The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or "teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. This system includes implants made of PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly defining and meeting performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily framed as demonstrating equivalence through mechanical testing, especially for worst-case designs. There is no mention of a study involving human-in-the-loop performance, expert ground truth establishment for diagnostic accuracy, or multi-reader multi-case studies as typically seen for AI/diagnostic devices. The acceptance criteria and "study" are focused on the mechanical performance of the implant.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance (Mechanical Testing)

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance
The primary acceptance criterion is substantial equivalence to the predicate devices (Choice Spine Vertebral Body Replacement (VBR) System K120570 and K162103, and Choice Spine Lumbar Spacer System K153107) in terms of mechanical performance, especially for the new, taller sizes (51-60mm) and considering the new additive manufacturing method. Specifically, the device must perform comparably to or better than the predicate devices in various mechanical tests to ensure its structural integrity and safety. Expected performance should meet or exceed the benchmarks established by the predicate devices and relevant ASTM standards for spinal implants. The document implies that the device must withstand the forces outlined in the ASTM standards (F2077 for Static/Dynamic Axial & Torsion, F2267 for Subsidence) without unacceptable failure or deformation. The general criterion is that the "performance data is substantially equivalent when compared to the primary predicate" and that the "subject device is substantially equivalent to the predicates listed" based on testing.	The "worst-case size of the additional implants proposed in this submission was subjected to mechanical testing." The results of these tests (Static Axial Compression, Static Torsion, Dynamic Torsion, Dynamic Compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion testing) "showed that the subject device is substantially equivalent to the predicates listed." Specific numerical results or comparison graphs are not provided in this summary document, only the conclusion of substantial equivalence.

Acceptance Criteria (Demonstrated Equivalence)

Reported Device Performance

The primary acceptance criterion is substantial equivalence to the predicate devices (Choice Spine Vertebral Body Replacement (VBR) System K120570 and K162103, and Choice Spine Lumbar Spacer System K153107) in terms of mechanical performance, especially for the new, taller sizes (51-60mm) and considering the new additive manufacturing method. Specifically, the device must perform comparably to or better than the predicate devices in various mechanical tests to ensure its structural integrity and safety. Expected performance should meet or exceed the benchmarks established by the predicate devices and relevant ASTM standards for spinal implants. The document implies that the device must withstand the forces outlined in the ASTM standards (F2077 for Static/Dynamic Axial & Torsion, F2267 for Subsidence) without unacceptable failure or deformation. The general criterion is that the "performance data is substantially equivalent when compared to the primary predicate" and that the "subject device is substantially equivalent to the predicates listed" based on testing.

The "worst-case size of the additional implants proposed in this submission was subjected to mechanical testing." The results of these tests (Static Axial Compression, Static Torsion, Dynamic Torsion, Dynamic Compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion testing) "showed that the subject device is substantially equivalent to the predicates listed." Specific numerical results or comparison graphs are not provided in this summary document, only the conclusion of substantial equivalence.

Important Note: This device is a physical implant, not an AI/diagnostic software. Therefore, the typical acceptance criteria and study methodologies for AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, human reader improvement) do not apply to this submission. The "study" here refers to non-clinical mechanical testing.

Study Details (Mechanical Testing)

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

Sample Size: Not explicitly stated for each mechanical test, but typically, mechanical testing for medical implants involves a small number of samples (e.g., n=3 or n=5) per test condition to demonstrate compliance with standards and equivalence.
Data Provenance: Not explicitly stated, but implies lab-based mechanical testing of manufactured implant samples. No country of origin for "data" in the sense of patient data, as this is a mechanical test. The testing is non-clinical/pre-clinical. It is not retrospective or prospective in the clinical sense.

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

N/A. This is mechanical testing of a physical device against engineering standards, not a diagnostic or AI device requiring expert interpretation of medical images or data. Ground truth is established by the specifications of the device and the mechanical properties derived from experiments.

4. Adjudication method for the test set:

N/A. Adjudication is not applicable as this is mechanical testing, not a diagnostic interpretation or clinical outcome assessment.

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:

N/A. This is a physical implant device, not an AI or diagnostic software. Therefore, no MRMC study or human reader assistance is relevant.

