

Acceptance Criteria	Reported Device Performance
Fatigue Testing	"Fatigue and static testing is complete." "Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device."
Static Testing	"Fatigue and static testing is complete." "Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device."
Biocompatibility	"Additionally, a device material Master File (MAF) recorded with the FDA provided additional biocompatibility information."
Material Composition	Not explicitly stated as a pass/fail criterion, but the device is made from implant grade PEEK with titanium position markers. Equivalence to predicates is mentioned based on material composition.
Surgical Technique	Not explicitly stated as a pass/fail criterion, but equivalence to predicates is mentioned based on surgical technique.
Intended Use	Not explicitly stated as a pass/fail criterion, but equivalence to predicates is mentioned based on intended use.

Regarding the specific questions which are geared towards AI/SaMD:

A table of acceptance criteria and the reported device performance: See table above. It describes general testing results for a physical device, not typically quantitative metrics for AI.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This information is for AI/SaMD. The document refers to "samples" for fatigue and static testing, which would be physical implant units, not data sets. No specific sample size for these physical tests is provided, nor is data provenance relevant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This information is for AI/SaMD. Ground truth in this context would typically refer to clinical diagnoses or annotations for an AI algorithm. For a physical implant, "ground truth" might refer to engineering standards or clinical outcomes observed during physical testing, but no specific expert involvement for this is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This information is for AI/SaMD.
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 is a physical implant, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implant, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical device, the "ground truth" for the fatigue and static testing would be accepted engineering and scientific principles and comparison to predicate device performance. For biocompatibility, it would be data from a device material Master File (MAF) recorded with the FDA. No clinical ground truth (expert consensus, pathology, outcomes data) as understood in an AI/SaMD context is mentioned.
The sample size for the training set:
- Not applicable. This is for AI/SaMD.
How the ground truth for the training set was established:
- Not applicable. This is for AI/SaMD.

Conclusion:

The provided 510(k) summary is for a traditional, physical medical device (spinal implant). It establishes substantial equivalence based on design, material composition, surgical technique, intended use, and fatigue/static testing outcomes that are equivalent to comparison devices. It also references a Material Master File for biocompatibility.

The document does not contain any information pertaining to the development or validation of an Artificial Intelligence (AI) or Software as a Medical Device (SaMD) product. Therefore, the specific questions regarding AI/SaMD acceptance criteria, test/training sets, ground truth establishment, expert adjudication, or MRMC studies cannot be answered from this text.

Summary

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510(k) Summary InformationPremarket Notification, Section 510(k)	Lanx LLCSEPT 17, 2005
----------------------------------------------------------------------	---------------------------

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

1. Device Name:

Trade Name:	Lanx VBR
Common:
Name(s):	Vertebral body replacement
Classification:
Name(s):	Spinal intervertebral body fixation orthosis

2. Establishment Name & Registration Number:

Name:	Lanx LLC
Number:	3004485144

3. Classification(s):

Sec. 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 vetebral 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 fareaded or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "smay back," scoliosis (lateral curvature of the spine), or other conditions,

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

Equivalent Predicate Device:

Lanx LLC believes that the Lanx VBR is substantially equivalent to the following:

K003709, Mesh Cage, Surgical Dynamics
K001340, Stackable Cage, DePuy
K040928, PEEK Cage, Interpore/Cross
K042268, EBI CAS Spine Spacer System, EBI. L.P.

Equivalence can be seen in the design, material composition, surgical technique and intended use.

5. Device Description:

Implants: The Lanx VBR implants consists of a series of flat, trapezoidal, rectangular and curved shaped The device is offered in different size/configurations to better approximate the anatomical implants. variation observed in different vertebral levels and/or patient anatomy. The devices are manufactured with a hollowed out central area to accommodate bone graft material The upper and lower surfaces are manufactured in such a way that a series of transverse slots or grooves are formed to improve stability and fixation once the device is inserted.

