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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.

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The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization 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, kyphosis, spinal tumor, 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 (13 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.

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

Function: The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

The provided text describes the ODALYS™ Pedicle Screw System, a medical device, and its acceptance criteria as determined by the FDA's 510(k) clearance process.

Here's an analysis of the acceptance criteria and the "study" (non-clinical tests) used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "test set" in the context of human data. The testing performed was non-clinical, involving mechanical tests of the device. The sample size for these mechanical tests (e.g., number of screws or constructs tested for each configuration) is not provided in the summary.
• Data Provenance: The data provenance is from non-clinical laboratory testing (mechanical testing per ASTM standards). There is no information regarding country of origin or whether it's retrospective or prospective, as it pertains to physical device testing, not human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The "ground truth" for this device, in the context of the 510(k) submission, is its mechanical performance and material properties. This is established by adherence to recognized ASTM standards for medical devices, rather than expert consensus on a dataset. The results are compared to predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective mechanical testing results comparing the device to accepted standards and predicate device performance.

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

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ODALYS™ Pedicle Screw System is a physical implant, not an AI-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. The device is a physical implant; there is no AI algorithm associated with it.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Compliance with recognized industry standards (ASTM F1717 and ASTM F136).
• Substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and function, as demonstrated by meeting or exceeding the mechanical performance and material specifications of those predicates.

8. The Sample Size for the Training Set

This section is not applicable. The ODALYS™ Pedicle Screw System is a physical pedicle screw system, not an AI or machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reason as point 8. There is no training set for this device.

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