(73 days)
When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a pedicle screw fixation system, the SHIRAZ Systems are also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or as an adjunct to fusion in the reading and sacral spine: degenerative spondylolisthesis with deformities of the thoracic, lumbar, and sacral spine, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
When used as a posterior, noncervical hook, and/or sacral/iliac screws fixation system, or when used as a posterior, noncervical rod areas, we fixation system, the SHIRAZ Systems are as an bi-lateral anterior, and lordosis, fracture, loss of stability due to tumor, intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, Spinal Stenosis, Spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
The Spine Next SHIRAZ Anterior System is designed to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
All implants are manufactured from Titanium Alloy (Ti6A14V) meeting the requirements of ASTM F136/ISO 5832 or commercially pure Titanium (cpTi, Grade 4) meeting requirements of ASTM F67/ISO 5832.
The provided text describes a 510(k) premarket notification for the Spine Next SHIRAZ Anterior System. This document focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria.
Thus, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical evaluation.
- Sample size for the training set.
- How the ground truth for the training set was established.
However, the document does contain information about performance data from biomechanical testing, which is a common method for demonstrating the safety and effectiveness of implantable devices like spinal fixation systems.
Here's what can be extracted regarding performance data:
Performance Data Mentioned:
The document states: "Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798."
This indicates that the device's mechanical integrity and stability were evaluated through a series of tests designed to simulate the stresses it would experience in the human body.
- ASTM F1717: This standard (ASTM F1717-96(2001) "Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model") typically covers the in vitro static and dynamic characterization of spinal implant assemblies used for anterior corpectomy. It evaluates the mechanical performance of spinal implants, looking at properties like stiffness, fatigue strength, and resistance to permanent deformation.
- ASTM 1798: This standard likely refers to ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." This standard focuses on the connection mechanisms between different components of a spinal fixation system, ensuring they can withstand the forces without failure.
Limitations based on the provided text:
The provided 510(k) summary does not include the specific numerical acceptance criteria (e.g., minimum fatigue cycles, stiffness values) from these ASTM standards, nor does it present the actual test results of the SHIRAZ Anterior System against those criteria. It only states that the testing was performed in accordance with these standards. For a 510(k) submission, demonstrating adherence to established industry standards for mechanical performance is typically sufficient to show substantial equivalence for this type of device, as opposed to requiring clinical trial data found in PMAs.
§ 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.