The Choice Spine Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VBR device is intended for use with supplemental fixation & is to be used with autograft and/or allograft bone graft material.

Device Description

The Choice Spine Vertebral Body Replacement (VBR) System devices have a basic oval shape with a hollow center for placement of bone graft. The superior & inferior surfaces have ridges, or 'teeth' for resisting migration. The devices are available in an assortment of heights & multiple angles of lordosis to accommodate different anatomic requirements.

AI/ML Overview

This 510(k) summary describes a medical device called the "Choice Spine Vertebral Body Replacement (VBR) System," not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML performance studies are not applicable.

However, I can extract information related to the device's mechanical acceptance criteria and the study types performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Type)	Reported Performance (Result)
Mechanical Performance	Demonstrated substantial equivalence to predicate devices through mechanical testing. Specific numerical thresholds are not provided in the summary.
Static Compression	Testing performed according to ASTM F2267-04 and ASTM F2077-03.
Dynamic Compression	Testing performed according to ASTM F2077-03.
Static Torsion	Testing performed according to ASTM F2077-03.
Dynamic Torsion	Testing performed according to ASTM F2077-03.
Subsidence	Testing performed according to ASTM F2267-04.
Expulsion	Testing performed.
Material Biocompatibility	Manufactured from PEEK OPTIMA® (ASTM F2026) and Tantalum (ASTM F560), similar to predicate devices.
Functional Equivalence	Intended use, indications, and anatomic location are identical or similar to predicate systems.

2. Sample size used for the test set and the data provenance

Sample Size: This is a mechanical device, not an algorithm. The "sample size" refers to the number of devices or test specimens subjected to mechanical testing. The exact number of test specimens is not specified in the 510(k) summary but would be reported in the full test reports referenced by the ASTM standards.
Data Provenance: The mechanical testing was performed in the context of demonstrating substantial equivalence for a medical device (spinal implant). The data provenance is from laboratory mechanical testing, not clinical data or human subjects.

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

Not applicable. This is a mechanical device, and "ground truth" in the context of expert consensus or clinical outcomes is not relevant here. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F2267-04, ASTM F2077-03) and the quantitative measurements against those standards.

4. Adjudication method for the test set

Not applicable. This is a mechanical device.

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. This is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance relies on validated engineering standards and quantitative measurements of mechanical properties (e.g., load-bearing capacity, resistance to subsidence, resistance to expulsion, fatigue life). The acceptance criteria are typically defined as meeting or exceeding the performance of legally marketed predicate devices, as assessed by these standardized tests.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a mechanical device, not an AI algorithm.

Summary

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510(k) Summary

Preparation Date

22 February 2012

Sponsor

Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 p: 865.246.3333 f: 865.588.4045

Contact

Mark Bekkala

Trade Name

Choice Spine Vertebral Body Replacement (VBR) System

Common Name

Spinal Vertebral Body Replacement Device

Regulatory Classification & Device Product Codes

888.3060 MQP – Spinal intervertebral body fixation orthosis

Predicate Devices

Alphatec Spine Novel VBR Spinal System (K050553) Globus Medical NIKO Corpectomy Spacer (K072465) Verticor Samson Corpectomy Cage (K091426)

Device Description

Intended Use

Choice Spine VBR System

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510(k) Summary (continued)

Materials

The Choice Spine Vertebral Body Replacement (VBR) System is manufactured from Polyetheretherketone (PEEK OPTIMA® from Invibio®) per ASTM F2026. Integral radiopaque markers are manufactured from tantalum per ASTM F560.

Technological Characteristics

The Choice Spine Vertebral Body Replacement (VBR) System consists of implant devices with a range of depths, widths, heights, & angles of lordosis similar to the identified predicate systems.

The Intended Use of the Choice Spine Vertebral Body Replacement (VBR) System is identical to the predicate systems. The Choice Spine Vertebral Body Replacement (VBR) System materials are similar to the predicate systems.

Substantial Equivalence

Documentation was provided that demonstrates the Choice Spine Vertebral Body Replacement (VBR) System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, materials, & performance. Mechanical testing was performed according to the guidelines outlined in ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression" & ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices". Testing parameters executed were static compression, dynamic compression, static torsion, dynamic torsion, subsidence, & expulsion.

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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 eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

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

Choice Spine, LP % Mr. Mark Bekkala 400 Erin Drive Knoxville, Tennessee 37919

APR - 5 2012

Re: K120570

Trade/Device Name: Choice Spine Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 19, 2012 Received: March 20, 2012

Dear Mr. Bekkala:

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 or any I 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice related adverse overals) (2) 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. Mark Bekkala

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 yours,

Eunel Keith

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

Enclosure

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Indication for Use Statement

510(k) Number (if known): _ K120570

Device Name: Choice Spine Vertebral Body Replacement (VBR) System

Indications for Use:

Prescription Use _ × (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)

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

K120570 510(k) Number.

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.