The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

The Theken VU MESH VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.

The Theken VU MESH VBR SYSTEM is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

Device Description

The Theken Vu Mesh VBR system is comprised of square footprint polymer cages with fenestrations axially and laterally. It includes toothed endplates, which are used in combination with optional spacer components to extend the range of the cage in smaller increments. The cages, spacers and endplates can be assembled in a variety of combinations to fit each individual patient's pathology. The toothed endplates engage with the superior and inferior endplates of the neighboring vertebral bodies to resist rotation and migration. The Vu Mesh cage may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the mesh cage oriented vertically.

AI/ML Overview

This is a 510(k) summary for a medical device called the "Theken Vu Mesh VBR System," which is a vertebral body replacement device. 510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the requested information regarding acceptance criteria, study details, and human reader performance with AI assistance is not available in this document.

This document primarily outlines:

Device Information: Trade name, common name, classification, materials, and description.
Intended Use: For thoracolumbar spine (T1-L5) to replace unstable vertebral bodies due to tumor or trauma, to restore biomechanical integrity, and for use with supplemental spinal fixation systems.
Predicate and Comparative Devices: A list of previously cleared devices to which the Vu Mesh VBR System claims substantial equivalence.
Substantial Equivalence Argument: The argument is based on similarities in intended use, design, physical characteristics, and material composition to existing devices. Mechanical testing and engineering analysis are mentioned as part of the evidence.

Therefore, I cannot provide the specific details about acceptance criteria and study data as requested because this information is not typically included in a 510(k) summary focused on substantial equivalence.

For completeness, if this were a document that did contain such a study, here's how I would apply your requested framework (displaying what would be absent in this specific document):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Threshold/Target	Reported Device Performance	Meets Criteria?
(Not available in this 510(k) summary)	(Not available)	(Not available)	(Not available)

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: (Not available in this 510(k) summary)
Data Provenance: (Not available in this 510(k) summary. Given the nature of a 510(k) for an implant, any testing would likely be bench testing rather than clinical data from human subjects unless specifically required for novel aspects.)
- If clinical data were involved, it would specify: e.g., "Retrospective, multi-center data from 3 US hospitals" or "Prospective, single-center study in Germany."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: (Not available in this 510(k) summary)
Qualifications of Experts: (Not available in this 510(k) summary)
- If applicable, this would state: e.g., "3 board-certified orthopedic surgeons with >15 years of experience in spinal surgery."

4. Adjudication Method for Test Set

Adjudication Method: (Not available in this 510(k) summary)
- If applicable, this would state: e.g., "2+1 consensus: two readers independently reviewed cases, and a third senior reader resolved disagreements."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, this document does not describe an MRMC study.
Effect size of human readers with AI vs. without AI assistance: Not applicable, as no MRMC study with AI assistance is described.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? No, this document describes a physical medical device (vertebral body replacement system), not an algorithm or AI. Performance is assessed through substantial equivalence to existing devices and mechanical testing.

7. Type of Ground Truth Used

Type of Ground Truth: (Not applicable as this is a physical device and the 510(k) focuses on substantial equivalence based on design and materials, supported by mechanical testing, rather than an AI/diagnostic algorithm using clinical ground truth.)
- If applicable (e.g., for an AI diagnostic device), this would specify: e.g., "Pathology reports (gold standard)" or "Clinical outcomes data (e.g., patient follow-up over 12 months)."

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set Was Established

Method for Establishing Ground Truth: Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

Summary

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Theken Spine

Vu Mesh VBR

2/1/2007

070381

510(K) Summary (21 CFR Part 807.92)

A. Submitter Information

Submitter's Name: Address:

Telephone Number: Fax Number: Contact Person: Date Prepared:

Trade Name:

B. Device Information

Theken Spine 283 E. Waterloo Akron, Ohio 44319 330-773-7677 x221 330-773-7697 Dale Davison 16 January 2007

Theken Vu Mesh Vertebral Body Replacement (VBR)

toothed endplates engage with the superior and inferior endplates of the neighboring vertebral bodies to resist

individually or in a pair depending on the surgical need, however, the device is always implanted with the mesh cage

The Vu Mesh cage may be used

APR 2 5 2007

Common Name: Vertebral Body Replacement Device Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 888.3060) Device Classification: Class II (per 21 CFR 888.3060) Panel: Orthopedic, Product Code: MQP, Panel Code: 87 Predicate Device: Theken Surgical L.LC Reveal VBR System (K050058) Comparative Devices: DePuy-AcroMed, Inc .- Surgical Titanium Mesh System (K003043) Synthes (USA)- SynMesh Spacer System (K003275) Encore Orthopedics, Inc. - Titanium Mesh (K032371) SIGNUS Medical LLC -Curved PEEK Tetris™ (K041888) SIGNUS Medical LLC - PEEK Tetris™ (K031757) Material Composition: PolyEtherEtherKetone (PEEK OPTIMA LT) per ASTM F2026. Tantalum per ASTM F560 Subject Device Description: The Theken Vu Mesh VBR system is comprised of square footprint polymer cages with fenestrations axially and laterally. It includes toothed endplates, which are used in combination with optional spacer components to extend the range of the cage in smaller increments. The cages, spacers and endplates can be assembled in a variety combinations to fit each individual patient's pathology. The

rotation and migration.

oriented vertically,

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K070381/
Page 2 of 2

Theken Spine

Intended Use:

Vu Mesh VBR

2/1/2007

The Theken VU MESH VBR System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

The Theken VU MESH VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing into the interior opening of the device prior to implantation.

The Theken VU MESH VBR System is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

Substantial Equivalence ে

The technological characteristics of the Theken Vu Mesh VBR SYSTEM are similar to the following predicate devices:

REVEAL VBR System (K050058) manufactured by Theken Spine LLC and 1. cleared by the FDA on May 17, 2005.
1. Surgical Titanium Mesh System (K003043) manufactured by DePuy-AcroMed, Inc. and cleared by the FDA on May 8, 2001.
1. SynMesh Spacer System (K003275) manufactured by Synthes (USA) and cleared by the FDA on April 23, 2001.
1. Titanium Mesh (K032371) manufactured by Encore Orthopedics, Inc and cleared by the FDA on February 12, 2004
Curved PEEK Tetris™ (K041888) manufactured by SIGNUS Medical LLC and ട്. cleared by the FDA on August 10, 2004.
PEEK Tetris™ (K031757), manufactured by SIGNUS Medical LLC and cleared 6. by the FDA on July 3, 2003.

Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and have equivalent potential for complications. Based on the design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis, Theken Spine believes that sufficient evidence exists to reasonably conclude that the Vu Mesh VBR System is substantially equivalent to existing legally marketed devices.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Theken Spine c/o Mr. Dale Davison Vice President of Engineering 283 East Waterloo Road Akron, Ohio 44319

APR 2 5 2007

Re: K070381

Trade/Device Name: Vu Mesh VBR System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: March 30, 2007 Received: April 02, 2007

Dear Mr. Davison:

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.

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Page 2 - Ms. Dale Davison

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.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchup

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

Enclosure

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Theken Spine

Vu Mesh VBR

2/1/2007

Indications for Use

510(k) Number (if known):

Device Name: Vu MESH VBR System

Indications For Use:

The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

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

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __ 1

Barbave Buchm

Division Sion Division of General, Restorative. and Neurological Devices

510(k) Number_Ko 70381

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.