When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

Device Description

The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System consists of a variety of different footprints and heights which enable the surgeon to choose the implant best suited to an individual's pathology and anatomical condition. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine and adequate compression of the implant. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. The components are manufactured from a radiolucent polymer (PEEK Optima®) in order to allow radiographic imaging inside the implant to evaluate fusion status. The purpose of this submission to add implant configurations to the CrossFuse II line of implants, intended for lumbar IBF and VBR use. Class I (exempt) orthopedic manual surgical instruments, including the Clarity Retractor System, are also available for use with the System.

AI/ML Overview

The provided document describes a medical device, the Pioneer Surgical Technology, Inc. Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System, and its clearance through the 510(k) pathway. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study with predefined acceptance criteria for device performance as would be seen for AI/ML devices or novel therapies.

Therefore, the typical acceptance criteria and study design elements you've requested (e.g., sample size, expert qualifications for ground truth, MRMC studies, standalone performance) are not applicable in the context of this device and submission.

Here's an breakdown based on the information provided, explaining why certain elements are not present:

1. Acceptance Criteria and Reported Device Performance

For this medical device, substantial equivalence to predicate devices is the primary "acceptance criterion" for regulatory clearance. The performance is assessed through pre-clinical mechanical testing rather than clinical outcomes or diagnostic accuracy metrics.

Acceptance Criteria (based on 510(k) pathway)	Reported Device Performance (from submission)
Mechanical Strength Substantial Equivalence	"Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to a legally marketed predicate and sufficient for the intended use."
Biocompatibility	Implied by the use of ASTM F2026 Polyetheretherketone (PEEK) and ASTM F560 tantalum or ASTM F136 Titanium alloy radiographic markers, which are standard, biocompatible materials for implants. This is inherent in the material selection, not a separate performance metric listed for the device itself beyond material specification.
Functionality	The device is designed to facilitate intervertebral body fusion and vertebral body replacement, and to restore height and biomechanical integrity. Its performance is directly tied to its mechanical properties and intended use. The clinical outcome (e.g., fusion rate) is dependent on many factors, including surgical technique and patient physiology, and is not a direct "performance" of the device itself measured in this specific pre-clinical context. The acceptance is based on the expectation that its mechanical properties support this function as well as predicate devices do.
Safety and Effectiveness	The 510(k) clearance implies that the device is deemed safe and effective for its intended use due to its substantial equivalence to legally marketed predicate devices, which are presumed to be safe and effective. "There are no significant differences between the subject and predicate devices which would adversely affect the use of the product. Any differences were not considered significant based on mechanical bench testing."

The Study that Proves the Device Meets Acceptance Criteria

The study described is a pre-clinical mechanical bench testing study.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices, but multiple tests (static compression, static torsion, static subsidence, static expulsion) were performed on representative samples of the device configurations. The emphasis is on demonstrating equivalence across configurations rather than statistical significance from a large sample.
- Data Provenance: This is bench test data, generated in a laboratory setting, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering standards (ASTM F2077, ASTM F2267, Draft Standard Z8423Z) and comparisons to predicate device performance, not expert clinical interpretation. The expertise lies in mechanical engineering and regulatory compliance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no human adjudication for mechanical bench testing results; performance is measured against established engineering standards and predicate device data.
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 device is a physical implant, not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the mechanical testing is defined by established ASTM standards for mechanical performance of spinal implants, and the mechanical performance of legally marketed predicate devices. The goal is to demonstrate that the subject device performs equivalently to these standards and predicates under various mechanical loads.
The sample size for the training set: Not applicable. There is no training set for a physical medical implant device.
How the ground truth for the training set was established: Not applicable.

In summary, the regulatory approval for this Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System was based on demonstrating substantial equivalence to existing, legally marketed predicate devices through pre-clinical mechanical bench testing against recognized industry standards. The detailed clinical trial and AI/ML validation methodologies you inquired about are not relevant to this specific device submission type.

