Search Results

The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended for allogencis and or allogeneic bone graft comprised of cancellous and/or cortiocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for >20° lordosis is needed, the plated MOD-EX XLIF Interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive MOD-EX XLIF Plated 2.0 Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is intended for use with autogeneic bone graft comprised of cancellous and/or corticocancellous bone graft or a bone void filler as cleared by FDA for use in intervertebral body fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The MOD-EX XLIF Interbody System and MOD-EX XLIF Plated 2.0 Interbody System are 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 degenerative spondylolisthess at one or two adjacent levels, including thoracy disc hemiation (with myelopathy 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 NaVasive MOD-EX XLF Interbody System and NuVasive MOD-EX XLIF Plated 2.0 Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The NuVasive MOD-EX XLIF Interbody System and NuVasive MOD-EX XLIF Plated 2.0 Interbody System are an expandable interbody system, additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3. The NuVasive MOD-EX XLIF Interbody System also includes Nickel-Cobalt-Chromium-Molybdenum (MP35N) conforming to ASTM F562. The NuVasive MOD-EX XLF and NuVasive MOD-EX XLIF Plated 2.0 interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF and NuVasive MOD-EX XLIF Plated 2.0 Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.

The provided text is a 510(k) Premarket Notification from the FDA regarding an Intervertebral Body Fusion Device. It details the device name, indications for use, device description, and performance data used to establish substantial equivalence to predicate devices.

However, the content of this document does not describe a study that proves a device meets acceptance criteria in the context of an AI/ML-driven medical device, nor does it provide a table of acceptance criteria and reported device performance related to such a study.

The performance data section (G) in the document refers to:

• Nonclinical testing for a physical medical device (NuVasive MOD-EX XLIF Plated 2.0 Interbody System), including:
  • Dynamic Axial Compression testing
  • Dynamic torsion testing
  • Gravimetric and Particulate analysis
  • Screw push-out analysis
  • Subsidence analysis
• MRI compatibility testing for the physical device, in accordance with FDA guidance for passive implants in the MR environment, covering:
  • Magnetically induced displacement force
  • Magnetically induced torque
  • Radiofrequency (RF) induced heating
  • MR image artifact

These tests are standard for a physical implantable device to demonstrate its mechanical properties, material properties, and compatibility with MRI. They do not involve acceptance criteria or studies related to AI/ML device performance, such as:

1. A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, accuracy, etc.)
2. Sample sizes for test sets (in terms of patient cases or images)
3. Ground truth establishment by experts (radiologists, pathologists)
4. Adjudication methods
5. Multi-reader multi-case (MRMC) studies
6. Standalone algorithm performance
7. Types of ground truth (e.g., pathology, outcomes data)
8. Training set sample size
9. Ground truth establishment for the training set

Therefore, I cannot extract the requested information from the provided document as it pertains to a different type of medical device (a mechanical implant) and not an AI/ML-driven device.

Ask a specific question about this device

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

The MOD-EX XLIF 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 thoracy 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 MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis and sagittal deformity.

The NuVasive MOD-EX XLIF Interbody System is an expandable interbody system additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001 Class C and traditionally manufactured from both titanium alloy (Ti-6V-4A1 ELI) per ASTM F136 or ISO 5832-3 and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. MOD-EX XLIF interbodies are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The system is designed to address thoracolumbar pathologies utilizing interbody placement through a standard lateral (XLIF) approach. The device features independent threaded drive and wedge mechanisms to allow for independent expansion of the anterior and posterior aspect of the implant. The superior and inferior endplate components are solid and porous structures manufactured simultaneously using a powder bed fusion method. The microporous, textured surfaces on the superior and inferior ends of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The NuVasive MOD-EX XLIF Interbody System interbodies have superior and inferior graft apertures, allowing for packaging of graft to aid in the promotion of a solid fusion.

The provided text is a 510(k) Pre-market Notification for the NuVasive® MOD-EX XLIF Interbody System. This document focuses on demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices, rather than performing a clinical study to establish acceptance criteria based on human expert performance or clinical outcomes.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance against those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types in the context of an AI/software device.

The "Performance Data" section (Page 4, Section G) refers to non-clinical mechanical testing performed to demonstrate substantial equivalence to predicate devices, not clinical performance metrics relevant to AI algorithms or human reading tasks.

• Acceptance Criteria and Reported Device Performance: This information is not present. The document focuses on mechanical testing demonstrating substantial equivalence to predicate devices, not on pre-defined clinical acceptance metrics.
• Sample size used for the test set and the data provenance: Not applicable, as this is a mechanical engineering equivalence study, not an AI/clinical performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study was not performed or referenced.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for spinal fusion, not an AI algorithm.
• The type of ground truth used: Not applicable. The "ground truth" here would be established mechanical engineering standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device