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The NuVasive XLX Interbody System is intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the XLX internal fixation, the system is intended for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. XLX interbody devices expanded to ≥20° lordosis must be used with the XLX internal fixation and additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.

The XLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive XLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The NuVasive XLX Interbody System is an expandable interbody system manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136 and ISO 5832-3, and nickel-cobaltchromium-molybdenum (MP35N) conforming to ASTM F562. XLX interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The XLX Interbody intervertebral fusion device is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The hollow core, or graft aperture, allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to aid in the promotion of a solid fusion. An internal fixation plate with bone screw manufactured from titanium alloy (Ti-6A1-4V ELI) conforming ASTM F136 or ISO 5832-3 and MP35N conforming to ASTM F562 may be affixed to the adjacent vertebral body to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screw, the device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine.

The provided text describes a 510(k) premarket notification for the NuVasive® XLX Interbody System, which is an intervertebral body fusion device. The document outlines the device's indications for use, technological characteristics, and performance data used to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding a study involving acceptance criteria for an AI/ML device, nor does it provide details about a study proving that a device meets such criteria. The device described is a physical medical implant, not an AI/ML system. Therefore, I cannot extract the requested information from the provided text.

Based on the document, I can provide the following:

Device Name: NuVasive® XLX Interbody System
Device Type: Intervertebral Body Fusion Device (physical implant)
Purpose of Submission: Demonstrate substantial equivalence to predicate devices for regulatory clearance.

Information NOT present in the document which would be needed to answer your request (because the device is not an AI/ML system):

• A table of acceptance criteria and reported device performance (for an AI/ML device)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone (algorithm only) performance
• Type of ground truth used (for an AI/ML device)
• Sample size for the training set
• How ground truth for the training set was established

What the document does provide regarding performance for this physical implant:

1. Acceptance Criteria and Device Performance (Non-AI/ML):

2. Type of Study Done (Non-AI/ML):

Nonclinical performance testing was performed to demonstrate substantial equivalence.

Specific Nonclinical Tests Performed:

• Static and dynamic axial compression testing per ASTM F2077
• Static and dynamic compression-shear testing per ASTM F2077
• Dynamic torsion testing per ASTM F2077
• Static push-out testing per ASTM draft standard F-04.25.02.02 (work item Z8423Z)
• Screw push-out analysis
• Subsidence analysis

Missing Information (as the request is tailored for AI/ML):

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

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