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ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• · Spondylolisthesis (Grade 3 and 4)
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• · Tumor
• · Pseudoarthrosis
• · Failed previous fusion

ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. ANAX M 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. ANAX™ 5.5 Spinal System components are supplied nonsterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAXTM 5.5 Spinal System implants.

This document is a 510(k) premarket notification for the ANAX™ 5.5 Spinal System, seeking FDA clearance for marketing. It does not describe a study involving an AI/Machine Learning device or any clinical performance studies that would involve acceptance criteria and device performance as typically understood for software/AI.

Therefore, I cannot extract the information required concerning acceptance criteria and a study proving a device meets them, because this document pertains to a traditional medical device (pedicle screw spinal system) and its substantial equivalence to previously cleared predicate devices through bench testing, not a digital health product with AI/ML components.

The "Performance Testing" section explicitly states: "ANAX™ 5.5 Spinal System was tested in a non clinical setting (bench testing) to assess mechanical performance of this device. Static mechanical tests (axial gripping capacity test, torque gripping capacity test) were performed according to ASTM F1798. The testing verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices."

This type of testing focuses on the physical properties and mechanical strength of the hardware, not on diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI/ML performance. There is no mention of a test set, ground truth established by experts, multi-reader multi-case studies, or training data for an algorithm.

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