(233 days)
The Medtronic Sofamor Danek SPINAL MESH™ System is for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. The SPINAL MESH™ device is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.
The Medtronic Sofamor Danek SPINAL MESH™ device is a cylindrically shaped implantable device with open ends and a hollow core throughout its longitudinal axis. Pyramid shaped openings are built into the wall of the device. These openings and the hollow core allow grafting material to be placed inside the device to help achieve a solid fusion. The contoured ends of the SPINAL MESH™ device serve to grip the superior and inferior end plates, thus allowing expulsion resistance. The device is made from commercially pure titanium or titanium alloy conforming to such voluntary standards as ASTM F67 and ASTM F136 or the ISO equivalents 5832-2 and 5832-3, and is available in various sizes to match the patients' anatomical requirements. The SPINAL MESH™ device is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine. These systems include the ZPLATE-IITM Anterior Fixation System, the CD HORIZON® Spinal System, the TSRH® Spinal System, the DYNALOK™ CLASSIC Spinal System, and the Laurain DeWald Anterior Fixation System.
This document is a 510(k) summary for the Medtronic Sofamor Danek SPINAL MESH™ System. It describes the device, its intended use, and states that it was found "substantially equivalent" to previously cleared devices.
Based on the provided text, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why:
- No Acceptance Criteria: The document does not define any specific performance metrics (e.g., strength, durability, biocompatibility) or their corresponding acceptable thresholds for the SPINAL MESH™ System.
- No Study Details: There is no description of a study conducted to test the device's performance against any criteria. The statement "The Medtronic Sofamor Danek SPINAL MESH™ System was demonstrated to be substantially equivalent to similar previously cleared devices" indicates that the premarket notification relied on demonstrating equivalence to existing devices, rather than presenting a performance study with acceptance criteria.
- No Clinical or Standalone Performance Data: There is no mention of sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types and establishment for training sets. These are all elements typically found in studies designed to prove a device meets acceptance criteria.
Therefore, I cannot fill out the requested table or provide the detailed information about a study based on the given text.
This 510(k) summary focuses on demonstrating substantial equivalence, which is a regulatory pathway that often relies on comparison to predicate devices and adherence to relevant standards, rather than new, extensive performance studies with explicit acceptance criteria laid out in the submission itself.
§ 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.