(76 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, Aspect Systems.
When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, 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 the 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, or Streamline MIS Systems.
When used as a vertebral body replacement (VBR) device (C-Plus, Rotate. Bullet-Tip, T-Plus, Contact, CrossFuse, 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 turnors 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 the Quantum Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). 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 is a line extension to add an additional design to the currently available C-Plus implants. The subject implants are for Cervical Intervertebral Body Fusion only. Class I (exempt) orthopedic manual surgical instruments are also available.
The provided text describes a 510(k) Summary for an Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical trials or AI/algorithm performance studies. Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and AI performance are not applicable to the information provided.
Here's an analysis based on the available text:
Acceptance Criteria and Device Performance
The device demonstrates substantial equivalence through pre-clinical mechanical testing. The acceptance criteria are implicitly met by demonstrating that the mechanical strength of the subject device is substantially equivalent to a legally marketed predicate device and sufficient for its intended use.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | - Static compression strength in accordance with ASTM F2077. |
- Static torsion strength in accordance with ASTM F2077.
- Static subsidence strength per ASTM F2267.
- Static expulsion strength per Draft Standard Z8423Z.
- Overall mechanical strength sufficient for intended use and substantially equivalent to a predicate device. | - "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."
- Specific numerical results from these tests are not provided in the summary but were performed.
- "Any differences [between subject and predicate devices] were not considered significant based on mechanical bench testing." |
Study Details (Not Applicable for this 510(k) Summary)
The provided text describes a pre-clinical bench testing study focusing on mechanical strength, not clinical performance, AI/algorithm performance, or human reader effectiveness. Therefore, the following items are not relevant to this submission:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing mechanical testing, not a dataset of medical images or patient records. The provenance is internal lab testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement against ASTM standards, not expert clinical interpretation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 medical device (implant) submission, not an AI/imaging software submission.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (implant) submission, not an AI/imaging software submission.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the mechanical performance testing is established by ASTM standards and measurements of physical properties like compression, torsion, subsidence, and expulsion.
- The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The study conducted was a pre-clinical mechanical bench testing of the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System. This involved performing various tests to assess the device's static compression, static torsion, static subsidence, and static expulsion characteristics. The results of these tests were compared against established ASTM standards (F2077, F2267) and a draft standard (Z8423Z), as well as against a legally marketed predicate device. The conclusion was that the device's mechanical strength is substantially equivalent to the predicate and sufficient for its intended use.
§ 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.