Search Results

The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiosraphic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.

The Dymaxeon Spine System is a posterior pedicle screw system designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, connectors and fasteners. The implants are sold sterile.

The provided text is a 510(k) summary for the Dymaxeon Spine System. It focuses on the mechanical testing and substantial equivalence of the device, particularly the new eCarbon rods and rod connectors, to predicate devices. It does not describe a study involving an AI component or a device that has acceptance criteria related to performance metrics like sensitivity, specificity, or accuracy in a diagnostic context.

Therefore, I cannot extract the information required by your prompt, as it is designed for a medical device that utilizes AI and has performance-based acceptance criteria, which this document does not contain.

The document describes the device, its indications for use, materials, and mechanical testing results to demonstrate substantial equivalence, but it does not include:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI outputs.
2. Sample size used for a test set in the context of diagnostic performance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone (algorithm-only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data) for diagnostic tasks.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Ask a specific question about this device