When used as an intervertebral body fusion device, the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR) the Vu ePOD and Vu LPOD 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 (ie. fracture).

The Vu ePOD and Vu LPOD 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. The device is indicated for use with autograft or allograft only.

The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.

Device Description

The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are comprised of PEEK OPTIMA-LT cages with fenestrations and radii on all sides and toothed ridges. The toothed ridges of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu ePOD is a straight shaped cage while the Vu LPOD has a curved shape. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices may be used individually or in a pair depending on the surgical need.

AI/ML Overview

The provided document is a 510(k) Summary for the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering and mechanical testing, rather than extensive clinical studies on human subjects.

Therefore, many of the typical acceptance criteria and study design elements found in a clinical study for a medical image analysis AI device (like human reader performance, expert consensus on ground truth for AI training/testing, MRMC studies, etc.) are not applicable to this submission.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Tests/Standards	Reported Device Performance
Mechanical Integrity	Static Axial Compression (ASTM F-2077, ASTM F-2267)	Performed as designed and met or exceeded all product specifications.
	Static Compression Shear (ASTM F-2077, ASTM F-2267)	Performed as designed and met or exceeded all product specifications.
	Dynamic Axial Compression (ASTM F-2077, ASTM F-2267)	Performed as designed and met or exceeded all product specifications.
	Dynamic Compression Shear (ASTM F-2077, ASTM F-2267)	Performed as designed and met or exceeded all product specifications.
	Subsidence (ASTM F-2077, ASTM F-2267)	Performed as designed and met or exceeded all product specifications.
	Expulsion (ASTM F-2077, ASTM F-2267)	Performed as designed and met or exceeded all product specifications.
Substantial Equivalence	Similar indications for use to predicate device	Yes, similar to Vu aPOD and predicate REVEAL VBR.
	Similar basic design	Yes, similar to Vu ePOD and Vu LPOD.
	Similar operating principle, materials, manufacturing, sterilization, packaging	Yes.
	Used with supplemental fixation	Yes.

2. 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 explicitly stated as a number of devices. The "Summary of Test Data" indicates that "Mechanical testing of the subject device consisted of static axial compression, static compression shear, dynamic axial compression, dynamic compression shear, subsidence and expulsion." This implies that a sufficient number of device samples were manufactured and tested according to the specified ASTM standards.
Data Provenance: The device manufacturer is Theken Spine, LLC, located in Akron, Ohio, USA. The testing was conducted in accordance with ASTM (American Society for Testing and Materials) standards. The data is from prospective mechanical testing conducted on manufactured devices, not from human subjects or retrospective clinical data.

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

This is not applicable. The ground truth for this device's performance is established through objective mechanical engineering tests against defined performance specifications and ASTM standards, not through expert human assessment of images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Mechanical test results are quantitative and objective. There is no need for human adjudication of the test results themselves, only for the interpretation and comparison against pre-defined engineering specifications.

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

This is not applicable. This is a device for intervertebral body fusion and vertebral body replacement, not an AI device or a diagnostic imaging tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

This is not applicable. There is no algorithm or AI component in this medical device.

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

The "ground truth" for this device's performance is the pre-defined engineering specifications derived from relevant ASTM standards (ASTM F-2077, ASTM F-2267) and the device's design requirements. The mechanical tests verify that the device meets these objective, quantifiable standards for strength, stability, and durability.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/algorithm for this device. The development of the device's design and manufacturing processes is informed by engineering principles and materials science, not machine learning training data.

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

This is not applicable. As there is no training set for an AI/algorithm, there is no ground truth established in this context. The design and performance requirements (analogous to "ground truth" for traditional medical devices) are based on biomechanical principles, clinical needs, and regulatory standards.

Summary

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510(k) Summary (21 CFR Part 807.92)

Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices

MAX 888.3080 (Class II) - Intervertebral body fusion device

Theken Surgical REVEAL VBR System, K050058

Theken Spine Vu ePOD System, K071031 Theken Spine Vu aPOD System, K080822

MQP 888.3060 (Class II) - Spinal intervertebral body fixation orthosis

Intervertebral body fusion device

A. Submitter Information

Submitter's Name:	Theken Spine, LLC
Establishment Registration #:	1530901
Address:	1800 Triplett Blvd. Akron, Ohio 44306
Telephone Number:	330-475-8600
Fax Number:	330-773-7697
Contact Person:	Dale Davison
Date Prepared:	9/12/2008

JAN - 2 2009

B. Device Information

Trade Name:

Common Name:

Classification:

Predicate Devices:

Device Description:

Summary of Test Data:

Intended Use:

Mechanical testing of the subject device consisted of static axial compression, static compression shear, dynamic axial compression, dynamic compression shear, subsidence and expulsion. Testing was conducted in accordance with ASTM F-2077 and ASTM F-2267. The construct performed as designed and met or exceeded all product specifications.

When used as an intervertebral body fusion device the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

Page 1 of 2

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The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.

C. Substantial Equivalence

The technological characteristics of the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are similar to the predicate device REVEAL Vertebral Body Replacement (K050058), the Theken Spine Vu ePOD System (K071031) and the Theken Spine Vu aPOD System (K080822).

The subject device similarities include:

The same indications for use as the Vu aPOD �
The same basic design as the Vu ePOD and Vu LPOD .
The same operating principle
The same materials
Used in conjunction with 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 ePOD and Vu LPOD Intervertebral Body Fusion Devices are substantially equivalent to the predicate device REVEAL Vertebral Body Replacement (K050058), the Theken Spine Vu ePOD System (K071031) and the Theken Spine Vu aPOD System (K080822). 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 represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.

Page 2 of 2

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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 features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using a black and white color scheme.

Public Health Service

Food and Drug. Administration 9200 Corporate Boulevard Rockville MD. 20850

Theken Spine, LLC % Mr. Dale Davison 1800 Triplett Blvd Akron, OH 44306

JAN - 2 2009

Re: K082712

Trade/Device Name: Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX, MQP Dated: December 30, 2008 Received: December 31, 2008

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.

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 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 the reporting 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/cdrl/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

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): K082712

Device Name: Theken Spine Vu ePOD and Vu LPOD System

Indications for Use:

The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

MARYANN H. LLOYD FOR M.MELKERSON

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

510(k) Number K082712

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.