Materials: all implants are made from implant grade PEEK with titanium position markers, Instruments: The instruments are made from instrument grade stainlent post

Indications for Use. The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spire (from TI to LS) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of diseased

{1}------------------------------------------------

vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For fixstion is secured to may be most be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Testing Summary. Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device material Master File (MAF) recorded with the FDA provided additional biocompatibility information.

6. Applicant Name & Address:

Lanx, LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: 303-443-7501

7. Company Contact:

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

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax david(@fda-help.com

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized of tills device do not exist Standard Operating Process certification and qualification 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, 516, 516, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act,

I O. Sterilization Information:

The Lanx Spinal Fixation System is supplied "NON-STERILE" and must be sterilized prior to use. The recommended sterlization process is high temperature sterilization. The referenced sterilization cycle produces a Sterility Assurance Level (SAL) of att least 106

The validated cycle is: Method: Steam Cycle: Gravity Temperature: 270°F (134°C) Exposure Time: 18 minutes

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510(k) Summary Information	Lanx LLC
Premarket Notification, Section 510(k)	SEPT 17, 2005

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

1. Device Name:

Lanx VBR Trade Name: Common Name(s): Vertebral body replacement Classification Spinal intervertebral body fixation orthosis Name(s):

2. Establishment Name & Registration Number:

Name:	Lanx LLC
Number:	3004485144

3. Classification(s):

Sec. 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 odiaes. 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 rimed 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.

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

4. Equivalent Predicate Device:

Lanx LLC believes that the Lanx VBR is substantially equivalent to the following:

1. K003709, Mesh Cage, Surgical Dynamics
1. K001340, Stackable Cage, DePuy
1. K040928, PEEK Cage, Interpore/Cross
1. K042268, EBI CAS Spine Spacer System, EBI. L.P.

Equivalence can be seen in the design, material composition, surgical technique and intended use

5. Device Description:

Implants: The Lance VBR implants consists of a series of flat, trapezoidal, rectangular and curved shaped The device is offered in different size/configurations to better approximate the anatomical implants. variation observed in different vertebral levels and/or patient anatomy. The devices are manufactured with a hollowed out central area to accommodate bone graft material. The upper and lower surfaces are manufactured in such a way that a series of transverse slots or grooves are formed to improve stability and fixation once the device is inserted.

Materials: all implants are made from implant grade PEEK with titanium position markers, Instruments: The instruments are made from instrument grade stainlens steel.

Indications for Use. The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body themely when with the thoracolumbar spine (from TI to LS) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of diseased

{3}------------------------------------------------

vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Land VRR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental fixation. Supplemental internal fixation is required to properly utilize this system.

Testing Summary. Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device. Additionally, a device material Master Five (MAF) recorded with the FDA provided additional biocompatibility information.

6. Applicant Name & Address:

Lanx、LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: 303-443-7501

7. Company Contact:

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

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax david@fda-help.com

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized overaliands of tilliged include ASTM, Surtame Rocedures, vendor & process certification and qualification procedures, Qualification procedures, Qualification procedures, Qualification procedures, Qualification pr Systems Regulations, ISO materials standards and ISO 9000 series quality regulations. LANX, LLC, also meets appropriate general controls authorized under Sections 501, 516, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

1 0. Sterilization Information:

The Lanx Spinal Fixation System is supplied "NON-STERILE" and must be sterilized prior to use. The recommended sterilization process is high temperature sterilization of sterilization. The referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 106

The validated cycle is: Method: Steam Cycle: Gravitv Temperature: 270°F (134°C) Exposure Time: 18 minutes

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff entwined with three snakes, representing healing and medicine. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2005

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

Re: K052384

Trade/Device Name: Lanx VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 26, 2005 Received: August 30, 2005

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 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- 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Signature: Mark McMullen

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

Enclosure

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Page 1 of 1

510(k) Number: K052384

LanxVBR Device Name(s):

Indications for Use:

Over-The-Counter Use Prescription Use X OR PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052384

(Per 21 CFR 801.109)

(Optional format 1-2-96)

ાં ર

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.