Search Results

The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM™ Spine System components are designed to accept a 6.35mm rod and are available in various geometries and sizes. The EXPEDIUM™ Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification.

The provided text is a 510(k) summary for a medical device called the "EXPEDIUM™ Spine System." This document is a regulatory submission to the FDA for a medical device and describes its intended use and materials. It does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study methodologies that would be typical for proving a device meets acceptance criteria in the manner requested.

The document states:

• "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification."

This indicates that mechanical performance data according to a specific ASTM standard (F 1798) was provided to the FDA. However, the exact acceptance criteria, the specific test results, the sample sizes for these tests, or any details about clinical studies (which would involve human readers, ground truth, etc.) are not present in this 510(k) summary. These summaries typically focus on device description, intended use, and substantial equivalence to predicate devices, rather than detailed study results.

Therefore, I cannot populate the requested table and answer the questions based solely on the provided text, as the information required to do so is not present. The document focuses on regulatory compliance based on mechanical testing and comparison to predicate devices, not on a clinical performance study with human readers or image analysis.

Ask a specific question about this device