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The NuVasive Modulus XLIF Interbody System is indicated for 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 Modulus XLIF internal fixation, the system is indicated for use with supplemental 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 NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 Modulus XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. An optional internal fixation plate with bone screw(s) manufactured from titanium alloy (Ti-6Al-4V ELI) conforming ASTM F136 or ISO 5832-3 and MP35N conforming to ASTM F562 may be affixed to the adjacent vertebral body or bodies to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screws, 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 implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The purpose of this submission relates to a manufacturing change to the Modulus XLIF interbody implants.

The provided document is a 510(k) premarket notification for the NuVasive Modulus XLIF Interbody System. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.

However, it explicitly states: "No clinical studies were conducted."

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets such criteria in terms of clinical performance. The performance data section refers only to non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices, not clinical efficacy or safety.

Here is a breakdown of what can be answered based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify clinical acceptance criteria or report clinical performance data. It only details non-clinical mechanical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No clinical test set was used as no clinical studies were conducted. The performance data refers to mechanical testing of the implant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No clinical test set was used, and therefore no ground truth was established by experts in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No clinical test set was used, therefore no adjudication method was applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. This device is an interbody fusion system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. This device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. As no clinical studies were performed, no ground truth types for clinical performance were established. The "ground truth" for the non-clinical testing would be the predefined mechanical standards (e.g., ASTM F2077) which the device had to meet or exceed.

8. The sample size for the training set

• Cannot be provided. This device is an implant, not a machine learning model, so there is no concept of a training set in this context.

9. How the ground truth for the training set was established

• Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.

In summary, the provided document focuses on the mechanical substantial equivalence of the NuVasive Modulus XLIF Interbody System to predicate devices, rather than clinical performance or acceptance criteria derived from clinical studies.

Ask a specific question about this device

The NuVasive Modulus XLIF Interbody System is indicated for 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 internal fixation, the system is indicated for use with supplemental 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 NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 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 Modulus XLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6A1-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. An optional internal fixation plate with bone screw manufactured from titanium alloy (Ti-6AI-4V ELI) conforming ASTM F136 or ISO 5832-3 and MP35N conforming to ASTM F562 may be affixed to the adjacent vertebral body or bodies to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screws, 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 implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The purpose of this submission is to introduce an optional dual sided fixation modular plate with bone screws.

This document describes the NuVasive® Modulus® XLIF Interbody System, a medical device for intervertebral body fusion. Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable. The study primarily involved engineering analysis and mechanical testing, not a test set of patient data.
• Data Provenance: Not applicable. The analysis was based on engineering principles and in-vitro mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of Experts and Qualifications

• Number of Experts: Not applicable. This was an engineering and mechanical performance study, not a study requiring expert clinical assessment for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable. This was not a study involving human assessment or interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The text explicitly states, "No clinical studies were conducted." The submission focused on engineering analysis and mechanical performance comparison to predicate devices.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: Not applicable. This device is a physical intervertebral body fusion system, not an algorithm or software. It does not have a "standalone" or "human-in-the-loop" performance in the context of an AI device.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance was established through engineering analysis and adherence to established ASTM standards (specifically ASTM F2077) for mechanical properties. The primary ground truth was comparison to predicate devices deemed safe and effective based on their established performance.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there was no training set for an AI/ML model.

Ask a specific question about this device

The NuVasive Modulus XLIF Interbody System is indicated for 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 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 NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 Modulus XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine.

The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

It looks like you've provided a 510(k) Summary for a medical device (NuVasive® Modulus XLIF Interbody System), but this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, particularly not in the context of an AI/ML-driven medical device.

The document explicitly states: "No clinical studies were conducted." and describes "Non-clinical testing" related to the physical properties of the implant (e.g., static/dynamic compression, shear, gravimetric analysis, etc.). This device is an interbody fusion device, which is a physical implant, not an AI/ML software device.

Therefore, I cannot extract the information you've requested regarding acceptance criteria and a study proving device performance for an AI/ML device from the provided text. The questions you've asked (about sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are highly relevant to AI/ML device validation but are not addressed by this document.

If you can provide a different document that details the validation of an AI/ML medical device, I would be happy to help answer your questions.

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