Search Results

Mikron Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the ittachment of a solid fusion.

Mikron Spinal Fixation System is also intended to provide immobilization 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 the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Proposed Device is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods (Straight and pre-bent) and setscrews. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the Mikron Spinal Fixation System. This type of submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of clinical study typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, the information required to answer your questions regarding acceptance criteria and performance studies for an AI/SaMD product (such as a table of accuracy, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

This document details:

• The device's intended use (spinal fixation)
• Its material (titanium alloy)
• Its design (pedicle screws, rods, setscrews)
• Its technological characteristics compared to predicate devices
• Non-clinical performance testing: static compressive, torsion, and dynamic compressive tests according to ASTM F1717; torsion and pullout tests for screws according to ASTM F543; axial and torsional gripping capacity according to ASTM F1798; and static and dynamic 4-point bending according to ASTM F2193. These are mechanical tests to ensure the physical properties and strength of the implant, not a study of algorithm performance.
• Risk Analysis.

The key takeaway is that for a traditional hardware medical device like a spinal fixation system, "acceptance criteria" are typically met through mechanical and material testing to established industry standards (e.g., ASTM standards) and comparison to predicate devices, rather than the kind of clinical performance study with human readers and ground truth data that would be relevant for an AI/SaMD product.

In summary, the document does not contain the information needed to answer the specific questions about AI/SaMD acceptance criteria and study data.

Ask a specific question about this device