Search Results

The APEX Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The APEX Spine System is also indicated for pedicle screw fixation 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 APEX Spine System is also a hook and sacraliliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

The added Ø5.50mm and Ø6.0mm CoCr Spinal Rods are identical to the existing devices of the previously cleared APEX Spine System with recards to indications for use and function. The Ø5.50mm and Ø6.0mm CoCr Rods are available in various lengths and are designed for use with the previously cleared titanium alloy components of the APEX Spine System which can accept a Ø5.50mm and/or Ø6.0mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The Ø5.50mm and Ø6.0mm CoCr Rods will be labelled as components of the APEX Spine System.

The provided text describes a 510(k) submission for the APEX Spine System with CoCr Rods. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating the performance of an AI model or diagnostic device against acceptance criteria.

Therefore, the input does not contain the information necessary to complete the requested table and details regarding acceptance criteria and studies proving device performance in the context of AI or diagnostic accuracy studies. The document explicitly states:

• "No clinical studies were performed."
• The non-clinical tests were ASTM standards for mechanical properties of spinal implants.

Given this, I cannot fill out the requested table or provide information about:

1. Acceptance criteria and reported device performance (in terms of diagnostic accuracy/AI performance): Not applicable, as this is a mechanical spinal implant, not an AI or diagnostic device. Performance is typically assessed through mechanical testing and substantial equivalence, not diagnostic metrics.
2. Sample size for the test set and data provenance: No clinical/diagnostic test set was used. Mechanical testing involved specific constructs.
3. Number of experts used to establish ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document is purely about the regulatory clearance of a physical medical device (spinal rods) based on material specifications, intended use, and mechanical testing, demonstrating substantial equivalence to predicates.

Ask a specific question about this device