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

N/A. This is a physical implant device. The "standalone performance" is its mechanical integrity under various loads without human interaction.

7. The type of ground truth used:

Engineering specifications and ASTM standards (e.g., ASTM F2077, ASTM F2267). The "ground truth" for this device's performance is its ability to meet the mechanical strength, durability, and subsidence requirements as defined by recognized engineering standards and to demonstrate similar or superior performance to its predicate devices.

8. The sample size for the training set:

N/A. This is a physical implant, not a software or AI device that requires a "training set" in the machine learning sense.

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

N/A. Not applicable for this type of device.

Summary

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

September 15, 2017

Choice Spine Kim Finch Manager Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37924

Re: K171686

Trade/Device Name: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MOP Dated: August 16, 2017 Received: August 17, 2017

Dear Ms. Finch:

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171686

Device Name

Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✖ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date:	September 13, 2017
Sponsor:	Choice Spine, LP400 Erin DriveKnoxville, TN 37919
Phone:	865-246-3333
Fax:	865-246-3334
ContactPerson:	Kim Finch, Manager of Regulatory Affairs
ProposedProprietaryTrade Name:	Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
Product Class:	Class II
ClassificationName:	888.3060 - Spinal Intervertebral Body Fixation Orthosis
CommonName:Device	Spinal Vertebral Body Replacement Device
Product Code:	MQP
Purpose ofSubmission:	The purpose of this submission is to gain clearance for additional sizes of theChoice Spine Hawkeye™ Vertebral Body Replacement (VBR) System implantfamily in Titanium using a new method of additive manufacturing. The ChoiceSpine Vertebral Body Replacement (VBR) System has been cleared by the FDAin PEEK (K120570) and in Titanium (K162103).
DeviceDescription:	The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System iscomposed of implant components which have a basic oval/trapezoidal shapewith a hollow center for placement of bone graft. The superior and inferiorsurfaces have ridges, or "teeth" for resisting migration. The replacementimplants, "spacers", are available in an assortment of heights and in multipleangles of lordosis to accommodate different anatomic requirements. Thissystem includes implants made of PEEK (ASTM F2026) with Tantalum markers(ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).
Intended Use:	The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System isintended 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 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System isintended for use with supplemental fixation and is to be used with autogenousand/or allogeneic bone graft comprised of cancellous and/or corticocancellousbone graft to facilitate fusion.

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The implant components are available in two material varieties: Materials: polyetheretherketone (PEEK-OPTIMA® LT1, Invibio®) per ASTM F2026 with integral radiopaque markers manufactured from tantalum per ASTM F560, and titanium alloy (Ti-6Al-4V ELI) which conforms to ASTM F136 or ASTM F3001. All chosen materials are commonly used in medical devices. The implants will be provided non-sterile, but will be steam sterilized before use.

Substantial

Equivalence: The current subject devices in this submission are equivalent to the Choice Spine Vertebral Body Replacement (VBR) System K120570 (primary) and K162103, Choice Spine Lumbar Spacer System K153107 as additional predicates. The predicate devices are equivalent in principle of operation, indications for use, material, biocompatibility, manufacturing methods/ post processing steps, sterilization method, stabilization method, anatomic location and approach, product code and classification, and footprints (length & width). The additional taller height sizes in this submission, along with the new additive manufacturing method per ASTM F3001 and slight design change of being more trapezoidal and having window cutouts, introduce a new worst case for design. The performance data is substantially equivalent when compared to the primary predicate.

Conclusion: The additional implants proposed in this submission are identical in: Principle of Operation, Indications for Use, Biocompatibility, Sterilization and Stabilization Method, Anatomic Location and Approach, Intended Use, Product Code and Classification, and Footprints (Length & Width) to the previously cleared implants in this family.

The addition of the taller heights (51-60mm) represents a new worst case implant design along with a change in manufacturing method. Therefore, the worst-case size of the additional implants proposed in this submission was subjected to mechanical testing, which is discussed in detail in section 22, and results (along with the comparison in section 14.1) showed that the subject device is substantially equivalent to the predicates listed.

Non-clinical The non-clinical testing performed was Static Axial Compression, Static Testing Torsion, Dynamic Torsion, Dynamic Compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion testing.

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.