SpineFab® 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 turnor or trauma (i.e. fracture). The VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

Device Description

The SpineFab® VBR implant is a non-custom implant. The SpineFab® VBR Implants consist of 48 different variations and each one of six different configurations (Small Parallel, Medium Parallel, Large Parallel, Small Lordotic, Medium Lordotic, and Large Lordotic) with the only difference on each configuration being the height. This device is manufactured using polyetherketoneketone (PEKK) polymer using additive manufacturing and contains tantalum radiographic markers.

The implants have an open shaft to allow for the placement of allograft or autograft. The implants have several other features:

Notches that are an aid to implant insertion,
Tantalum markers which allow for easy radiographic visualization, and
Teeth-like structures meant to engage the vertebral endplates for stabilization in vivo.

SpineFab® Vertebral Body Replacement (VBR) System is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validated.

AI/ML Overview

This document describes the premarket notification (510(k)) for the SpineFab® Vertebral Body Replacement (VBR) System. It focuses on demonstrating the device's substantial equivalence to existing predicate devices, primarily through bench testing.

Here's an analysis of the acceptance criteria and study detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of quantified acceptance criteria with specific performance values for the SpineFab® VBR System. Instead, it states that performance testing was conducted according to recognized ASTM and ISO standards, and the results "were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards" for biocompatibility and that mechanical testing was performed according to ASTM standards for compression, torsion, subsidence, and expulsion.

For the purpose of this analysis, we can infer the acceptance criteria are adherence to these established standards.

Feature/Test	Acceptance Criteria (Inferred from standards)	Reported Device Performance
Material Biocompatibility	"Within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards." These ISO standards cover: - ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - ISO 10993-5: Tests for in vitro cytotoxicity - ISO 10993-6: Tests for local effects after implantation - ISO 10993-10: Tests for irritation and skin sensitization - ISO 10993-11: Tests for systemic toxicity - ISO 10993-18: Chemical characterization of materials	Test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards.
Mechanical Performance (Compression, Torsion, Subsidence, Expulsion)	Testing performed according to: - ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices" - ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression" - ASTM draft F-04.25.02.02: Static Expulsion (The specific acceptance limits from these standards are not detailed in the document but are implied to be met)	Mechanical testing evaluations were substantially equivalent to predicate devices, having been evaluated according to ASTM standards for static and dynamic axial compression bending, static and dynamic torsion, static subsidence, and static expulsion.
Sterilization	Sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities." (Implies meeting sterility assurance levels outlined in this standard.)	The device is shipped non-sterile, and the sterilization recommendations in the IFU are according to ANSI/AAMI ST79 and "have been validated."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Mechanical Testing: The document mentions a specific test specimen design (15x12x50 mm) considered the "worst case design" for compression, torsion, subsidence, and expulsion testing. However, the number of specimens tested ("sample size") for each mechanical test is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given that this is bench testing, "provenance" typically refers to the testing laboratory and design/manufacturing controls rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable in the context of this 510(k) submission. The document describes bench testing of a physical device, not a diagnostic or AI device that relies on expert interpretation to establish ground truth for a test set. The "truth" for mechanical properties is determined by the physical outcome of the tests against engineering specifications and validated standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing involves physical measurements against engineering standards and not human interpretation of complex data (like medical images), there is no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device submission. This study type is typically used for diagnostic devices (e.g., AI algorithms for image interpretation) to show how an AI system impacts human reader performance. The SpineFab® VBR System is an implantable surgical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was not performed, nor is it relevant to this device. This concept applies to AI algorithms. The SpineFab® VBR System is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is established by engineering and material science standards and specifications. Specifically:

Biocompatibility: Adherence to established ISO 10993 series standards, which define acceptable biological responses.
Mechanical Performance: Adherence to established ASTM standards (F2077, F2267, and a draft F-04.25.02.02), which define acceptable mechanical properties and testing methodologies for intervertebral body fusion devices.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device. The SpineFab® VBR System is a physical implant, not a software algorithm that undergoes machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for a software algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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

