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The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6Al-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to MLX - Medial Lateral Expandable Lumbar Interbody System (K140770).

This document is a 510(k) premarket notification for a medical device, the NuVasive® MLX™-Medial Lateral Expandable Lumbar Interbody System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document only describes nonclinical testing and Finite Element Analysis (FEA) for the device. Clinical data (human subject testing) for a "test set" in the context of device performance in patients (e.g., efficacy, safety) is not mentioned in this 510(k) summary. The testing described is pre-market, bench-top lab testing for mechanical properties and computational analysis.

Therefore, the concepts of "sample size for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to human patient data are not applicable to the data presented in this particular 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This information is not applicable as the data presented is from nonclinical (bench and computational) testing, not clinical studies requiring expert ground truth for patient outcomes. The "ground truth" here would be the established ASTM standards and engineering principles for mechanical testing and FEA. Product engineers and test lab personnel with relevant expertise would interpret these results.

4. Adjudication Method for the Test Set

This is not applicable as the document describes nonclinical mechanical and computational testing, not clinical studies that typically involve adjudication of patient outcomes or diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This is not applicable. This 510(k) pertains to a physical medical implant (intervertebral body fusion device), not an AI/software device that would typically undergo MRMC studies for diagnostic accuracy or physician assistance.

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

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

For the nonclinical performance data, the "ground truth" is based on:

• Established ASTM standards (e.g., F2077, F2063, F136, F1472) for material properties and mechanical testing.
• Engineering principles and Finite Element Analysis (FEA) models for assessing structural integrity and predicting performance under various loads.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" in the context of machine learning or AI. The testing described focuses on evaluating the physical properties and performance of the manufactured device and its design changes.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in point 8.

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The NuVasive® AP Expandable XLIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion. The AP Expandable XLIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/ rod systems) that are cleared by the FDA for use in the lumbar spine.

The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive Sterile MLX and APX Interbody Devices are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6AI-4V conforming to ASTM 1472, Nitinol SE508 conforming to ASTM F2063, and Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers addition of sterile packaged implants to previously cleared systems.

This document is about the FDA 510(k) clearance of the NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System and NuVasive® AP Expandable XLIF System. It does not describe an AI medical device or a study proving its performance. Thus, I cannot provide the requested information.

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The NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System. The NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, Nitinol SE508 conforming to ASTM F2063, and Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to NuVasive® Expandable Lumbar Interbody System (K130820).

The NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody System, as described in the provided 510(k) summary, is a medical device for intervertebral body fusion. The submission does not detail specific acceptance criteria or an analytical study with defined performance metrics in the way one might expect for a diagnostic or AI-driven device.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the primary "acceptance criteria" were met by proving that the modified design of the MLX System device does not introduce new worst-case performance scenarios compared to the established predicates.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The performance data section refers to "Finite Element Analysis (FEA), anterior shear impact testing, torsional separation testing and engineering rationale." These are typically engineering tests performed on a limited number of physical samples or computational models, not a "test set" of patient data as might be relevant for AI or diagnostic devices. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. For a device like the NuVasive MLX, ground truth is typically established through engineering standards, mechanical testing, and regulatory requirements, not through expert review of a "test set" in the context of diagnostic or AI performance.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective expert review (e.g., for image interpretation). For a mechanical device, performance is typically assessed against quantifiable engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices, particularly those involving image interpretation with or without AI assistance, which is not the nature of the NuVasive MLX device.

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

This information is not applicable/not provided. The NuVasive MLX is a physical implantable device, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The ground truth used for this device's "performance" is based on engineering standards, mechanical testing results, and regulatory requirements (substantial equivalence). This includes:

• ASTM and ISO standards for material composition.
• Results from Finite Element Analysis (FEA).
• Results from anterior shear impact testing.
• Results from torsional separation testing.
• Engineering rationale to demonstrate no new worst-case scenarios.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. The NuVasive MLX is a physical medical device, not an AI or software product that undergoes "training."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

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