(30 days)
The NIKO™ Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO™ Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The NIKO™ Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The NIKO™ Corpectomy Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of the device will grip the endplates of the adjacent vertebrae to resist expulsion.
NIKO devices are made from radiolucent polymer, and titanium alloy or tantalum as specified in F2026, F136, F1295, and F560.
The provided text is a 510(k) summary for the NIKO Corpectomy Spacer. It describes the device, its intended use, and states that performance data from mechanical testing in accordance with FDA guidance is presented. However, it does not include specific acceptance criteria, reported device performance metrics in a table, details of a study proving the device meets these criteria, or information about sample sizes for test/training sets, ground truth establishment, or multi-reader multi-case studies.
Therefore,Based on the provided text, I cannot complete the table of acceptance criteria and device performance, nor can I provide answers to most of the requested questions. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results against specific criteria.
Here's what can be extracted from the text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The document states "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." However, it does not explicitly list the acceptance criteria used in this testing or the specific performance results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The document refers to "mechanical testing," which typically involves material and device testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable/available. The device is a physical implant, and the performance data described is mechanical testing, not a diagnostic or prognostic algorithm requiring expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/available for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/available. The device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/available. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable/available. For mechanical testing, the "ground truth" would be engineering specifications and standards, not clinical ground truth.
8. The sample size for the training set:
This information is not applicable/available. The device is a physical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/available for the same reasons as point 8.
Summary of what is available from the text:
- Device Name: NIKO™ Corpectomy Spacer
- Intended Use: Vertebral body replacement device for the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended to be used with supplemental spinal fixation systems.
- Performance Data: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." (No specific details of the results or acceptance criteria are provided in this summary).
- Basis of Substantial Equivalence: Similar to the predicate device, Sustain Radiolucent Spacer (K040284), with respect to indications for use, material, principles of operation, and performance.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.