July 10, 2015

Oxford Performance Materials Ms. Leigh Avres Director, Scientific and Regulatory Affairs 30 South Satellite Road South Windsor, Connecticut 06074

Re: K142005

Trade/Device Name: SpineFab® 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: June 3, 2015 Received: June 12, 2015

Dear Ms. Ayres:

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 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

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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 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. 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 Industry and Consumer Education 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 yours,

Lori A. Wiggins -S

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

Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142005

K142005 Page 1 of 1

Device Name

SpineFab® 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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5 - SpineFab® VBR 510(k) Summary as Required by Title 21 CFR 807.92(c) for K142005

510(k) Submitter: Oxford Performance Materials, Inc. P.O. Box 585 30 South Satellite Road South Windsor, CT 06074 1-860-698-9300

Contact Person: Leigh Ayres, Director of Scientific and Regulatory Affairs Date of 510(k) summary statement preparation: July 9, 2015 Proprietary name: SpineFab® Vertebral Body Replacement (VBR) System Common or Usual Name: Spinal intervertebral body fixation orthosis Classification: 21 CFR 888.3060 Review Panel: Orthopedic Medical Device Classification: Class 2 Product Code: MQP Predicate Devices: the Choice Spine Vertebral Body Replacement (VBR) System (K120570) (primary) and the Pioneer Surgical Technology, Inc. MaxFuse VBR System (K131724).

Description of the Device

The implants have an open shaft to allow for the placement of allograft or autograft. The implants have several other features:

Notches that are an aid to implant insertion,
Tantalum markers which allow for easy radiographic visualization, and
Teeth-like structures meant to engage the vertebral endplates for stabilization in vivo.

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Intended Use Statement

SpineFab® 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 autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

Biocompatibility

Biocompatibility tests were selected according to the FDA guidance document: "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (1995) and the test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards.

Performance Testing - Bench Testing

COMPRESSION, TORSION, SUBSIDENCE, AND EXPULSION

This testing was required by UCM072518 "FDA Guidance for Industry and FDA Staff Spinal System 510(k)s" dated 2004. Based on the 2004 guidance, the test specimen design (15x12x50 mm) was the worst case design because it was the "tallest with the smallest cross sectional area." This was confirmed utilizing finite element analysis.

Testing was performed according to:

a. ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices,"
ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence b. of Intervertebral Body Fusion Device Under Static Axial Compression," and
ASTM draft F-04.25.02.02: Static Expulsion C.

Comparison of Technological Characteristics with Predicate Devices

The SpineFab® VBR device is substantially equivalent in safety and effectiveness to two other predicate devices cleared by the FDA under 21 CFR 888.3060 spinal intervertebral body fixation orthosis. Those two predicate devices are: the Choice Spine Vertebral Body Replacement (VBR) System (K120570) and the Pioneer Surgical Technology, Inc. MaxFuse VBR System (K131724). Information about the two predicate devices described in this section 5 of this 510(k) submission was obtained from the 510(k) summary documents posted on the FDA 510(k) premarket notification access database.

The intended use statements are substantially equivalent because the scopes of the predicate intended use statements include the intended use statement for the subject device in terms of the location in the spine (T1-L5) and function (vertebral body replacement).

Section 5 – SpineFab VBR 510(k) Summary 2015Jul09-1 Page 2 of 3

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The two predicates and the subject devices are substantially equivalent in that they are made from Polyaryletherketone (PAEK) polymers. The two predicates are made from polyetheretherketone (PEEK) polymer and the subject device is made from polyetherketoneketone (PEKK) polymer.

The basic design of the two predicates is substantially equivalent regarding sizes, configurations, toothed surfaces, and the acceptance of bone graft material.

The mechanical testing evaluations were substantially equivalent in that the two predicates and the subject device were evaluated according to ASTM standards for static and dynamic axial compression bending, static and dynamic torsion, static subsidence, and static expulsion.

Conclusion

Based on the information provided in the submission, including comparison and bench testing; the SpineFab® VBR device was determined to be substantially equivalent in terms of safety and effectiveness to predicates devices cleared by the FDA.

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.