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The Advanced LumFix Spinal Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Advanced Lumfix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rod connectors and a crosslink linking mechanism. The Advanced Lumfix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Advanced 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.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

The document is an FDA 510(k) clearance letter for the "Advanced LumFix Spinal Fixation System." It primarily addresses the device's substantial equivalence to previously marketed predicate devices, its indications for use, and general regulatory compliance.

Specifically, the document mentions:

• Device Name: Advanced LumFix Spinal Fixation System
• Regulation Number: 21 CFR 888.3070 (Thoracolumbosacral Pedicle Screw System)
• Regulatory Class: Class II
• Indications for Use: Posterior, noncervical pedicle fixation as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Material: Titanium alloy (Ti-6A1-4V ELI) with a cobalt-chromium-molybdenum rod option.
• Non-clinical testing: Mechanical testing was performed in accordance with ASTM F1798 and ASTM F1717-11/18/21 (Static and Dynamic tests). This testing was to demonstrate equivalence to predicate devices, not to meet specific performance thresholds for a new function or AI component.
• Conclusion: The device is substantially equivalent in design, materials, indications, and performance to predicate devices.

There is no mention of:

• A table of acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity).
• Sample sizes for test or training sets for an AI/algorithm study.
• Data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• MRMC studies, human reader improvement, or effect sizes.
• Stand-alone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for training data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The device described is a physical spinal fixation system, not an AI or software device that would typically have performance metrics and studies as you've outlined.

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