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The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.

The Theken VU VBR SYSTEM is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622), Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

The Theken VU VBR SYSTEM is comprised of rounded rectangular and rectangular cages with fenestrations and radii on all sides and toothed spikes which are used in combination with spacer components. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The provided document is a 510(k) summary for the Theken VU VBR SYSTEM, which is a vertebral body replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish acceptance criteria for device performance in terms of accuracy, sensitivity, or specificity.

Therefore, the document does NOT contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The 510(k) summary explicitly states: "Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have essentially the same precautions and contradictions for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details. Based on the design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis (adherence to GLP), Theken Surgical believes that sufficient evidence exists to reasonably conclude that the VU VBR SYSTEM is substantially equivalent to existing legally marketed devices."

The study that "proves the device meets the acceptance criteria" in this context refers to the comparison against predicate devices and mechanical testing, not a clinical study to establish diagnostic performance. The "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity but rather as conformity to the design, materials, and intended use of equivalent devices already on the market and adherence to good laboratory practices (GLP) for mechanical testing.

Since this is a medical device and not an AI/algorithm-based diagnostic tool, many of the requested fields are not applicable to this type of regulatory submission.

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