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The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoracolumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

The Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System) is a vertebral body replacement system, intended for use as an aid in spinal fusion. The SupStance VBR System consists of the SupStance VBR implant and the associated instrumentation required for implantation of the device. The SupStance VBR implant is a cage constructed of fused hollow cylindrical tubes with integral endcaps and open sides for introduction of bone graft material and bone reconstruction. The SupStance VBR cages are available in three diameters (22mm, 25mm, 28mm) and cover a range of heights from 35mm to 55mm with a total fixed sagittal angle of 5°.

The SupStance VBR cages are fabricated from poly-ether-ether-ketone (PEEK) and include markers made from titanium alloy. The implants are provided non-sterile and will be implanted via an antero-lateral approach.

The provided text describes the 510(k) summary for the Creaspine SupStance Vertebral Body Replacement System. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness related to AI or human-in-the-loop performance.

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is a different type of evaluation.

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document refers to "Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing)" and states "The data collected confirms that the mechanical properties of the proposed SupStance VBR System are comparable to those of the predicate devices." However, specific quantitative acceptance criteria or reported performance values are not provided.
2. Sample size used for the test set and data provenance: No test set related to diagnostic or AI performance is mentioned. The mechanical testing details do not include sample sizes in this summary.
3. Number of experts and their qualifications: Not applicable, as there's no diagnostic or AI performance study described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the "ground truth" would be established engineering standards or predicate device performance.
8. Sample size for the training set: Not applicable, as no AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

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