Search Results

The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.

The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P is composed of a PEEK spacer with a radiopaque marker, a titanium alloy anterior plate and screws. The screws are inserted through the plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.

This device, the Synthes Zero-P, is an intervertebral fusion device. The provided text indicates that no clinical data was needed for this device. Therefore, a study demonstrating the device meets acceptance criteria via clinical performance data does not exist in this submission as it was not required.

Instead, the performance data cited is non-clinical, specifically "Bench testing results demonstrate that the Synthes Zero-P is substantially equivalent to the predicate devices." This implies that the acceptance criteria for this device were met through demonstrating equivalence in design, function, and materials to already approved predicate devices via non-clinical, benchtop testing, rather than through a clinical study with human subjects.

Given that no clinical study was performed, the following information cannot be provided from this submission:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device