Search Results

Trinity SPMA Pedicle Screw System is 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 deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

The Single Planar Multi Axial (SPMA) Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies. The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60° from the midline.

The provided text is a 510(k) summary for a medical device (Trinity Orthopedics, LLC's Single Planar Multi Axis (SPMA) Pedicle Screw System). It describes the device's intended use, classification, and equivalence to a predicate device.

However, this document does not contain any information about acceptance criteria or a study designed to prove the device meets such criteria.

The 510(k) process for this type of device (a Class II orthopedic implant) typically relies on demonstrating substantial equivalence to a previously legally marketed predicate device. This is primarily achieved through:

• Comparison of Technical Characteristics: Showing that the new device has the same intended use, operating principle, basic design, materials, and sterile presentation as the predicate.
• Performance Testing (Bench Testing): Mechanical and often biocompatibility testing to ensure the device performs as expected and is safe. This testing does not typically involve clinical studies with human participants to establish clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot populate the requested table or answer the questions related to clinical study design, ground truth, expert adjudication, or reader performance, as this information is not present in the provided 510(k) summary. The document is concerned with demonstrating equivalence to a predicate device, not with proving specific diagnostic or therapeutic performance metrics through a clinical study as the prompt implies.

Ask a specific question about this device