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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

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.

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