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The 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

The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The 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. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 spinal System. The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 SPINAL SYSTEM is 2 years based on mechanical test result.

The provided text is a 510(k) summary for a spinal system, not an AI/ML device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these are typically relevant for AI/ML device submissions.

The document discusses substantial equivalence to a predicate device based on design, materials, mechanical performance, and intended use. The "performance justification" section states that no new mechanical testing was conducted because no new worst-case scenario was introduced. Instead, the mechanical strength was evaluated theoretically by comparing data of the subject device to the predicate devices.

Therefore, I cannot extract the requested information because it is not present in the provided text.

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