Summary

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	510(k) Summary Pursuant to 21 CFR 807.92
Sponsor:	Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USAContact: Emily Downs, Sarah McIntyrePh: (906) 225-5602 Fx: (906) 226-4459Prepared: March 25, 2014
Name:	Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Trade names:	C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, & CrossFuse II
Common name:	Intervertebral Body Fusion Device/ Vertebral Body Replacement Device
Classifications:	21 CFR 888.3080 - Class II .21 CFR 888.3060 - Class II
Product Codes:	MAX, ODP, MQP
Panel/ Branch:	Orthopaedic and Rehabilitation Devices Panel; Panel Code 87
Predicates:	Pioneer IBF/VBR System K112496 &K133623Pioneer IBF System K073177Pioneer VBR System K043206 & K061151NuVasive CoRoent System (K071795)
Description:	The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) Systemconsists of a variety of different footprints and heights which enable thesurgeon to choose the implant best suited to an individual's pathology andanatomical condition. Supplemental anterior and/or posterior fixation isintended for use with the device to ensure stability of the spine andadequate compression of the implant. The IBF/VBR implants may beimplanted via a variety or open or minimally invasive approaches,including anterior, lateral, posterior and oblique.The components are manufactured from a radiolucent polymer (PEEKOptima®) in order to allow radiographic imaging inside the implant toevaluate fusion status.The purpose of this submission to add implant configurations to theCrossFuse II line of implants, intended for lumbar IBF and VBR use.Class I (exempt) orthopedic manual surgical instruments, including theClarity Retractor System, are also available for use with the System.

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Intended Use: When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

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Pre-ClinicalPerformance Data:	For a determination of substantial equivalence, static compression andstatic torsion testing was performed in accordance with ASTM F2077. Inaddition, static subsidence testing per ASTM F2267 and static expulsiontesting per Draft Standard Z8423Z were performed. Mechanical testingshowed that the mechanical strength of the subject system is substantiallyequivalent to a legally marketed predicate and sufficient for the intendeduse.
	Additional sizes and configurations outside the range of previously cleareddevices were justified based on an anatomic rationale.
Materials:	The Pioneer IBF/VBR System implants are composed of ASTM F 2026Polyetheretherketone (PEEK) with ASTM F560 tantalum or ASTM F 136Titanium alloy radiographic markers.
Summary ofTechnologicalComparison:	The subject implants are unique from the predicate CrossFuse II implantsin that they include a coronal taper or increased lordotic angle(hyperlordotic).
	This submission supports the position that the subject implants aresubstantially equivalent to previously cleared IBF/VBR devices. Thesubject and predicate devices are similar in terms of indications for use,composition, sterilization, packaging,materialtechnologicalcharacteristics, design features, and mechanical strength.
SubstantialEquivalence	There are no significant differences between the subject and predicatedevices which would adversely affect the use of the product. Anydifferences were not considered significant based on mechanical benchtesting.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608 Silver Spring, MD 20993-0002

March 27, 2014

Pioneer Surgical Technology. Incorporated Ms. Emily Downs Director. Regulatory and Clinical Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K133455

Trade/Device Name: Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX. ODP. MQP Dated: February 14, 2014 Received: February 18. 2014

Dear Ms. Downs:

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 mislcading.

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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Page 2 - Ms. Emily Downs

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 vour device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address -

http://www.fda.gov/McdicalDevices/Resourcesfor You/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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronald P. Jean -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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133455

Device Name

Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System

Indications for Use (Describe)

When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in paients who had six weeks of non-operative treatment. IBFs are with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level. such as Streamline OCT. SlimFuse, Cequence, PAC, or Aspect Systems.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Contraction of the For For For For For For For For For Contract Comments of the Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Formitriev.

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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 on last page.

510(k) Number (if known) K133455

Device Name

Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System

Indications for Use (Describe)

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System') is indicated for interverebral body fusion of the spine in skeletally mature patiented for use at either one level or two contiguous levels in the humbar spine, from L2 to S1, for the treatment of decement ve discase (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiosraphic studies. Lumbar IIIFFs are to be used in patients who have had six months of non-operative tecament. IBFs are designed for use with autogenous bour graft 10 facilitate fusion. 1895s are intended to be used with supplemental spinal fixation cleared level, such as Quantum. Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System,

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)

...

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 on last page.

510(k) Number (if known) K133455

Device Name

Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System

Indications for Use (Describe)

When used as a vertebral body replacement (VBR) device (C-Plus, Contact, CrossFuse, and CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System") is intended for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor of trauma of T1-L5) such as the Streamline TL Spinal Fixation System, Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CONTRACTOR COLLEGE FOR FOR EDAUSEIONLY AND THE FOR FOR FOR FOR FOR FOR FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Praitriev

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.