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The LumFix Spinal Fixation System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The LumFix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rods and a crosslink linking mechanism.

The LumFix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. LumFix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.

The provided text describes a medical device submission, specifically a 510(k) premarket notification for the "LumFix Spinal Fixation System." This document is focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance through a clinical study for a novel AI/software device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

The document discusses:

• Device Name: LumFix Spinal Fixation System
• Regulation Number: 21 CFR 888.3070
• Regulation Name: Pedicle screw spinal system
• Regulatory Class: Class II
• Product Code: MNI, MNH
• Indications for Use: Spinal fusion for various acute and chronic instabilities/deformities of the thoracic, lumbar, and sacral spine in skeletally mature patients.
• Predicate Devices: Zenius™ Spinal System (K093104) and ANAX™ 5.5 Spinal System (K132101).
• Non-clinical testing: Mechanical testing according to ASTM F1717 and ASTM F1798 to demonstrate equivalence. This includes static (tension, compression, torsion) and dynamic (fatigue) tests.

This is a submission for a physical medical device (spinal fixation system) and relies on mechanical testing to prove substantial equivalence to existing devices, not a clinical study to establish performance against acceptance criteria for an AI or software-based medical device.

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