The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Device Description

The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.

The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.

The device is supplied in an appropriately labeled sterile packaging.

The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

AI/ML Overview

The provided text describes the Wenzel Spine VariLift Cervical Interbody Fusion System, which is a medical device. It does not describe a device that uses AI or machine learning, nor does it present any studies involving acceptance criteria or comparative effectiveness in the way an AI/ML device submission would.

Therefore, for each of your requested points, the answer is that the information is not applicable or not provided in the given summary because the device is a physical interbody fusion system, not an AI/ML diagnostic or assistive tool.

Here's a breakdown based on your request, directly addressing why the information isn't present:

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

Not Applicable / Not Provided: The document focuses on demonstrating substantial equivalence to predicate devices through design, material, and non-clinical mechanical testing. It does not define acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) that would be relevant for an AI/ML device. The "performance" is demonstrated by meeting mechanical testing standards (ASTM F2077-03) and claiming substantial equivalence to existing devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: This question is relevant for AI/ML validation datasets. For a physical medical device like the VariLift, "test set" would refer to the samples used in mechanical testing. The document states "Static and dynamic compression testing," "Static shear testing," "Static and dynamic torsion testing," and "Expulsion testing" were conducted in accordance with ASTM standards, but it does not specify the sample sizes (number of devices tested) for these non-clinical tests or any "data provenance" as that term is used in AI/ML.

3. 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 / Not Provided: "Ground truth" established by experts is a concept for AI/ML performance evaluation where human judgment is the reference. For this physical device, the "ground truth" for mechanical testing is defined by the ASTM standards (e.g., maximum load before failure, displacement at a certain load). No human experts are used to establish "ground truth" in this context.

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

Not Applicable / Not Provided: Adjudication methods like 2+1 or 3+1 are used in AI/ML studies when multiple human readers independently review cases and then resolve disagreements to establish a consensus ground truth. This is not relevant for the mechanical testing of a physical implant.

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

Not Applicable / Not Provided: An MRMC study is designed to evaluate the impact of an AI tool on human reader performance. Since the VariLift is a physical interbody fusion system and not an AI-powered tool, such a study would not be performed for this device.

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

Not Applicable / Not Provided: This question pertains to the performance of an AI algorithm on its own. The VariLift is a physical device, so there is no "algorithm only" performance to evaluate.

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

Not Applicable / Not Provided: As in point 3, the concept of "ground truth" as a reference for diagnostic accuracy is not directly applicable. For non-clinical mechanical testing, the "truth" is whether the device meets predefined physical performance specifications according to standardized test methods (like ASTM F2077-03).

8. The sample size for the training set

Not Applicable / Not Provided: A "training set" is used to develop or train an AI/ML model. This device is a physical implant, not an AI/ML model, so there is no training set involved.

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

Not Applicable / Not Provided: Since there is no training set for an AI/ML model, the establishment of ground truth for such a set is irrelevant for this medical device submission.

Summary

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, 111123

Wenzel Spine VariLift Cervical Interbody Fusion System

510(k) Summary of Safety and Effectiveness

SUBMITTED BY	Wenzel Spine
	206 Wild Basin Rd
	Building A, Suite 203
	Austin, TX 78746

ESTABLISHMENT	3008009850
REGISTRATION NUMBER

CONTACT PERSON Sourabh Mishra Chief Technology Officer Phone: 512-501-4017 Fax: 512-469-0604

SUBMISSION PREPARED BY J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 ortho.medix@sbcglobal.net Phone: 512-388-0199 Fax: 512-692-3699
April 12, 2011 DATE PREPARED

CLASSIFICATION NAME ODP 888.3080 - Intervertebral Fusion Device with Bone Graft, Cervical

Intervertebral Body Fusion Device COMMON NAME

VariLift Interbody Fusion System (VariLift-C) PROPRIETARY NAME

IDENTIFICATION OF PREDICATES

BAK®/C Vista Cage (P980048 S003) BAK®/Cervical Interbody Fusion (P980048) LDR Interbody Fusion System (K091088)

DEVICE DESCRIPTION

The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.

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KIIII 23

The device is supplied in an appropriately labeled sterile packaging.

The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The VariLift Cervical Interbody Fusion System is substantially equivalent to the BAK®/C Vista Cage in terms of intended use, design, and materials used. The table below compares the features and characteristics of the VariLift Cervical Interbody Fusion System to these predicate devices.

Items	VariLift Cervical Interbody Fusion System	BAK®/C Vista Interbody Fusion System
Sponsor	Wenzel Spine	Zimmer
510(K) Number	N/A	P980048 S003
Indications for Use	Per FDA Guidance	Per FDA Guidance
Material	Ti-6Al-4V alloy per ASTM F136	PEEK Optima LT1
Implant Levels	One Level	Once Level
# Implants per level	Single or Pairs	Single or Pairs
Supplemental Fixation	With Supplemental Fixation	With or Without Supplemental Fixation

INDICATIONS:

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with l ASTM F2077-03
Static shear testing, conducted in accordance with ASTM F2077-03 "
Static and dynamic torsion testing, conducted in accordance with ASTM -F2077-03
Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02

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KIII23

CONCLUSIONS

The subject and predicate devices share the same intended use, implant design and material of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The nonclinical and clinical test results demonstrate that the VariLift Cervical Interbody Fusion System is substantially equivalent to the predicate devices and support the use of VariLift-C with supplemental fixation.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is black and appears to be part of a larger document or logo. To the left of the text is a graphic of three diagonal lines.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC - 8 2011

Wenzel Spine % The OrthoMedix Group, Inc. Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K111123

Trade/Device Name: Wenzel Spine VariLift Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 9, 2011 Received: November 14, 2011

Dear Mr. Webb:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Mr. J. D. Webb

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Fer. Piffner
Dec. 66.

Mark N. Melkerso Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 111 123

INDICATIONS FOR USE

510(k) Number (if known):

Wenzel Spine VariLift Cervical Interbody Fusion System Device Name:

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIIII23 510(k) Number_

2720 Bee Cave Road Austin, Texas 78746 Wenzel Spine

Phone: 512-501-40 Fax: 512-469-0604

.1061

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.