VU E*POD VERTEBRAL BODY REPLACEMENT by THEKEN SPINE LLC

The Vu e.POD Vertebral Body Replacement 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 (ie. fracture).

The Vu e.POD Vertebral Body Replacement 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 Vu e.POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical. LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).

Device Description

The Vu e•POD Vertebral Body Replacement is comprised of PEEK concave cages with fenestrations and radii on all sides and toothed spikes used in combination with a titanium spacer component. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu e•POD Vertebral Body Replacement may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the construct oriented vertically.

AI/ML Overview

The provided documentation describes a 510(k) submission for the "Vu e•POD Vertebral Body Replacement" device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and detailed reporting of reader performance. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader performance (human or AI) is not typically part of a 510(k) summary for a spinal implant.

Instead, the submission focuses on demonstrating that the new device has the same indications for use, basic design, operating principle, materials, surgical techniques, supplemental fixation requirements, manufacturing environment, sterilization process, and packaging configurations as the predicate devices. The "study" mentioned is primarily a series of mechanical tests and design comparisons rather than a clinical trial.

Here's a breakdown based on the provided text, addressing your points where possible and noting where the information is not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, not necessarily quantitative performance metrics against a predefined clinical or diagnostic standard in the way an AI/diagnostic device might have. The "device performance" is therefore implicitly that it functions equivalently to the predicate devices.

Acceptance Criteria (Demonstrated)	Reported Device Performance (Demonstrated)
Same indications for use	Verified against predicate device's IFU
Same basic design	Visual and compositional comparison
Same operating principle	Functional comparison
Same materials	Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026, Tantalum per ASTM F-560, Titanium 6Al-4V ELI per ASTM F-136, same as predicate
Implanted using same surgical techniques and equipment type	Confirmed by manufacturer
Used in conjunction with same supplemental fixation	Confirmed with specified systems
Same manufacturing environment	Confirmed by manufacturer
Same sterilization process	Confirmed by manufacturer
Same packaging configurations	Confirmed by manufacturer
Mechanical Testing Results	Not explicitly detailed, but stated as performed for equivalence demonstration

Note: The above table reflects the criteria for demonstrating substantial equivalence, which is the core "acceptance criterion" for a 510(k) device. Specific quantitative performance metrics like sensitivity, specificity, or reader improvement in an MRMC study are not applicable to this submission type.

Study Details (as inferable from a 510(k) for a spinal implant):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of a clinical trial. The "test set" here would refer to the physical devices subjected to mechanical testing. The number of devices tested is not specified but would typically follow ISO/ASTM standards for medical device testing.
- Data Provenance: Not applicable. The "data" primarily consists of mechanical test results and material characterization, not patient data.
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. "Ground truth" in the clinical/diagnostic sense is not established for this type of device. The ground truth for mechanical testing would be established by validated test methods and engineering principles. Expertise would come from engineers/scientists performing the tests, not medical professionals interpreting diagnostic data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies among expert readers in diagnostic studies. For mechanical testing, resolution of discrepancies would follow standard engineering practices or test method protocols.
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:
- No, an MRMC study was not done, and it is not relevant for this type of device (a vertebral body replacement implant). This is a surgical implant, not a diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical/diagnostic sense. For the mechanical testing performed, the "ground truth" is based on established engineering principles, material specifications (ASTM standards for PEEK, Tantalum, Titanium), and validated test protocols designed to assess mechanical properties like strength, fatigue, and stability.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an algorithm or AI for this device.
How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.

In summary: The provided document is a 510(k) summary for a medical implant, the Vu e•POD Vertebral Body Replacement. Its regulatory pathway relies on demonstrating "substantial equivalence" to existing cleared predicate devices, primarily through comparison of design, materials, indications for use, and mechanical testing, rather than extensive clinical trials or performance assessments against specific diagnostic criteria. Therefore, most of the questions pertaining to AI/diagnostic study design (like sample size, number of experts, ground truth, MRMC studies) are not applicable to this submission.

