(74 days)
CERVICAL INTERBODY FUSION DEVICE
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 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 and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous 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.
LUMBAR INTERBODY FUSION DEVICE
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 (DD) 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.
VERTEBRAL BODY REPLACEMENT
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 (TI-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 TI-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 system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique.
This document is a 510(k) premarket notification for the "Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System". It concerns the clearance for the use of allogenic bone graft with the existing C-Plus cervical intervertebral body fusion device.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific device performance metrics in numerical form. Instead, the basis for clearance is substantial equivalence to a predicate device (Pioneer IBF/VBR System K133455) and a literature analysis. The "performance" in this context refers to demonstrating that the expanded indication (use of allogenic bone graft) poses no new risks and is equivalent to the established performance with autogenous bone graft.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable and not explicitly stated. The submission relies on a "literature analysis of published clinical data" rather than a new test set generated for this 510(k). The literature analysis would have encompassed various studies, each with its own sample size.
- Data provenance: Not specified in terms of country of origin or whether the individual studies in the literature analysis were retrospective or prospective. The submission only states it's "published clinical data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This submission relies on a literature analysis, not a new study with a ground truth established by experts specifically for this submission. The "ground truth" (clinical outcomes) would have been established within the original published studies by the researchers and clinicians involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or adjudication process was performed for this 510(k) submission.
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 spinal implant device, not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a spinal implant device, not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly referred to in the literature analysis would be the clinical outcomes data from previously published studies on cervical interbody fusion devices using allogenic bone graft. This would include fusion rates, pain reduction, adverse events, etc.
8. The sample size for the training set
Not applicable. No new algorithm or model was trained for this submission. The device is a physical implant.
9. How the ground truth for the training set was established
Not applicable. No new algorithm or model was trained for this submission.
§ 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.