(135 days)
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.
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.
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.
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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.
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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.
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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.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
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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.
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The sample size for the training set: Not applicable. There is no training set for a physical medical implant device.
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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.
§ 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.