Summary

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Vu e•POD Vertebral Body Replacement

K07/031

4/9/2007

	510(k) Summary(21 CFR Part 807.92)
A. Submitter Information
Submitter's Name:Address:	Theken Spine, LLC283 E. WaterlooAkron, Ohio 44319
Telephone Number:Fax Number:Contact Person:Date Prepared:	330-773-7677 x221330-773-7697Dale Davison4/9/07JUL 30 2007
B. Device Information
Trade Name:	Vu e•POD Vertebral Body Replacement (VBR) System
Common Name:	Vertebral Body Replacement Device
Classification Name:	Spinal Intervertebral Body Fixation Orthosis (per 21 CFR888.3060)
Device Classification:	Class II (per 21 CFR 888.3060)Panel: Orthopedic, Product Code: MQP, Panel Code: 87
Predicate Device:	Theken Surgical, LLC CPOD/LPOD VBR System (K032064)Theken Surgical, LLC REVEAL VBR System (K050058)
Material Composition:	Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026Tantalum per ASTM F-560Titanium 6Al-4V ELI per ASTM F-136
Subject Device Description:	The Vu e•POD Vertebral Body Replacement is comprised ofPEEK concave cages with fenestrations and radii on all sides andtoothed spikes used in combination with a titanium spacercomponent. The cages and spacer can be locked together into avariety of geometric configurations to fit each individual patient'spathology. The toothed spikes of the concave cages engage withthe superior and inferior end plates of the neighboring vertebralbodies to resist rotation and migration. The Vu e•POD VertebralBody Replacement may be used individually or in a pair dependingon the surgical need, however, the device is always implanted withthe construct oriented vertically.
Intended Use:	The Vu e•POD Vertebral Body Replacement is indicated for use inthe thoracolumbar spine (T1-L5) to replace a collapsed, damaged,or unstable vertebral body due to tumor or trauma (e.g., fracture).
	The Vu e•POD Vertebral Body Replacement is designed to restorethe biomechanical integrity of the anterior, middle, and posteriorspinal column even in the absence of fusion for a prolonged period.Bone graft material is recommended to be packed into the interioropenings of the device prior to implantation.
	The Theken Vu e•POD Vertebral Body Replacement is intended tobe used with supplemental internal spinal fixation systems, such asthe Theken Surgical, LLC, BodyForm Thoracolumbar Fixation

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System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).

C. Substantial Equivalence

The technological characteristics of the Vu e•POD Vertebral Body Replacement are similar to the predicate device CPOD / LPOD Vertebral Body Replacement System (K032064), manufactured by Theken Surgical, LLC and cleared by the FDA on February 20, 2004 and REVEAL Vertebral Body Replacement, (K050058), Manufactured by Theken Surgical, LLC and clear by the FDA on May 17, 2005

The subject device similarities include:

. The same indications for use
. The same basic design
. The same operating principle
. The same materials
Implanted using the same surgical techniques and equipment type ●
. Used in conjunction with the same supplemental fixation
The same manufacturing environment .
. The same sterilization process
The same packaging configurations .

Theken Spine believes that sufficient evidence exists to reasonably conclude that the Vu e.POD Vertebral Body Replacement is substantially equivalent to the predicate device REVEAL Vertebral Body Replacement (K050058), manufactured by Theken Surgical, LLC and cleared by the FDA on May 17, 2005. This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis. All implants are used to treat the same conditions, have the same precautions and contraindications for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Theken Spine, LLC % Mr. Dale Davison 283 East Waterloo Road Akron, Ohio 44319

JUL 3 0 2007

Re: K071031

Trade/Device Name: Vu e•POD Vetebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 10, 2007 Received: April 11, 2007

Dear Mr. Dale 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.

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. Dale Davison

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

Sincerely yours,

Kabara Buchup

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

510(k) Number (if known): KO7103)

Device Name: Vu e.POD Vetebral Body Replacement

Indications For Use:

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

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)

Harbare Buchw

Division of General, Restorative, and Neurological Devices

510(k) Number K07103

Page 1 of 1

D-2

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.