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When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® Spinal Screw System is 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 of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
• Degenerative spondylolisthesis; ●
• Trauma (i.e., fracture or dislocation); .
• . Spinal stenosis;
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
• Tumor , .
• Pseudoarthrosis; and/or .
• Failed previous fusion. .

The Extended VertiFlex® Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium conforming to ASTM F67, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimallyinvasive/percutaneous techniques, although the line extension which is a subject of this submission is designed specifically to facilitate MIS/percutaneous use. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. The modifications that are the subject of this submission consist of the addition of rod and screw components designed to more easily create multi-level constructs percutaneously, and screws having smaller diameters. Screws, rods, and instruments are offered non-sterile.

This 510(k) summary describes a spinal screw system, which is a physical device, not an AI/ML powered medical device. Therefore, the typical acceptance criteria and study design elements requested (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable in the context of AI/ML.

The provided document states:

• No clinical testing was conducted to support this submission. (Section 5.8)
• The determination of substantial equivalence was based on rigorous design control processes, comprehensive risk analysis, and non-clinical verification and validation tests. (Sections 5.6 and 5.7)

Therefore, I cannot provide the requested information related to AI/ML device acceptance criteria and studies, as this device is a traditional medical implant subject to different evaluation methods.

If you are looking for information about the non-clinical tests performed, the document generally states:
"Such verification and validation tests as were identified as appropriate to address the results of a risk analysis for the subject Extended VertiFlex® Spinal Screw System were completed, and all acceptance criteria were met." (Section 5.7). However, the specific acceptance criteria and detailed outcomes of these non-clinical tests are not provided in this summary.

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