Search Results

The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ODALYS™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ODALYS™ Pedicle Screw System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.

The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.

The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

The provided text is a 510(k) premarket notification letter for the ODALYS™ Pedicle Screw System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it explicitly states, "No clinical studies were performed."

Therefore, based on the provided document, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted because such a study was not performed for this submission:

1. A table of acceptance criteria and the reported device performance: Not applicable as no clinical studies were performed.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical studies were performed.
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 as this is a mechanical device, not an AI-powered diagnostic tool, and no clinical studies were performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an AI-powered diagnostic tool, and no clinical studies were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical studies were performed.
8. The sample size for the training set: Not applicable as no clinical studies were performed.
9. How the ground truth for the training set was established: Not applicable as no clinical studies were performed.

Summary of Nonclinical Tests:

The document does mention nonclinical tests:

• Static and dynamic compression per ASTM F1717
• Static torsion per ASTM F1717

The conclusion is that "The results of this testing indicate that the ODALYS™ Pedicle Screw System is equivalent to predicate devices." This implies that the acceptance criteria for these nonclinical tests would have been maintaining comparable performance to the predicate device under these standardized testing conditions as defined by ASTM F1717. However, the specific quantitative acceptance criteria and reported performance metrics are not detailed in this summary.

Ask a specific question about this device