(30 days)
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new worst-case device. | Finite element analysis demonstrated that added components would not result in a new worst-case device. |
| Substantial equivalence to predicate devices (K112664 and K091088). | Results from finite element analysis demonstrated that the subject devices are substantially equivalent to the referenced predicates. |
| Compliance with ASTM F2077 (for FEA validation). | Finite element analysis method has been validated to testing performed per ASTM F2077. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention a test set in the traditional sense of a clinical or observational study with human participants. The "test" here refers to the validation of a computational method.
- Sample size for the test set: Not applicable, as detailed above.
- Data provenance: Not applicable. The "study" is a finite element analysis, meaning it's a computational simulation rather than an empirical study gathering data from a specific population or geographic region.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There's no mention of experts establishing ground truth for a test set in this context.
- Ground truth in this study: The "ground truth" for the finite element analysis (FEA) is the established engineering principles and material properties used in the simulation, and its validation against testing performed per ASTM F2077. This is a technical standard rather than an expert consensus.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission concerns an intervertebral body fusion device, not an AI-powered diagnostic or interpretive system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this engineering analysis is based on established engineering principles, material properties (PEEK Zeniva ZA-500, Tantalum alloy), and validation against a recognized industry standard (ASTM F2077). It is not an expert consensus, pathology, or outcomes data in the biological sense. The outcome of the FEA is whether the new configurations maintain mechanical integrity and don't create a "new worst-case device" compared to the predicates.
8. The Sample Size for the Training Set
Not applicable. This is an engineering analysis of a physical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set in this context.
§ 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.