The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.

Device Description

The V2F™ Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumbar plates, cap screws, bone screws and instrumentation necessary for implantation of the system.

The V2FTM Anterior Fixation System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anteriorlateral approach. All implant components are manufactured from titanium alloy as specified in ASTM F136.

AI/ML Overview

Here's an analysis of the provided text regarding the V2F™ Anterior Fixation System, focusing on acceptance criteria and supporting studies:

This submission is for a medical device (spinal fixation system), and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally related to mechanical performance and substantial equivalence to predicate devices, rather than diagnostic performance or algorithm efficacy which would involve the concepts of sensitivity, specificity, human readers, ground truth consensus, etc.

Therefore, many of the questions related to AI/algorithm performance (e.g., sample size for test set, experts, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Static Compression Bending (ASTM F1717)	"The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s)."	The specific numerical acceptance criteria (e.g., minimum load, displacement) are not provided in this summary. The performance is stated in terms of meeting the intent and being substantially equivalent to the predicates.
Static Torsion (ASTM F1717)	"The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s)."	Similar to static compression bending, detailed numerical results are not included, but the general conclusion of substantial equivalence is given.
Dynamic Compression Bending (ASTM F1717)	"The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s)."	Similar to the static tests, the device's performance in dynamic compression bending is reported as meeting the intended function and achieving substantial equivalence.

Study Proving Acceptance Criteria:

The study referenced is based on mechanical testing according to ASTM F1717 standards. The specific tests performed were:

Static compression bending
Static torsion
Dynamic compression bending

The conclusion drawn from these tests is that the V2F™ Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s). The predicate devices used for comparison are:

InCompass Spinal Fixation System (K021564)
Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K020244)

Additional Information (Where Applicable)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable (N/A): This is a mechanical device. The "test set" would refer to the number of physical samples of the device components subjected to the ASTM F1717 tests. This information (specific number of samples tested) is not detailed in the summary but would be part of the full test report. Data provenance (country, retrospective/prospective) is not relevant for mechanical testing of this nature.
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):
- N/A: Ground truth in the context of diagnostic or AI performance is not relevant for the mechanical testing of a spinal fixation system. The "ground truth" for mechanical testing is defined by the ASTM standards themselves and the physical laws governing material properties and structural integrity.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Adjudication methods are used to resolve discrepancies in human interpretations or classifications, typically in the context of diagnostic performance studies. This is not applicable to standardized mechanical engineering tests.
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:
- N/A: MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a surgical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This submission is for a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: As mentioned, ground truth in this context refers to the adherence to established mechanical testing standards (ASTM F1717) and the physical properties of the materials and design compared to predicates.
The sample size for the training set:
- N/A: There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- N/A: No training set exists.

Summary of Device Performance Determination:

The V2F™ Anterior Fixation System's acceptance criteria are centered on its mechanical properties and performance. The device is deemed to meet these criteria by demonstrating substantial equivalence to predicate devices through conformity to the ASTM F1717 standard for static compression bending, static torsion, and dynamic compression bending. The "study" is the mechanical testing conducted according to this recognized standard.

Summary

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K122733 Page 1 of 2

DEC 07 2012

510(k) Summary

Submitter:

Author:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate(s):

Zimmer Spine 5301 Riata Park Court, Bldg F Austin, TX 78727

Jennifer Tribbett Senior Regulatory Affairs Specialist

Jennifer Tribbett Senior Regulatory Affairs Specialist Telephone: (512) 533-1061 Fax: (512) 219-5463

September 5, 2012

V2FTM Anterior Fixation System

Spinal Fixation System

Orthosis, Spinal Intervertebral Fixation 21 CFR § 888.3060, KWQ, Class II

· InCompass Spinal Fixation System (K021564)

· Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K020244)

Device Description:

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Indications for Use:

The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.

Performance Data:

ASTM F1717 static compression bending, static torsion and dynamic compression bending were performed to establish substantial equivalence. The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s).

Basis of Substantial Equivalence:

The V2F™ Anterior Fixation System is similar to the predicate devices with respect to technical characteristics, design, materials, performance and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: December 7, 2012

Zimmer Spine % Mr. Ron Yarbrough Director of Regulatory Affairs 5301 Riata Park Court, Building F Austin. Texas 78727

Re: K122733

Trade/Device Name: V2F™ Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: October 18, 2012 Received: October 24, 2012

Dear Mr. Yarbrough:

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. 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

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Page 2 - Mr. Ron Yarbrough

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/CDRH/CDRHOffices/ucm115809.htm 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 vours.

Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopaedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: V2FTM Anterior Fixation System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Caroline Rhim -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122733

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.